ClinicalTrials.gg
TerminatedNCT06979154PandA-tACSUpdated Sep 28, 2026Results posted

Pilot Study of Personalized Aperiodic Transcranial Alternating Current Stimulation in Antenatal Depression (PandA-tACS)

An interventional study of tACS (aperiodic) in Antenatal Depression, Major Depressive Disorder and Major Depressive Disorder in Pregnancy, sponsored by University of North Carolina, Chapel Hill. Terminated at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Other

Why this study was terminated
Due to lack of resources the study was terminated.
Updated Sep 28, 2026Now TerminatedResults posted+3 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

The purpose of this study is to develop the safety, feasibility, and tolerability of a personalized transcranial alternating current stimulation (tACS) approach in antenatal depression.

Read the detailed description

The purpose of this study is an initial pilot study to develop the safety, feasibility, and tolerability of a novel, individualized transcranial alternating current stimulation (tACS) approach in antenatal depression, which delivers personalized stimulation waveforms based on the aperiodic component of individual participant EEG activity (PandA-tACS). In Phase I, five healthy controls will receive five consecutive days of PandA-tACS. High-density electroencephalography will be collected at Baseline, D1 and D5, as well as intermittently throughout stimulation sessions. Symptoms will be checked at Follow-up 1 (FUP1) (two weeks following intervention). In Phase II, PandA-tACS will be expanded into five patients with antenatal depression with the same study design. In addition to high density (HD) HD-EEG measurements, depression and related symptoms will be measured at D1, D5 in these patients. Depression and related symptoms will be measured again FUP1 (two weeks following intervention) and Follow-up 2 (FUP2) (4-6 weeks post delivery). Birth outcomes will be recorded within 90 days of expected delivery date as an additional form of safety monitoring.

Primary Aim: To investigate the safety, feasibility, and tolerability of five days of PandA-tACS in healthy controls (Phase I) and in participants with antenatal depression (Phase II).

Exploratory Aim: To investigate aperiodic EEG changes following five days of PandA-tACS in healthy controls and in participants with antenatal depression. Additionally, changes in depression symptoms will be investigated two weeks following PandA-tACS in antenatal depression.

02

Conditions studied

  • Antenatal Depression
  • Major Depressive Disorder
  • Major Depressive Disorder in Pregnancy
  • Healthy Controls

Keywords

  • Behavioral Symptoms
  • Mood Disorders
  • Mental Disorders
  • Depression
  • Depressive Disorder
  • Major Depressive Disorder
  • Antenatal diagnoses
  • Prenatal diagnoses
  • Pregnancy
  • Electric Stimulation
  • non-invasive brain stimulation
  • transcranial alternating current stimulation
  • tACS
  • EEG
  • antenatal depression
  • Healthy Controls
  • Aperiodic brain activity
03

In context

Depressive Disorder, Major

3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.

This study's enrollment of 6 is below the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.

Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Sep 28, 2026. See what changed

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • Female aged 18 - 45
  • Capacity to understand all relevant risks and potential benefits of the study as determined by study staff (provision of )
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Low suicide risk (defined for this study as no active suicidal ideation in the past month and no suicide attempts, preparatory actions, or significant non-suicidal self-harm in the previous 2 years). Risk will be assessed utilizing the Columbia Suicide Severity Rating Scale (C-SSRS) screen and triage version with further exploration of positive responses.

For healthy control population:

  • Use of highly effective for at least 1 month prior to screening and agreement to use such a method during study participation, according to NIH Therapeutics Research Program Guidelines.

Additional for antenatal depression population:

  • Between weeks 14-32 of viable singleton pregnancy
  • Established obstetric care through UNC
  • Pre-identified Diagnostic and Statistical Manual-5 () diagnosis of unipolar, non-psychotic Major depressive disorder (MDD) which is confirmed by the DIAMOND
  • Hamilton Depression Rating Scale-17 (HDRS-17) score ≥8

Exclusion criteria

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

  • diagnosis of severe alcohol use disorder (AUD) within the last 12 months, as evidenced by the DIAMOND
  • DSM-5 diagnosis of moderate to severe substance use disorder (excluding tobacco) within the last 12 months, as evidenced by the DIAMOND
  • Lifetime history of bipolar disorder, as evidenced by DIAMOND
  • Schizophrenia spectrum and other psychotic disorders, as evidenced by DIAMOND
  • History of autism spectrum disorder
  • Initiated any new psychotropic medication in the 6 weeks prior to screening or had a dose change in the preceding 6 weeks
  • Initiated a new course of psychotherapy in the 6 weeks preceding screening
  • Received any neurostimulation treatment in the 6 weeks preceding screening
  • History of seizures (excluding febrile seizures in childhood or Electroconvulsive Therapy (ECT) induced seizures)
  • Neurological disorders that would increase risk of participation or present a significant confounder in the opinion of the investigator (for example, dementia, history of stroke, Parkinson's disease, multiple sclerosis, history of traumatic brain injury with prolonged loss of consciousness, ruptured cerebral aneurysm, previous Central nervous system (CNS) radiation)
  • Previously failed to respond to ECT or transcranial magnetic stimulation (TMS)
  • Prior brain surgery and/or brain implants
  • Implanted medical device that uses electricity
  • Currently enrolled in another clinical trial for depression
  • Unstable medical disorder or anything that would place the participant at increased risk or preclude the participant's full compliance with or completion of the study, in the opinion of the Investigator

