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

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT07217223
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Sep 27, 2025
Status verified
Aug 2025
Primary completion
Oct 1, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Spaced Transcranial Direct Current Stimulation Treatment
    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

Primary Outcome Measure

Feasibility (Recruitment) [ Time Frame: From baseline clinical assessment prior to treatment to 12 weeks after last treatment. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCSD Interventional PsychiatrySan DiegoCalifornia92127
Edith Jimenez
[email protected]
858-657-6149
UCSD Interventional Psychiatry Clinic
[email protected]
(858)207-0938

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By research site
UCSD Interventional Psychiatry· San Diego, CA

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