Physiology of Transcranial Direct Current Stimulation.
Charlotte J Stagg, Andrea Antal, Michael A Nitsche
https://pubmed.ncbi.nlm.nih.gov/29877965Actively Recruiting
Phase Not Applicable
Age: 18Years - 85Years
All Genders
ID07217223
Spaced Transcranial Direct Current Stimulation for Treatment-Resistant Depression: A Home-Based Feasibility and Safety Study
Led by University of California, San Diego · Updated on 2026-01-09
10
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness, safety, tolerability, and feasibility of at-home transcranial direct current stimulation (tDCS) as a treatment for depression, especially for patients who have not responded well to traditional therapies. This study focuses on treatment-resistant depression and major depressive disorder, aiming to understand changes in mood, brain activity, and clinical outcomes through this novel approach. The study is open-label and involves direct remote supervision during treatment. Treatment consists of self-administered tDCS sessions at home using the Soterix Medical mini-CT device. Participants will receive five tDCS sessions daily on weekdays over a two-week period. Each session lasts 20 minutes with approximately 20-minute breaks between sessions, totaling three hours of stimulation per day. The device delivers low-intensity electrical stimulation at 2 mA with gradual ramp-up and ramp-down phases. Additionally, there will be four in-person appointments required in San Diego, California. Participants will be monitored through pre- and post-treatment neurophysiological biomarker sessions, including measurements such as TMS-EMG and resting-state EEG. Researchers will assess feasibility aspects like recruitment, retention, adherence, and safety over a 12-week period following treatment. The study will also track changes in depressive symptoms and brain activity to inform future research. Participants can expect clinical assessments, remote supervision, and scheduled in-person visits during their involvement, which lasts from baseline until 12 weeks post-treatment.
CONDITIONS
Brief Title
Spaced Transcranial Direct Current Stimulation for Treatment-Resistant Depression: A Home-Based Feasibility and Safety Study
Who Can Participate
Age: 18Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- 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 60 20.
- Safe for TMS as measured 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 by an Antidepressant Treatment History Form (ATHF) score 60 3 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 will not qualify if you...
- History of psychotic or bipolar disorder or depression with psychotic features.
- Significant borderline personality disorder.
- Significant comorbid obsessive-compulsive or post-traumatic stress disorder.
- Current moderate or severe substance use disorder or signs of acute substance withdrawal.
- Clinically significant suicidality.
- Chronic depression lasting over 5 years.
- Pregnancy or lactation, or lack of adequate birth control in women of childbearing age.
- History of significant neurologic disease such as dementia, Parkinson's or Huntington's disease, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or 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 (more than 15 sessions) without meaningful response; history of ketamine (more than 4 sessions) without meaningful response.
- Requirement of benzodiazepine doses greater than lorazepam 2 mg/day.
- Dermatological conditions that contraindicate tDCS.
- Non-correctable sensory impairments.
- Inability to consent or participate as an outpatient.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Duration as per treatment schedule
Participants self-administer transcranial direct current stimulation (tDCS) at home under remote supervision of a trained clinical research coordinator. Each treatment day involves five 20-minute tDCS sessions spaced by approximately 20-minute intervals, lasting about three hours per day.
Remote supervision sessions throughout treatment
Follow-up
Duration - Up to 12 weeks after last treatment
Participants are monitored for safety, tolerability, and clinical outcomes for up to 12 weeks after the last treatment session.
Follow-up visits as scheduled
Trial Site Locations
Total: 1 location
1
UCSD Interventional Psychiatry
San Diego, California, United States, 92127
Actively Recruiting
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Research Team
I
Interventional Psychiatry
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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