Additional for the healthy control population:

  • Current pregnancy or lactation (as determined by urine pregnancy test)
  • History of depression, as evidenced by DIAMOND

Additional for the antenatal depression population:

  • History of any of the following conditions:

    • Diabetes (gestational or general history)
    • Pre-term delivery (\<37 weeks)
    • Eclampsia
    • Pre-eclampsia with severe features
    • Asthma requiring daily medication
    • Chronic hypertension
    • Immune thrombocytopenia (ITP)
    • Hyperthyroidism requiring medication
    • Pre-pregnancy 40 or more
    • In vitro fertilization (IVF)
    • Mullerian anomaly of uterus
    • Organ transplant
    • Prior history of deep vein thrombosis/pulmonary embolism (DVT/PE) or plan for anticoagulation during pregnancy
    • Fetus with hydrops
    • Abnormal placenta
  • Current pregnancy:

    • /Hep B/Hep C with detectable viral loads
    • Anemia [ under 11.0] upon entry to prenatal care
    • No scheduled prenatal visits by 15 weeks
    • Placenta previa
    • Placenta accreta spectrum (PAS)
    • Pre-eclampsia
    • Gestational diabetes
    • Gestational hypertension
    • Fetus with abnormal chromosomes
    • Cervical length \< 2.5 cm
    • Presence of cerclage or vaginal progesterone to decrease chance of pre-term labor
    • Fetal growth restriction
    • Macrosomia
    • Polyhydramnios
    • Oligohydramnios
    • Rupture of membranes
    • Hyperemesis Gravidarum (HEG)
    • Confirmation testing for Tri 13/18/21
    • Congenital anomalies on anatomy ultrasound that do not resolve with follow-up ultrasound
  • Other cause of markedly high-risk pregnancy as determined by the Investigator
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Healthy Control Group

    Aperiodic tACS delivered using a waveform based on individual participant EEG activity which has been modified to alter excitation/inhibition balance.

    Device: tACS (aperiodic)

  • Experimental
    Antenatal Depression Group

    Aperiodic tACS delivered using a waveform based on individual participant EEG activity which has been modified to alter excitation/inhibition balance.

    Device: tACS (aperiodic)

Interventions

  • DevicetACS (aperiodic)

    Individualized tACS waveform based on aperiodic EEG activity will be delivered.

06

What researchers measure

Primary outcomes

  1. Safety Via the Presence of Any Serious AEs Related to Stimulation

    The number of serious adverse events reported in healthy control and antenatal depression groups.

    Time frame: Healthy controls: Day 1 through Follow-up 1 (Day 19). Antenatal depression participants: Day 1 through birth outcome assessment within 90 days after delivery, up to 17 weeks after Day 1.

  2. Feasibility Via the Number of Participants Enrolled Relative to the Target Recruitment in Each Group

    The number of participants enrolled relative to the target recruitment of five participants in each of the healthy control and antenatal depression groups over the specified 12-month period

    Time frame: Baseline to end of recruitment period (12 months following recruitment start)

  3. Feasibility Via the Number of Participants Completing All Study Visits Within the Intervention Period

    The number of participants who complete all study visits within the intervention period in the healthy control and antenatal depression groups.

    Time frame: Baseline (up to 7 days before intervention Day 1) to Day 5 (end of five-day intervention)

  4. Tolerability Via the Number of Participants Rating Stimulation-related Sensations as 'High'

    The number of participants who rate stimulation-related sensations as 'high' within the intervention period in the healthy control and antenatal depression groups.

    Time frame: Day 1 to Day 5

  5. Tolerability Via the Proportion of Participants Reporting Intolerance to Stimulation

    The proportion of participants who are unable to tolerate stimulation within the intervention period in the healthy control and antenatal depression groups.

    Time frame: Day 1 to Day 5

  6. Safety Via Review of Birth Outcomes Within 90 Days of Birth in the Antenatal Depression Population

    The number of adverse birth outcomes in participants with antenatal depression. Review will consider length of pregnancy in days, delivery (spontaneous, induced, cesarian (planned or acute), vaginal birth, forceps and/or vacuum extraction), gestational age at birth, Apgar 5 min, malformation, child weight at birth in grams, birth size (small for gestational age, appropriate for gestational age, large for gestational age), neonatal need for intensive care, stillbirth, maternal length of stay in hospital, maternal need for intensive care, pre-eclampsia, as well as EPDS score between 2-4 weeks post-delivery .

