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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether tDCS, which uses a weak electrical current to stimulate the brain, is safe and helps adults whose depression has not improved with treatment. You give yourself treatment at home with live online supervision for about 3 hours each weekday for 2 weeks. You must also attend 4 in-person visits in San Diego, CA.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 85 years old.
  • You have major depression confirmed by a study interview and a depression rating score of at least 20.
  • A safety check shows you can safely receive TMS, a treatment that uses magnets to stimulate the brain.
  • Medical records show that at least one full antidepressant treatment did not help enough, or that you could not tolerate at least two shorter or lower-dose trials.
  • Your mental illness is not caused by a general medical condition.
  • You have reliable internet and a device that works with Microsoft Teams.

Who can't join

  • You have a history of bipolar disorder or psychosis, which can involve seeing or believing things that are not real; or significant borderline personality disorder, obsessive-compulsive disorder, or post-traumatic stress.
  • You have a current moderate or severe alcohol or drug use disorder, sudden withdrawal symptoms, or a serious risk of suicide.
  • Your depression has lasted more than 5 years.
  • You are pregnant or breastfeeding, or can become pregnant but do not use adequate birth control.
  • You have a serious brain or nerve disease, a major head injury with lasting symptoms, or an unstable medical illness.
  • tDCS is unsafe for you because of a magnetic metal implant, past seizures, a known area of brain damage, or a skin condition.
  • You had more than 15 TMS sessions or more than 4 ketamine sessions without enough benefit, or need a benzodiazepine dose higher than 2 mg of lorazepam per day.
  • You have a sight, hearing, or other sensory problem that cannot be corrected, cannot give consent, or cannot take part without staying in a hospital.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. People between the ages of 18 and 85 at the time of screening. 2. Currently diagnosed with Major Depressive Disorder (MDD) as measured by the MINI and a MADRS score of ≥ 20. 3. Safe for TMS as measures by the TMS Adult Safety Screening (TASS). 4. 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. 5. Stable internet connection and a device compatible with Microsoft Teams. Exclusion Criteria: 1. History of psychotic or bipolar disorder or depression with psychotic features; 2. Significant borderline personality disorder; 3. Significant comorbid obsessive-compulsive or post-traumatic stress: 4. Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal; 5. Clinically significant suicidality disorder; 6. Chronic depression (defined as of over 5 years duration); 7. Pregnancy or lactation, lack of adequate birth control in women of childbearing age; 8. 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; 9. Unstable medical illness; 10. Contraindication to receiving tDCS (e.g., ferromagnetic implant, history of seizure, known brain lesion); 11. History of TMS (greater than 15 sessions) without a clinically meaningful response.; History of ketamine (greater than 4 sessions) without a clinically meaningful response; 12. Require a benzodiazepine with a dose \> lorazepam 2 mg/day; 13. dermatological conditions contraindicating tDCS; 14. Non-correctable sensory impairments; 15. Inability to consent or participate as an outpatient

Study sites (1)

CA