ClinicalTrials.gg
Not yet recruitingNCT07834762Updated Sep 22, 2026

Home-Based Randomized Trial of Spaced Transcranial Direct Current Stimulation for Treatment-Resistant Depression

An interventional study of Spaced Transcranial Direct Current Stimulation (tDCS) and Sham Spaced tDCS in Treatment Resistant Depression (TRD) and Major Depressive Disorder (MDD), sponsored by University of California, San Diego. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 204 studies in Depressive Disorder, Treatment-Resistant with a site in United States — 43 open to participants now, 65 under way, 6 of them phase 3. Depressive Disorder, Treatment-Resistant · United States.

Planned enrollment
63rd of 181
74 · median 38
Started
2026
with 18 others
No phase
72 of 204
21 open now
Primary completion
2031-10
later than 60 of 64 live
Registered
202nd of 204
by date
Lead sponsor
7 of 204
University of California, San Diego

Among the 204 studies in Depressive Disorder, Treatment-Resistant with a site in United States, this one is the 63rd largest by planned enrollment of the 181 interventional ones that give a count, is one of 19 that started in 2026, is one of 72 with no phase, reaches primary completion later than 60 of the 64 other live ones, and was the 202nd registered.

Depressive Disorder, Treatment-Resistant

448 studies on the registry are indexed under Depressive Disorder, Treatment-Resistant; 147 are open to participants now.

Browse Depressive Disorder, Treatment-Resistant studies →

Open to participants now

43 of the 204 studies in Depressive Disorder, Treatment-Resistant with a site in United States are open now. Recruiting first, the newest first:

38 more — sign in →

All 43 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 114 Depressive Disorder, Treatment-Resistant studies recruiting now, 26 (23%) set no upper age limit and 76 (67%) stop at 75 or younger; 1 takes children under 18; 13 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

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02

Study summary

This study aims to evaluate the clinical efficacy and neurophysiological mechanisms of home-based spaced tDCS in TRD through a randomized, double-blind, sham-controlled trial conducted under remote supervision. Specifically, this trial will: (1) compare the efficacy of active versus sham spaced tDCS on depressive symptom severity in individuals with TRD and (2) characterize neurophysiological changes associated with spaced tDCS using TMS-EEG, TMS-EMG and resting state EEG.

03

Conditions studied

  • Treatment Resistant Depression (TRD)
  • Major Depressive Disorder (MDD)

Keywords

  • tDCS
  • Treatment Resistant Depression
  • Major Depressive Disorder
  • MDD
  • transcranial direct current stimulation
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

  • People between the ages of 18 and 70 at the time of screening.
  • Able to read, understand, and provide written, dated prior to screening. Proficiency in English sufficient to complete questionnaires / follow instructions during interventions. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other information.
  • Currently diagnosed with Major Depressive Disorder (MDD) and meets criteria for a Major Depressive Episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision ().
  • Medical records confirming a history of at least moderate treatment-resistance as defined on Antidepressant Treatment History Form (ATHF) score for that antidepressant trial of > 2 in the current episode OR have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF score of 1 or 2 on those 2 separate antidepressants) OR have a combination of one failed trial and one not tolerated trial, per the definitions above.
  • MADRS score of ≥20 at screening.
  • Existing relationship with mental health provider and access to ongoing psychiatric care before and after completion of the study.
  • Must be on a stable antidepressant therapeutic regimen for at least 4 weeks prior to study enrollment and agree to continue this regimen throughout the study period. Participants who are not currently on antidepressant treatment are eligible, provided that no discontinuation occurred within the 4 weeks preceding study enrollment.
  • For persons of : use of highly effective for at least 1 month prior to screening and agreement to use such a method during study participation.
  • Agreement to adhere to Lifestyle Considerations (i.e. must continue with any existing treatments) throughout study duration.
  • For persons of childbearing potential: must take a pregnancy test prior to initiating treatment, with results confirmed as negative by study staff
  • Participants will need to have a stable internet connection and a device compatible with UCSD Microsoft Teams or UCSD Zoom to facilitate remote communication and engagement in study activities.