    Time frame: Healthy controls: Day 1 through Follow-up 1 (Day 19). Antenatal depression participants: Day 1 through birth outcome assessment within 90 days after delivery, up to 17 weeks after Day 1.

Other outcomes

  1. Change in Aperiodic Exponent Following the Five-day PandA-tACS Intervention

    The change in aperiodic exponent from resting state EEG recordings on the first day and the final day of stimulation in healthy control and antenatal depression populations.

    Time frame: Day 1 to Day 5

  2. Change in HDRS-17 Score Following Intervention in the Antenatal Depression Population

    The HDRS-17 is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 52. A higher score indicates a worse outcome. Investigators will determine the change in scores across the intervention from Day 1 to Day 5, Day 1 to Follow-up 1, Day 5 to Follow-up 1

    Time frame: Day 1 up to Follow-up 1 (2 weeks post-stimulation)

  3. Change in Edinburgh Postnatal Depression Scale (EPDS) in the Antenatal Depression Population

    The EPDS is a self-administered questionnaire designed to screen for potential symptoms of depression during pregnancy and the postpartum period. This scale consists of 10 short statements, where the participant checks off one of four possible answers about how they have been feeling for the past week. Responses are scored from 0-3, where total scores above 12 or 13 are likely to be suffering from depression. Investigators will determine the change in scores between across the intervention from Day 1 to Day 5, Day 1 to Follow-up 1, Day 5 to Follow-up 1.

    Time frame: Day 1 up to Follow-up 1 (2 weeks post-stimulation)

  4. Change in Snaith-Hamilton Pleasure Scale (SHAPS) in the Antenatal Depression Population

    The SHAPS is a 14-item scale which assesses for anhedonia (the inability to experience pleasure) where each item has a set of four response categories (definitely agree=1, agree=2, disagree=3, definitely disagree=4). Participants are considered to be experiencing mild anhedonia if they disagree with three or more statements. Participants can agree or disagree on a minimum of 0 and maximum of 14 statements. Investigators will determine the change in scores across the intervention from Day 1 to Day 5, Day 1 to Follow-up 1, Day 5 to Follow-up 1.

    Time frame: Day 1 up to Follow-up 1 (2 weeks post-stimulation)

  5. Change in Clinical Global Impression Scale (CGI) in the Antenatal Depression Population

    The CGI is a measure of symptom severity, treatment response and the efficacy of treatments. The CGI involves a single question for the clinician, who rates how mentally ill the participant is, on a scale from 1 (normal), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill) and 7 (among the most extremely ill participants). Investigators will determine the change in scores across the intervention from Day 1 to Day 5, Day 1 to Follow-up 1, Day 5 to Follow-up 1.

    Time frame: Day 1 up to Follow-up 1 (2 weeks post-stimulation)

  6. Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) in the Antenatal Depression Population

    The Q-LES-Q-SF is a self-report measure of enjoyment and satisfaction in daily functioning. The total score ranges from 14 to 70, and is expressed as a percentage of the maximum total score that is achievable, where a percentage score ranging from 70-100 is generally indicative of a normal population. Investigators will determine the change in scores across the intervention by comparing scores from Day 1 to Day 5, Day 1 to Follow-up 1, Day 5 to Follow-up 1.

    Time frame: Day 1 up to Follow-up 1 (2 weeks post-stimulation)

  7. Change in HDRS-17 Score Following Intervention in the Antenatal Depression Population (Postnatal Period)

    The HDRS-17 is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 52. A higher score indicates a worse outcome. Investigators will determine the change in scores across the intervention from Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)

    Time frame: Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)

  8. Change in Edinburgh Postnatal Depression Scale (EPDS) in the Antenatal Depression Population (Postnatal Period)

    The EPDS is a self-administered questionnaire designed to screen for potential symptoms of depression during pregnancy and the postpartum period. This scale consists of 10 short statements, where the participant checks off one of four possible answers about how they have been feeling for the past week. Responses are scored from 0-3, where total scores above 12 or 13 are likely to be suffering from depression. Investigators will determine the change in scores between Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)

    Time frame: Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)

  9. Change in Snaith-Hamilton Pleasure Scale (SHAPS) in the Antenatal Depression Population (Postnatal Period)

    The SHAPS is a 14-item scale which assesses for anhedonia (the inability to experience pleasure) where each item has a set of four response categories (definitely agree=1, agree=2, disagree=3, definitely disagree=4). Participants are considered to be experiencing mild anhedonia if they disagree with three or more statements. Participants can agree or disagree on a minimum of 0 and maximum of 14 statements. Investigators will determine the change in scores across the intervention from Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)

