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Treatment Resistant Depression (TRD)NCT07217223

Spaced Transcranial Direct Current Stimulation for Treatment-Resistant Depression: A Home-Based Feasibility and Safety Study

A study testing Spaced Transcranial Direct Current Stimulation (tDCS) in people with Treatment Resistant Depression (TRD) and Major Depressive Disorder (MDD), run by University of California, San Diego at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The investigators propose a single-arm, open-label study to evaluate the effectiveness, safety, tolerability and feasibility of at-home transcranial direct current stimulation (tDCS) as a treatment for depression, particularly in cases where patients have not responded well to traditional therapies. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Spaced Transcranial Direct Current Stimulation (tDCS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
27 Sep 2025to 1 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • People between the ages of 18 and 85 at the time of screening.
  • Currently diagnosed with Major Depressive Disorder (MDD) as measured by the MINI and a MADRS score of ≥ 20.
  • Safe for TMS as measures by the TMS Adult Safety Screening (TASS).
  • Medical records confirming a history of failing to achieve clinical response to an adequate antidepressant trial as defined an Antidepressant Treatment History Form (ATHF) score ≥ 3 or ) or shown intolerance to at least two inadequate trials (score 1 or 2), without psychiatric illness due to a general medical condition.
  • Stable internet connection and a device compatible with Microsoft Teams.

Who cannot join

  • History of psychotic or bipolar disorder or depression with psychotic features;
  • Significant borderline personality disorder;
  • Significant comorbid obsessive-compulsive or post-traumatic stress:
  • Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal;
  • Clinically significant suicidality disorder;
  • Chronic depression (defined as of over 5 years duration);
Show all 15Show fewer
  • Pregnancy or lactation, lack of adequate birth control in women of childbearing age;
  • 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;
  • Unstable medical illness;
  • Contraindication to receiving tDCS (e.g., ferromagnetic implant, history of seizure, known brain lesion);
  • History of TMS (greater than 15 sessions) without a clinically meaningful response.; History of ketamine (greater than 4 sessions) without a clinically meaningful response;
  • Require a benzodiazepine with a dose > lorazepam 2 mg/day;
  • dermatological conditions contraindicating tDCS;
  • Non-correctable sensory impairments;
  • Inability to consent or participate as an outpatient

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Interventional Psychiatry contact

858-966-5832

iptrials@health.ucsd.edu

United States1 site, 1 recruiting

  • UCSD Interventional Psychiatry

    San Diego, California, 92127

    Edith Jimenez, 858-657-6149, iptrials@health.ucsd.edu

    UCSD Interventional Psychiatry Clinic, (858)207-0938, iptrials@health.ucsd.edu

    Recruiting

Other trials in United States

About this study

The investigators propose a single-arm, open-label study to evaluate the effectiveness, safety, tolerability and feasibility of at-home transcranial direct current stimulation (tDCS) as a treatment for depression, particularly in cases where patients have not responded well to traditional therapies. Treatment will be delivered over a 2-week period with daily weekday treatments i.e., five tDCS sessions, each lasting 20 minutes, spaced by approximately 20-minute inter-session intervals, for a total of three hours a day. Participants will self-administer treatment at home under direct remote supervision. Pre- and post- treatment neurophysiological biomarkers sessions will also be carried out. The study aims to examine changes in mood, brain activity, and related clinical outcomes before, during, and after treatment, with the goal to provide more information that can be used for future studies.

PLEASE NOTE: THERE WILL BE 4 APPOINTMENTS THAT MUST OCCUR IN PERSON IN SAN DIEGO, CA.

Being tested
Spaced Transcranial Direct Current Stimulation (tDCS)
Keywords
Treatment, Treatment Resistant Depression, Major Depressive Disorder, MDD
Medical subject headings
Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spaced Transcranial Direct Current Stimulation (tDCS)Device

    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).The device is designed for safe, remote tDCS delivery. Participants will be treated using a stimulation at 2 mA, with a 30-second ramp-up and ramp-down phase.

Study groups in NCT07217223
Study groupRoleWhat they receive
Spaced Transcranial Direct Current Stimulation TreatmentExperimentaltDCS, a non-invasive neuromodulation technique that applies low-intensity, direct electrical stimulation to the cortex via scalp electrodes, has been extensively researched as a potential treatment for MDD. tDCS enhances neuroplasticity, which is theorized to be responsible for its therapeutic effects and has been presented as a cost-effective solution for MDD. Preclinical evidence supports the potential advantage of spaced stimulation with tDCS to maximally engage neuroplasticity. tDCS sessions will be self-administered at home under the supervision of a trained clinical research coordinator. Each treatment day will consist of five tDCS sessions, each lasting 20 minutes, spaced by approximately 20-minute inter-session intervals, for a total of three hours per day. Other Names: * tDCS * Soterix Medical miniCT
Receives: Device: Spaced Transcranial Direct Current Stimulation (tDCS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility (Recruitment)

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

    Measured: From baseline clinical assessment prior to treatment to 12 weeks after last treatment.

  2. Feasibility (Retention)

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

    Measured: From baseline clinical assessment prior to treatment, to 12 weeks after last treatment.

  3. Feasibility (Adherence)

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

    Measured: From baseline clinical assessment prior to treatment, to 12 weeks after last treatment.

  4. Safety of at-home spaced tDCS

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

    Measured: From baseline clinical assessment prior to treatment, to 12 weeks after last treatment.

  5. Tolerability to spaced tDCS

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

    Measured: From baseline clinical assessment prior to treatment, to 12 weeks after last treatment.

