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

NCT07217223 | Recruiting FDA Device

• 1 other identifier: 812687
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

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

Keywords

Treatment; Treatment Resistant Depression; Major Depressive Disorder; MDD

Outcome Measures

Primary Outcomes (5)

• Feasibility (Recruitment)

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

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

• Feasibility (Retention)

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

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

• Feasibility (Adherence)

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

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

• Safety of at-home spaced tDCS

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

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

• Tolerability to spaced tDCS

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

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

Secondary Outcomes (7)

• Changes from pre-treatment depressive symptomatology in post-treatment

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

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

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

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

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

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

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

• Biomarker Discovery: TMS-Evoked Potential (TEP) Component Amplitudes via TMS-EEG

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

Study Arms (1)

Spaced Transcranial Direct Current Stimulation Treatment

EXPERIMENTAL

tDCS, 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

Device: Spaced Transcranial Direct Current Stimulation (tDCS)

Interventions

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.

Spaced Transcranial Direct Current Stimulation Treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Interventional Psychiatry

San Diego, California, 92127, United States

RECRUITING

Related Publications (12)

• 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.

  PMID: 29877965 BACKGROUND

• 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.

  PMID: 29415152 BACKGROUND

• 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.

  PMID: 23389323 BACKGROUND

• 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.

  PMID: 28657871 BACKGROUND

• 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.

  PMID: 20434997 BACKGROUND

• 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.

  PMID: 36801903 BACKGROUND

• 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.

  PMID: 10990547 BACKGROUND

• 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.

  PMID: 35839661 BACKGROUND

• 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.

  PMID: 39433921 BACKGROUND

• 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.

  PMID: 29213226 BACKGROUND

• 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.

  PMID: 39327744 BACKGROUND

• 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.

  PMID: 39876681 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Interventional Psychiatry

CONTACT

858-966-5832; iptrials@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 15, 2025
• Study Start: September 27, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 9, 2026

Record last verified: 2025-08

Locations

US (1)