Exclusion criteria

Exclusion Criteria:

  • Pregnancy this includes breastfeeding or trying to becoming pregnant.
  • History of psychotic or bipolar disorder or depression with psychotic features.
  • Significant borderline personality disorder.
  • Significant comorbid obsessive-compulsive or post-traumatic stress disorder.
  • Previously diagnosed Intellectual Disability or Autism Spectrum Disorder.
  • Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal.
  • suicidality.
  • Any history of tDCS.
  • Any history of ECT.
  • History of TMS (greater than 15 sessions) without a clinically meaningful response.
  • History of ketamine (greater than 4 sessions) without a clinically meaningful response.
  • History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma with persistent symptoms.
  • Untreated or insufficiently treated endocrine disorder.
  • to receiving tDCS (e.g., ferromagnetic implant, history of seizure, known brain lesion).
  • Treatment with an drug or other intervention within the study period.
  • Unstable symptoms between screening and baseline as defined by a ≥ 30% change in MADRS score.
  • Require a benzodiazepine with a dose > lorazepam 2 mg/day
  • Has started a new psychotherapeutic process in the past 3 months from screening.
  • Use of potentially irritant topical treatments (ex: retinoids, alpha hydroxy acids).
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.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

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.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
74 participants (estimated)

Study arms

  • Active comparator
    Active spaced-tDCS

    Active tDCS applies low-intensity electrical current to the scalp to modulate cortical excitability through subthreshold shifts in neuronal membrane potentials, influencing synaptic plasticity

    Device: Spaced Transcranial Direct Current Stimulation (tDCS)

  • Sham comparator
    Sham spaced-tDCS

    Sham tDCS is a placebo control that simulates the physical sensations of tDCS but does not deliver any actual, prolonged electrical current to the brain.

    Device: Sham Spaced tDCS

Interventions

  • DeviceSpaced Transcranial Direct Current Stimulation (tDCS)

    Spaced-tDCS will be self-administered at home under the supervision of a trained clinical research coordinator using the Soterix Medical mini-CT device with remote monitoring via a secure videoconferencing platform (e.g., Microsoft Teams).

  • DeviceSham Spaced tDCS

    Soterix Medical mini-CT device sham protocol that match real stimulation parameters will be used.

06

What researchers measure

Primary outcomes

  1. Active vs Sham spaced tDCS Efficacy as measured by the Montgomery-Åsberg Depression Rating Scale

    To compare the efficacy of active versus sham spaced tDCS in reducing depressive symptom severity in TRD. Symptom severity will be measured using the MADRS score at four weeks post-treatment.

    Time frame: Baseline to 4-weeks post treatment

Secondary outcomes

  1. Changes in MADRS with active versus sham spaced tDCS during all post treatment visits

    Clinical outcomes associated with active versus sham spaced tDCS as measured by MADRS response (≥50% reduction) and remission (score ≤10) rates.

    Time frame: 1-week post treatment to 10-week post treatment

  2. Changes in Hamilton Depression Rating Scale, 17-item version scores

    Reduction in HAMD-17 scores at all follow-up timepoints. Score range from 0 to 52.

    Time frame: 1-week post treatment to 10-week post treatment

  3. Changes in Patient Health Questionnaire-9

    Changes in PHQ scores at all follow-up timepoints. With scores ranging from 0-27

    Time frame: 1-week post treatment to 10-week post treatment

  4. Changes in General Anxiety Disorder-7

    Changes in GAD-7 scores at all follow-up timepoints. Score range from 0-21

    Time frame: 1-week post treatment to 10-week post treatment

  5. Changes in The Modified Scale for Suicidal Ideation

    Changes in the presence and severity of suicidal thoughts at all follow-up timepoints. Scores ranging from 0-54

    Time frame: 1-week post treatment to 10-week post treatment

  6. Feasibility (Recruitment)

    Recruitment rate will be measured as the number of patients enrolled by the conclusion of the study, reported as a whole number.

    Time frame: Baseline clinical assessment to 10 weeks post treatment.

  7. Feasibility (Retention)

    Retention rate will be measured as the percentage of enrolled patients who complete all study visits, reported as a percentage.

    Time frame: Baseline clinical assessment to 10 weeks post treatment.

  8. Feasibility (Adherence)

    The proportion of completed sessions relative to the total prescribed sessions, expressed as a percentage.

    Time frame: Baseline clinical assessment to 10 weeks post treatment

  9. Safety of at-home spaced tDCS

    Safety will be measured by the number of serious adverse events (SAEs)

    Time frame: Baseline clinical assessment to 10 weeks post treatment

  10. Tolerability to spaced tDCS

    Tolerability will be measured by the number of adverse events (AEs).

    Time frame: Baseline clinical assessment to 10 weeks post treatment.

Other outcomes

  1. Biomarker Discovery: Short-Interval Intracortical Inhibition (SICI) and Long-Interval Intracortical Inhibition (LICI) via TMS-EMG

    TMS-EMG will be used to evaluate changes in SICI and LICI.