    Time frame: Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)

  10. Change in Clinical Global Impression Scale (CGI) in the Antenatal Depression Population (Postnatal Period)

    The CGI is a measure of symptom severity, treatment response and the efficacy of treatments. The CGI involves a single question for the clinician, who rates how mentally ill the participant is, on a scale from 1 (normal), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill) and 7 (among the most extremely ill participants). Investigators will determine the change in scores across the intervention from Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)

    Time frame: Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)

  11. Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) in the Antenatal Depression Population (Postnatal Period)

    The Q-LES-Q-SF is a self-report measure of enjoyment and satisfaction in daily functioning. The total score ranges from 14 to 70, and is expressed as a percentage of the maximum total score that is achievable, where a percentage score ranging from 70-100 is generally indicative of a normal population. Investigators will determine the change in scores across the intervention by comparing scores from Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)

    Time frame: Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)

07

Results

Posted Sep 28, 2026

Participant flow

Healthy Control Exposure
Participant flow — Healthy Control Exposure
MilestoneHealthy Control GroupAntenatal Depression Group
Started50
Completed50
Not completed00
Antenatal Depression Exposure
Participant flow — Antenatal Depression Exposure
MilestoneHealthy Control GroupAntenatal Depression Group
Started01
Completed01
Not completed00

Outcome measures

PrimarySafety Via the Presence of Any Serious AEs Related to Stimulation

The number of serious adverse events reported in healthy control and antenatal depression groups.

Time frame:
Healthy controls: Day 1 through Follow-up 1 (Day 19). Antenatal depression participants: Day 1 through birth outcome assessment within 90 days after delivery, up to 17 weeks after Day 1.
Reported as:
Number · Serious adverse events
Safety Via the Presence of Any Serious AEs Related to Stimulation
Serious adverse eventsHealthy Control GroupAntenatal Depression Group
Safety Via the Presence of Any Serious AEs Related to Stimulation00
PrimaryFeasibility Via the Number of Participants Enrolled Relative to the Target Recruitment in Each Group

The number of participants enrolled relative to the target recruitment of five participants in each of the healthy control and antenatal depression groups over the specified 12-month period

Time frame:
Baseline to end of recruitment period (12 months following recruitment start)
Reported as:
Number · percent of participants
Feasibility Via the Number of Participants Enrolled Relative to the Target Recruitment in Each Group
percent of participantsHealthy Control GroupAntenatal Depression Group
Feasibility Via the Number of Participants Enrolled Relative to the Target Recruitment in Each Group10020
PrimaryFeasibility Via the Number of Participants Completing All Study Visits Within the Intervention Period

The number of participants who complete all study visits within the intervention period in the healthy control and antenatal depression groups.

Time frame:
Baseline (up to 7 days before intervention Day 1) to Day 5 (end of five-day intervention)
Reported as:
Count of participants · Participants
Feasibility Via the Number of Participants Completing All Study Visits Within the Intervention Period
ParticipantsHealthy Control GroupAntenatal Depression Group
Feasibility Via the Number of Participants Completing All Study Visits Within the Intervention Period51
PrimaryTolerability Via the Number of Participants Rating Stimulation-related Sensations as 'High'

The number of participants who rate stimulation-related sensations as 'high' within the intervention period in the healthy control and antenatal depression groups.

Time frame:
Day 1 to Day 5
Reported as:
Count of participants · Participants
Tolerability Via the Number of Participants Rating Stimulation-related Sensations as 'High'
ParticipantsHealthy Control GroupAntenatal Depression Group
Tolerability Via the Number of Participants Rating Stimulation-related Sensations as 'High'31
PrimaryTolerability Via the Proportion of Participants Reporting Intolerance to Stimulation

The proportion of participants who are unable to tolerate stimulation within the intervention period in the healthy control and antenatal depression groups.

Time frame:
Day 1 to Day 5
Reported as:
Number · proportion of participants
Tolerability Via the Proportion of Participants Reporting Intolerance to Stimulation
proportion of participantsHealthy Control GroupAntenatal Depression Group
Tolerability Via the Proportion of Participants Reporting Intolerance to Stimulation00
PrimarySafety Via Review of Birth Outcomes Within 90 Days of Birth in the Antenatal Depression Population

The number of adverse birth outcomes in participants with antenatal depression. Review will consider length of pregnancy in days, delivery (spontaneous, induced, cesarian (planned or acute), vaginal birth, forceps and/or vacuum extraction), gestational age at birth, Apgar 5 min, malformation, child weight at birth in grams, birth size (small for gestational age, appropriate for gestational age, large for gestational age), neonatal need for intensive care, stillbirth, maternal length of stay in hospital, maternal need for intensive care, pre-eclampsia, as well as EPDS score between 2-4 weeks post-delivery .