Secondary outcomes (7)

  1. Changes from pre-treatment depressive symptomatology in post-treatment

    Changes in depressive symptoms will be assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), which ranges from 0 to 60, with higher scores indicating more severe depression. A decrease in the MADRS score will be interpreted as an improvement in symptoms.

    Measured: From baseline clinical assessment prior to treatment, to 12 weeks after last treatment.

  2. Biomarker Discovery: Short-Interval Intracortical Inhibition (SICI) via TMS-EMG

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

    Measured: From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment.

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

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

    Measured: From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment.

  4. 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).

    Measured: From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment.

  5. Biomarker Discovery: 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).

    Measured: From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment.

  6. Biomarker Discovery: Resting-State Electroencephalography (rsEEG)

    rsEEG will be used to analyze changes in brain activity patterns at rest.

    Unit of Measurement: Frequency (Hz)

    Measured: From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment.

  7. Biomarker Discovery: Resting-State Electroencephalography (rsEEG)

    rsEEG will be used to analyze changes in brain activity patterns at rest.

    Unit of Measurement: Amplitude (µV).

    Measured: From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2025
  2. Study start27 Sep 2025
  3. Primary completion7 Oct 2026 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07217223
Sponsor's protocol ID
812687
Other IDs
812687
Status last verified
Sep 2026
First submitted
30 Sep 2025
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Stagg CJ, Antal A, Nitsche MA. Physiology of Transcranial Direct Current Stimulation. J ECT. 2018 Sep;34(3):144-152. doi: 10.1097/YCT.0000000000000510.

    PubMed 29877965

  • Williams NR, Sudheimer KD, Bentzley BS, Pannu J, Stimpson KH, Duvio D, Cherian K, Hawkins J, Scherrer KH, Vyssoki B, DeSouza D, Raj KS, Keller J, Schatzberg AF. High-dose spaced theta-burst TMS as a rapid-acting antidepressant in highly refractory depression. Brain. 2018 Mar 1;141(3):e18. doi: 10.1093/brain/awx379. No abstract available.

    PubMed 29415152

  • Brunoni AR, Valiengo L, Baccaro A, Zanao TA, de Oliveira JF, Goulart A, Boggio PS, Lotufo PA, Bensenor IM, Fregni F. The sertraline vs. electrical current therapy for treating depression clinical study: results from a factorial, randomized, controlled trial. JAMA Psychiatry. 2013 Apr;70(4):383-91. doi: 10.1001/2013.jamapsychiatry.32.

    PubMed 23389323

  • Brunoni AR, Moffa AH, Sampaio-Junior B, Borrione L, Moreno ML, Fernandes RA, Veronezi BP, Nogueira BS, Aparicio LVM, Razza LB, Chamorro R, Tort LC, Fraguas R, Lotufo PA, Gattaz WF, Fregni F, Bensenor IM; ELECT-TDCS Investigators. Trial of Electrical Direct-Current Therapy versus Escitalopram for Depression. N Engl J Med. 2017 Jun 29;376(26):2523-2533. doi: 10.1056/NEJMoa1612999.

    PubMed 28657871

  • Fritsch B, Reis J, Martinowich K, Schambra HM, Ji Y, Cohen LG, Lu B. Direct current stimulation promotes BDNF-dependent synaptic plasticity: potential implications for motor learning. Neuron. 2010 Apr 29;66(2):198-204. doi: 10.1016/j.neuron.2010.03.035.

    PubMed 20434997

  • Jog MA, Anderson C, Kubicki A, Boucher M, Leaver A, Hellemann G, Iacoboni M, Woods R, Narr K. Transcranial direct current stimulation (tDCS) in depression induces structural plasticity. Sci Rep. 2023 Feb 17;13(1):2841. doi: 10.1038/s41598-023-29792-6.

    PubMed 36801903

  • Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.

    PubMed 10990547

  • 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

  • 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

  • Thair H, Holloway AL, Newport R, Smith AD. Transcranial Direct Current Stimulation (tDCS): A Beginner's Guide for Design and Implementation. Front Neurosci. 2017 Nov 22;11:641. doi: 10.3389/fnins.2017.00641. eCollection 2017.

    PubMed 29213226

  • Vogelmann U, Pilloni G, Brunoni AR, Charvet L. How can we develop transcranial direct current stimulation into an effective at-home treatment tool for depression? Expert Rev Med Devices. 2024 Oct;21(10):883-886. doi: 10.1080/17434440.2024.2409767. Epub 2024 Sep 26. No abstract available.

    PubMed 39327744

  • Couture M, Desbeaumes Jodoin V, Bousseau E, Sarshoghi A, Nitsche MA, Blumberger DM, Bolduc C, Weissman CR, Appelbaum LG, Daskalakis ZJ, Poorganji M, Lesperance P, Miron JP. Spaced Transcranial Direct Current Stimulation for Major Depression. Am J Psychiatry. 2025 Mar 1;182(3):276-284. doi: 10.1176/appi.ajp.20240083. Epub 2025 Jan 29.

    PubMed 39876681

Questions about this trial

What is this clinical trial studying?

A study testing Spaced Transcranial Direct Current Stimulation (tDCS) in people with Treatment Resistant Depression (TRD) and Major Depressive Disorder (MDD), run by University of California, San Diego at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Interventional Psychiatry (858-966-5832, iptrials@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility (Recruitment) (time frame: From baseline clinical assessment prior to treatment to 12 weeks after last treatment.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07217223, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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