    Time frame: Baseline to 4-weeks post treatment

  2. Biomarker Discovery: Intracortical Facilitation (ICF) via TMS-EMG

    TMS-EMG will be used to evaluate changes in intracortical facilitation

    Time frame: Baseline to 4-weeks post treatment

  3. Biomarker Discovery: Cortical Silent Period (CSP) via Transcranial Magnetic Stimulation-Electromyography (TMS-EMG)

    TMS-EMG will be used to assess changes in the cortical silent period (CSP). Unit of Measurement: Duration (milliseconds).

    Time frame: Baseline to 4-weeks post treatment

  4. TMS-Evoked Potential (TEP) Component Amplitudes via TMS-EEG

    TMS-EEG will be used to evaluate changes in TMS-evoked potential (TEP) component amplitudes. Unit of Measurement: Voltage (µV).

    Time frame: Baseline to 4-weeks post treatment

  5. Resting-State Electroencephalography (rsEEG)

    rsEEG will be used to analyze changes in brain activity patterns at rest. Unit of Measurement: Frequency (Hz)

    Time frame: Baseline to 4-weeks post treatment

07

Study locations

1 site
08

References and documents

Publications

  • Tremblay S, Rogasch NC, Premoli I, Blumberger DM, Casarotto S, Chen R, Di Lazzaro V, Farzan F, Ferrarelli F, Fitzgerald PB, Hui J, Ilmoniemi RJ, Kimiskidis VK, Kugiumtzis D, Lioumis P, Pascual-Leone A, Pellicciari MC, Rajji T, Thut G, Zomorrodi R, Ziemann U, Daskalakis ZJ. Clinical utility and prospective of TMS-EEG. Clin Neurophysiol. 2019 May;130(5):802-844. doi: 10.1016/j.clinph.2019.01.001. Epub 2019 Jan 19. PubMed 30772238 ↗
  • Woodham RD, Rimmer RM, Young AH, Fu CHY. Adjunctive home-based transcranial direct current stimulation treatment for major depression with real-time remote supervision: An open-label, single-arm feasibility study with long term outcomes. J Psychiatr Res. 2022 Sep;153:197-205. doi: 10.1016/j.jpsychires.2022.07.026. Epub 2022 Jul 8. PubMed 35839661 ↗
  • Borrione L, Cavendish BA, Aparicio LVM, Luethi MS, Goerigk S, Ramos MRF, Moran NKS, Carneiro AM, Valiengo L, Moura DO, de Souza JP, Batista MP, Aparecida da Silva V, Klein I, Suen P, Gallucci-Neto J, Padberg F, Razza LB, Vanderhasselt MA, Lotufo PA, Bensenor IM, Fregni F, Brunoni AR. Home-Use Transcranial Direct Current Stimulation for the Treatment of a Major Depressive Episode: A Randomized Clinical Trial. JAMA Psychiatry. 2024 Apr 1;81(4):329-337. doi: 10.1001/jamapsychiatry.2023.4948. PubMed 38170541 ↗
  • Woodham RD, Selvaraj S, Lajmi N, Hobday H, Sheehan G, Ghazi-Noori AR, Lagerberg PJ, Rizvi M, Kwon SS, Orhii P, Maislin D, Hernandez L, Machado-Vieira R, Soares JC, Young AH, Fu CHY. Home-based transcranial direct current stimulation treatment for major depressive disorder: a fully remote phase 2 randomized sham-controlled trial. Nat Med. 2025 Jan;31(1):87-95. doi: 10.1038/s41591-024-03305-y. Epub 2024 Oct 21. PubMed 39433921 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2031, 60 months later.

Of 136 non-industry interventional studies with no phase under Depressive Disorder, Treatment-Resistant, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 79. This study's planned 60 months is above that.

Counting every sponsor, half of 140 studies reached it within 50 months; a quarter within 22 and three quarters within 88.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 10, 2026
First posted
Sep 22, 2026
StartEst.
Oct 15, 2026
Primary completionEst.
Oct 15, 2031
CompletionEst.
Oct 15, 2031
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07834762
Responsible party
Jean-Philippe Miron (MD, PhD, University of California, San Diego) — Principal investigator
First posted
Sep 22, 2026
Start date
Oct 15, 2026 (estimated)
Primary completion
Oct 15, 2031 (estimated)
Completion
Oct 15, 2031 (estimated)
Last update
Sep 22, 2026

Study contacts

Interventional Psychiatry
Contact
iptrials@health.ucsd.edu
858-657-6149

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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