Time frame:
Healthy controls: Day 1 through Follow-up 1 (Day 19). Antenatal depression participants: Day 1 through birth outcome assessment within 90 days after delivery, up to 17 weeks after Day 1.
Reported as:
Number · Adverse events
Safety Via Review of Birth Outcomes Within 90 Days of Birth in the Antenatal Depression Population
Adverse eventsHealthy Control GroupAntenatal Depression Group
Safety Via Review of Birth Outcomes Within 90 Days of Birth in the Antenatal Depression Population—0
Other pre-specifiedChange in Aperiodic Exponent Following the Five-day PandA-tACS Intervention

The change in aperiodic exponent from resting state EEG recordings on the first day and the final day of stimulation in healthy control and antenatal depression populations.

Time frame:
Day 1 to Day 5

Results for this outcome have not been posted.

Other pre-specifiedChange in HDRS-17 Score Following Intervention in the Antenatal Depression Population

The HDRS-17 is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 52. A higher score indicates a worse outcome. Investigators will determine the change in scores across the intervention from Day 1 to Day 5, Day 1 to Follow-up 1, Day 5 to Follow-up 1

Time frame:
Day 1 up to Follow-up 1 (2 weeks post-stimulation)

Results for this outcome have not been posted.

Other pre-specifiedChange in Edinburgh Postnatal Depression Scale (EPDS) in the Antenatal Depression Population

The EPDS is a self-administered questionnaire designed to screen for potential symptoms of depression during pregnancy and the postpartum period. This scale consists of 10 short statements, where the participant checks off one of four possible answers about how they have been feeling for the past week. Responses are scored from 0-3, where total scores above 12 or 13 are likely to be suffering from depression. Investigators will determine the change in scores between across the intervention from Day 1 to Day 5, Day 1 to Follow-up 1, Day 5 to Follow-up 1.

Time frame:
Day 1 up to Follow-up 1 (2 weeks post-stimulation)

Results for this outcome have not been posted.

Other pre-specifiedChange in Snaith-Hamilton Pleasure Scale (SHAPS) in the Antenatal Depression Population

The SHAPS is a 14-item scale which assesses for anhedonia (the inability to experience pleasure) where each item has a set of four response categories (definitely agree=1, agree=2, disagree=3, definitely disagree=4). Participants are considered to be experiencing mild anhedonia if they disagree with three or more statements. Participants can agree or disagree on a minimum of 0 and maximum of 14 statements. Investigators will determine the change in scores across the intervention from Day 1 to Day 5, Day 1 to Follow-up 1, Day 5 to Follow-up 1.

Time frame:
Day 1 up to Follow-up 1 (2 weeks post-stimulation)

Results for this outcome have not been posted.

Other pre-specifiedChange in Clinical Global Impression Scale (CGI) in the Antenatal Depression Population

The CGI is a measure of symptom severity, treatment response and the efficacy of treatments. The CGI involves a single question for the clinician, who rates how mentally ill the participant is, on a scale from 1 (normal), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill) and 7 (among the most extremely ill participants). Investigators will determine the change in scores across the intervention from Day 1 to Day 5, Day 1 to Follow-up 1, Day 5 to Follow-up 1.

Time frame:
Day 1 up to Follow-up 1 (2 weeks post-stimulation)

Results for this outcome have not been posted.

Other pre-specifiedChange in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) in the Antenatal Depression Population

The Q-LES-Q-SF is a self-report measure of enjoyment and satisfaction in daily functioning. The total score ranges from 14 to 70, and is expressed as a percentage of the maximum total score that is achievable, where a percentage score ranging from 70-100 is generally indicative of a normal population. Investigators will determine the change in scores across the intervention by comparing scores from Day 1 to Day 5, Day 1 to Follow-up 1, Day 5 to Follow-up 1.

Time frame:
Day 1 up to Follow-up 1 (2 weeks post-stimulation)

Results for this outcome have not been posted.

Other pre-specifiedChange in HDRS-17 Score Following Intervention in the Antenatal Depression Population (Postnatal Period)

The HDRS-17 is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 52. A higher score indicates a worse outcome. Investigators will determine the change in scores across the intervention from Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)

Time frame:
Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)

Results for this outcome have not been posted.

Other pre-specifiedChange in Edinburgh Postnatal Depression Scale (EPDS) in the Antenatal Depression Population (Postnatal Period)

The EPDS is a self-administered questionnaire designed to screen for potential symptoms of depression during pregnancy and the postpartum period. This scale consists of 10 short statements, where the participant checks off one of four possible answers about how they have been feeling for the past week. Responses are scored from 0-3, where total scores above 12 or 13 are likely to be suffering from depression. Investigators will determine the change in scores between Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)

Time frame:
Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)

Results for this outcome have not been posted.

