An interventional study of Sham (placebo) tACS and IAF-tACS in Antenatal Depression, sponsored by University of North Carolina, Chapel Hill. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Basic science
The purpose of this pilot trial is to primarily assess safety, feasibility, and tolerability of PandA-tACS in antenatal depression and determine whether a single PandA-tACS session produces greater left dlPFC aperiodic slope flattening (reduction) from pre- to post-stimulation than IAF-tACS and sham.
The purpose of this study is to evaluate the safety, feasibility, tolerability, and brain effects of a single session of a personalized form of non-invasive brain stimulation called PandA-tACS in individuals with antenatal depression. PandA-tACS uses each participant's own EEG activity to create an individualized stimulation waveform. Participants will be females aged 18-45 years who are 14-32 weeks pregnant with a viable, low-risk singleton pregnancy and meet criteria for unipolar, non-psychotic major depressive disorder. Participants must be at low suicide risk, and be able to complete study procedures.
Participants will complete screening, informed consent, clinical assessments, pregnancy safety review, and high-density EEG recordings. Eligible participants will attend one in-person stimulation visit and will be randomized to receive PandA-tACS, individualized alpha-frequency tACS, or sham stimulation. Stimulation will be delivered through scalp electrodes while participants are monitored by trained study staff. EEG, symptom ratings, blood pressure, pre-natal safety checks, and adverse event monitoring will be completed before and/or after stimulation. Optional MRI may be completed for electric-field modeling. Pregnancy and birth outcomes will be reviewed through the medical record.
561 studies on the registry are indexed under Mood Disorders; 105 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 419 interventional studies indexed under Mood Disorders.
Browse Mood Disorders studies →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.
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.
Exclusion Criteria:
History of any of the following conditions:
Current pregnancy:
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.
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.
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.
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.
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.
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.
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).
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive sham tACS. Sham stimulation mimics all procedures used in active stimulation.
Other: Sham (placebo) tACS
Participants will receive active IAF-tACS delivered at the participant's individual alpha frequency, as measured by EEG. 2mA will be delivered at Cz, and 1 mA (antiphase) split between F3/F4 (in phase). IAF-tACS is delivered in 4 x blocks of 10 min, separated by 2 min HD-EEG.
Other: IAF-tACS
Participants will receive active PandA-tACS delivered with the participant's flatter aperiodic slope, as measured by EEG. 2mA will be delivered at Cz, and 1 mA (antiphase) split between F3/F4 (in phase). PandA-tACS is delivered in 4 x blocks of 10 min, separated by 2 min HD-EEG.
Other: PandA-tACS
Participants will be fitted with the same electrode setup and receive sham (placebo) tACS delivered using the neuroConn DC Stimulator MC.
Participants will be fitted with the same electrode setup and receive IAF-tACS delivered using the neuroConn DC Stimulator MC.
Participants will be fitted with the same electrode setup and receive PandA-tACS delivered using the neuroConn DC Stimulator MC.
Safety via the presence of any serious AEs
The number of serious adverse events (SAEs) deemed at least potentially related to PandA-tACS.
Time frame: Day 1 to within 90 days of expected delivery date.
Tolerability of PandA-tACS
Proportion of participants reporting stimulation intolerance or unable to complete stimulation due to tolerability.
Time frame: Immediately after intervention
Feasibility of PandA-tACS
Total number of enrolled participants. Must be at least 45 overall, and 15 per group.
Time frame: Through completion of the study, roughly 2 years
Change in aperiodic slope in the dlPFC region.
Pre- to post-stimulation change in left dorsolateral prefrontal cortex (dlPFC) aperiodic slope (beta coefficient/exponent) derived from resting high-density (HD-EEG). The endpoint will be compared for PandA-tACS versus IAF-tACS and sham.
Time frame: Immediately before and after 40 minutes of stimulation (on single interventional session day).
Correlation between modeled left dorsolateral prefrontal cortex (dlPFC) electric field strength and pre- to post-stimulation change in left dlPFC aperiodic slope
Within the PandA-tACS group, correlation between modeled left dlPFC electric field strength and pre- to post-stimulation change in left dlPFC aperiodic slope.
Time frame: Immediately before and after 40 minutes of stimulation (on single interventional session day).
Plan to share: Yes — This study will collect 128-channel high-density electroencephalography (HD-EEG) data, clinician and self-report assessments relating to depression and other mood symptoms, diagnostic interviews relating to psychiatric disorders, medical chart information including current and past medical history in relation to general medical history, pregnancy and birth outcome information, and psychiatric history; anatomical MRI data, intervention experience questionnaires including tolerability and blinding questionnaires, demographic data, blood pressure at each intervention visit, and daily self-reported prenatal symptoms. The investigators will share de-identified HD-EEG, MRI, safety, feasibility, and tolerability data, symptom ratings, intervention experience questionnaires, demographic data, blood pressure and pre-natal symptoms. Data will be available on the NIMH Data Archive (NDA) per NIMH policies, and also the Open Science Framework (open source) labelled under the appropriate NCT number.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Research participant data (e.g., demographics [age, sex], symptom ratings [DSM-5 Cross Cutting Symptom Measure, WHODAS, GAD-7, PHQ-9], blood pressure, pre-natal symptoms, intervention experience questionnaires, safety, feasibility, and tolerability data) on a 6-month schedule starting one year after receipt of award as required by the NDA. MRI imaging data, and raw and pre-processed electroencephalography data will be shared upon completion of the award. Code created as part of this award will be uploaded to GitHub upon relevant publication. The NIMH NDA has standard processes in place for the request of data use and will arbitrate which requests to allow. The scientific data will be made available for at least as long as required by applicable data repository policies.
Access criteria: Data will be findable and identifiable through the NDA Collection associated with this award. NDA collections have digital object identifiers (DOIs), making them easy to locate. The investigators will upload a data dictionary alongside relevant data. Code created as part of this award will be uploaded to GitHub upon relevant publication
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jun 2028, 19 months later.
Of 151 non-industry interventional studies with no phase under Mood Disorders, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 19 months is below that.
Counting every sponsor, half of 162 studies reached it within 21 months; a quarter within 11 and three quarters within 44.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, on Nov 3, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
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 ↗
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