RecruitingNot ApplicableNCT07217223

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

Sponsor

University of California, San Diego

Enrollment

10 participants

Start Date

Sep 27, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a home-based brain stimulation device called tDCS (transcranial direct current stimulation) for people with treatment-resistant depression — meaning their depression has not improved with antidepressant medications. The device delivers a very mild electrical current to the scalp and is used at home during scheduled sessions. **You may be eligible if...** - You are between 18 and 85 years old - You have been diagnosed with Major Depressive Disorder (MDD) with moderate-to-severe symptoms - You have tried at least two antidepressant medications without sufficient relief - You have a stable internet connection and a device compatible with Microsoft Teams **You may NOT be eligible if...** - You have a history of bipolar disorder, psychosis, or depression with psychotic features - You have a significant obsessive-compulsive or PTSD diagnosis - You have a current moderate or severe substance use disorder - You have a history of seizures, brain tumors, multiple sclerosis, Parkinson's, or significant head trauma - You are pregnant or breastfeeding - Your depression has lasted continuously for more than 5 years - You have a significant suicidal plan and intent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESpaced Transcranial Direct Current Stimulation (tDCS)

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.