Other pre-specifiedChange in Snaith-Hamilton Pleasure Scale (SHAPS) in the Antenatal Depression Population (Postnatal Period)

The SHAPS is a 14-item scale which assesses for anhedonia (the inability to experience pleasure) where each item has a set of four response categories (definitely agree=1, agree=2, disagree=3, definitely disagree=4). Participants are considered to be experiencing mild anhedonia if they disagree with three or more statements. Participants can agree or disagree on a minimum of 0 and maximum of 14 statements. Investigators will determine the change in scores across the intervention from Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)

Time frame:
Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)

Results for this outcome have not been posted.

Other pre-specifiedChange in Clinical Global Impression Scale (CGI) in the Antenatal Depression Population (Postnatal Period)

The CGI is a measure of symptom severity, treatment response and the efficacy of treatments. The CGI involves a single question for the clinician, who rates how mentally ill the participant is, on a scale from 1 (normal), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill) and 7 (among the most extremely ill participants). Investigators will determine the change in scores across the intervention from Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)

Time frame:
Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)

Results for this outcome have not been posted.

Other pre-specifiedChange in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) in the Antenatal Depression Population (Postnatal Period)

The Q-LES-Q-SF is a self-report measure of enjoyment and satisfaction in daily functioning. The total score ranges from 14 to 70, and is expressed as a percentage of the maximum total score that is achievable, where a percentage score ranging from 70-100 is generally indicative of a normal population. Investigators will determine the change in scores across the intervention by comparing scores from Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)

Time frame:
Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)

Results for this outcome have not been posted.

Adverse events

Collected over All adverse events that occurred any time after informed consent was obtained until 7 days for Other (not including serious) adverse events or 30 days for Serious Adverse Events and unanticipated adverse device events after the last day of study participation (for healthy control group: 14 weeks after informed consent was obtained; for antenatal depression group: up to 19 weeks after informed consent was obtained).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Healthy Control Group0/5 (0%)0/5 (0%)0/5 (0%)
Antenatal Depression Group0/1 (0%)0/1 (0%)1/1 (100%)
Most frequent other events
Most frequent other events
EventHealthy Control GroupAntenatal Depression Group
"High" rated Tingling sensation during stimulationNervous system disorders0/51/1

Baseline characteristics

Age, Continuous
Age, Continuous(years)Healthy Control GroupAntenatal Depression GroupTotal
Mean34.0 ± 7.928.0 ± NA33.0 ± 7.5
Sex: Female, Male
Sex: Female, Male(Participants)Healthy Control GroupAntenatal Depression GroupTotal
Female516
Male000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Healthy Control GroupAntenatal Depression GroupTotal
American Indian or Alaska Native000
Asian202
Native Hawaiian or Other Pacific Islander000
Black or African American000
White314
More than one race000
Unknown or Not Reported000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Healthy Control GroupAntenatal Depression GroupTotal
Hispanic or Latino000
Not Hispanic or Latino516
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)Healthy Control GroupAntenatal Depression GroupTotal
United States516
08

Study locations

1 site
  • Carolina Center for Neurostimulation
    Chapel Hill, North Carolina 27516, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — Individual participant data will not be shared in this study due to the small sample size, which may cause participants to become identifiable.

10

Updates

1 registry update since Sep 25, 2026
Status
Completed→Terminated Due to lack of resources the study was terminated.
changed Sep 28, 2026
Results
Results posted
posted Sep 28, 2026
Eligibility
3 inclusion criteria edited; 1 exclusion criterion edited
What changed in the criteria
Inclusion criteria
  • EditedLow suicide risk (defined for this study as no active suicidal ideation in the past month and no suicide attempts, preparatory actions, or significant non-suicidal self-harm in the previous 2 years). Risk will be assessed utilizing the Columbia Suicide Severity Rating Scale (C-SSRS) screen and triage version with further exploration of positive responses.
  • EditedPre-identified Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of unipolar, non-psychotic Major depressive disorder (MDD) which is confirmed by the DIAMOND
  • EditedHamilton Depression Rating Scale-17 (HDRS-17) score ≥8
Exclusion criteria
  • EditedNeurological disorders that would increase risk of participation or present a significant confounder in the opinion of the investigator (for example, dementia, history of stroke, Parkinson's disease, multiple sclerosis, history of traumatic brain injury with prolonged loss of consciousness, ruptured cerebral aneurysm, previous Central nervous system (CNS) radiation)
Sep 28, 2026
Primary outcomes
6 edited
What changed in the outcomes
  • EditedSafety viaVia the presencePresence of any seriousAny Serious AEs relatedRelated to stimulationStimulationTime frame: Day 1 to Follow-Up (Day 19) (HC) or Day 1 to end of monitoring (birth outcomes review within 90 days of expected delivery date) (antenatal depression) → Healthy controls: Day 1 through Follow-up 1 (Day 19). Antenatal depression participants: Day 1 through birth outcome assessment within 90 days after delivery, up to 17 weeks after Day 1.
  • EditedFeasibility viaVia the numberNumber of participants enrolled relativeParticipants Enrolled Relative to the target recruitmentTarget Recruitment in each groupEach GroupTime frame: Baseline to end of recruitment period (12 months following recruitment start)
  • EditedFeasibility viaVia the numberNumber of participants completing all study visits withinParticipants Completing All Study Visits Within the intervention and follow-up periodIntervention PeriodTime frame: Healthy controls: Baseline to Follow-Up (Day 19); antenatal depression group: Baseline to Day 5 → Baseline (up to 7 days before intervention Day 1) to Day 5 (end of five-day intervention)
  • EditedTolerability viaVia the proportionNumber of participants rating stimulationParticipants Rating Stimulation-related sensationsSensations as 'highHigh'Time frame: Day 1 to Day 5
  • EditedTolerability viaVia the proportionProportion of participants reporting intoleranceParticipants Reporting Intolerance to stimulationStimulationTime frame: Day 1 to Day 5
  • EditedSafety via reviewVia Review of birth outcomes withinBirth Outcomes Within 90 daysDays of birthBirth in the antenatal depression populationAntenatal Depression PopulationTime frame: Baseline to end of monitoring (birth outcomes review within 90 days of expected delivery date) → Healthy controls: Day 1 through Follow-up 1 (Day 19). Antenatal depression participants: Day 1 through birth outcome assessment within 90 days after delivery, up to 17 weeks after Day 1.
Sep 28, 2026
Documents
Secondary outcomes
11 edited
What changed in the outcomes
  • Editedother outcomeChange in aperiodic exponent followingAperiodic Exponent Following the fiveFive-day PandA-tACS interventionInterventionTime frame: Day 1 to Day 5
  • Editedother outcomeChange in HDRS-17 score following interventionScore Following Intervention in the antenatal depression populationAntenatal Depression PopulationTime frame: Day 1 up to Follow-up 1 (2 weeks post-stimulation)
  • Editedother outcomeChange in Edinburgh Postnatal Depression Scale (EPDS) in the antenatal depression populationAntenatal Depression PopulationTime frame: Day 1 up to Follow-up 1 (2 weeks post-stimulation)
  • Editedother outcomeChange in Snaith-Hamilton Pleasure Scale (SHAPS) in the antenatal depression populationAntenatal Depression PopulationTime frame: Day 1 up to Follow-up 1 (2 weeks post-stimulation)
  • Editedother outcomeChange in Clinical Global Impression Scale (CGI) in the antenatal depression populationAntenatal Depression PopulationTime frame: Day 1 up to Follow-up 1 (2 weeks post-stimulation)
  • Editedother outcomeChange in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) in the antenatal depression populationAntenatal Depression PopulationTime frame: Day 1 up to Follow-up 1 (2 weeks post-stimulation)
  • Editedother outcomeChange in HDRS-17 score following interventionScore Following Intervention in the antenatal depression populationAntenatal Depression Population (postnatal periodPostnatal Period)Time frame: Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)
  • Editedother outcomeChange in Edinburgh Postnatal Depression Scale (EPDS) in the antenatal depression populationAntenatal Depression Population (postnatal periodPostnatal Period)Time frame: Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)
  • Editedother outcomeChange in Snaith-Hamilton Pleasure Scale (SHAPS) in the antenatal depression populationAntenatal Depression Population (postnatal periodPostnatal Period)Time frame: Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)
  • Editedother outcomeChange in Clinical Global Impression Scale (CGI) in the antenatal depression populationAntenatal Depression Population (postnatal periodPostnatal Period)Time frame: Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)
  • Editedother outcomeChange in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) in the antenatal depression populationAntenatal Depression Population (postnatal periodPostnatal Period)Time frame: Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Completed→Terminated
    Why stopped Due to lack of resources the study was terminated.
    Results posted
    Eligibility 3 inclusion criteria edited; 1 exclusion criterion edited
    What changed in the criteria
    Inclusion criteria
    • EditedLow suicide risk (defined for this study as no active suicidal ideation in the past month and no suicide attempts, preparatory actions, or significant non-suicidal self-harm in the previous 2 years). Risk will be assessed utilizing the Columbia Suicide Severity Rating Scale (C-SSRS) screen and triage version with further exploration of positive responses.
    • EditedPre-identified Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of unipolar, non-psychotic Major depressive disorder (MDD) which is confirmed by the DIAMOND
    • EditedHamilton Depression Rating Scale-17 (HDRS-17) score ≥8
    Exclusion criteria
    • EditedNeurological disorders that would increase risk of participation or present a significant confounder in the opinion of the investigator (for example, dementia, history of stroke, Parkinson's disease, multiple sclerosis, history of traumatic brain injury with prolonged loss of consciousness, ruptured cerebral aneurysm, previous Central nervous system (CNS) radiation)
    Primary outcomes 6 edited
    What changed in the outcomes
    • EditedSafety viaVia the presencePresence of any seriousAny Serious AEs relatedRelated to stimulationStimulationTime frame: Day 1 to Follow-Up (Day 19) (HC) or Day 1 to end of monitoring (birth outcomes review within 90 days of expected delivery date) (antenatal depression) → Healthy controls: Day 1 through Follow-up 1 (Day 19). Antenatal depression participants: Day 1 through birth outcome assessment within 90 days after delivery, up to 17 weeks after Day 1.
    • EditedFeasibility viaVia the numberNumber of participants enrolled relativeParticipants Enrolled Relative to the target recruitmentTarget Recruitment in each groupEach GroupTime frame: Baseline to end of recruitment period (12 months following recruitment start)
    • EditedFeasibility viaVia the numberNumber of participants completing all study visits withinParticipants Completing All Study Visits Within the intervention and follow-up periodIntervention PeriodTime frame: Healthy controls: Baseline to Follow-Up (Day 19); antenatal depression group: Baseline to Day 5 → Baseline (up to 7 days before intervention Day 1) to Day 5 (end of five-day intervention)
    • EditedTolerability viaVia the proportionNumber of participants rating stimulationParticipants Rating Stimulation-related sensationsSensations as 'highHigh'Time frame: Day 1 to Day 5
    • EditedTolerability viaVia the proportionProportion of participants reporting intoleranceParticipants Reporting Intolerance to stimulationStimulationTime frame: Day 1 to Day 5
    • EditedSafety via reviewVia Review of birth outcomes withinBirth Outcomes Within 90 daysDays of birthBirth in the antenatal depression populationAntenatal Depression PopulationTime frame: Baseline to end of monitoring (birth outcomes review within 90 days of expected delivery date) → Healthy controls: Day 1 through Follow-up 1 (Day 19). Antenatal depression participants: Day 1 through birth outcome assessment within 90 days after delivery, up to 17 weeks after Day 1.
    Secondary outcomes 11 edited
    What changed in the outcomes
    • Editedother outcomeChange in aperiodic exponent followingAperiodic Exponent Following the fiveFive-day PandA-tACS interventionInterventionTime frame: Day 1 to Day 5
    • Editedother outcomeChange in HDRS-17 score following interventionScore Following Intervention in the antenatal depression populationAntenatal Depression PopulationTime frame: Day 1 up to Follow-up 1 (2 weeks post-stimulation)
    • Editedother outcomeChange in Edinburgh Postnatal Depression Scale (EPDS) in the antenatal depression populationAntenatal Depression PopulationTime frame: Day 1 up to Follow-up 1 (2 weeks post-stimulation)
    • Editedother outcomeChange in Snaith-Hamilton Pleasure Scale (SHAPS) in the antenatal depression populationAntenatal Depression PopulationTime frame: Day 1 up to Follow-up 1 (2 weeks post-stimulation)
    • Editedother outcomeChange in Clinical Global Impression Scale (CGI) in the antenatal depression populationAntenatal Depression PopulationTime frame: Day 1 up to Follow-up 1 (2 weeks post-stimulation)
    • Editedother outcomeChange in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) in the antenatal depression populationAntenatal Depression PopulationTime frame: Day 1 up to Follow-up 1 (2 weeks post-stimulation)
    • Editedother outcomeChange in HDRS-17 score following interventionScore Following Intervention in the antenatal depression populationAntenatal Depression Population (postnatal periodPostnatal Period)Time frame: Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)
    • Editedother outcomeChange in Edinburgh Postnatal Depression Scale (EPDS) in the antenatal depression populationAntenatal Depression Population (postnatal periodPostnatal Period)Time frame: Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)
    • Editedother outcomeChange in Snaith-Hamilton Pleasure Scale (SHAPS) in the antenatal depression populationAntenatal Depression Population (postnatal periodPostnatal Period)Time frame: Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)
    • Editedother outcomeChange in Clinical Global Impression Scale (CGI) in the antenatal depression populationAntenatal Depression Population (postnatal periodPostnatal Period)Time frame: Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)
    • Editedother outcomeChange in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) in the antenatal depression populationAntenatal Depression Population (postnatal periodPostnatal Period)Time frame: Follow-up 1 (2 weeks post-stimulation) to Follow-up 2 (4-6 weeks post delivery)
    + 2 other changes: index terms and description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT06979154
Collaborators
Brain & Behavior Research Foundation, Michigan State University
Responsible party
Sponsor
First posted
May 18, 2025
Start date
Aug 12, 2025
Primary completion
Jun 29, 2026
Completion
Jun 29, 2026
Results posted
Sep 28, 2026
Last update
Sep 28, 2026

Study contacts

Flavio Frohlich, PhD, MSc ETH, MA
principal investigator · University of North Carolina, Chapel Hill

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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