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.
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.
History of psychotic or bipolar disorder or depression with psychotic features;
Significant borderline personality disorder;
Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal;
Clinically significant suicidality disorder;
Single group
Spaced Transcranial Direct Current Stimulation (tDCS)
DevicetDCS 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.
Feasibility (Recruitment)
Recruitment rate will be measured as the number of patients enrolled by the conclusion of the study, reported as a whole number.
Feasibility (Retention)
Retention rate will be measured as the percentage of enrolled patients who complete all study visits, reported as a percentage.
Feasibility (Adherence)
The proportion of completed sessions relative to the total prescribed sessions, expressed as a percentage.
Safety of at-home spaced tDCS
Safety will be measured by the number of serious adverse events (SAEs)
Changes from pre-treatment depressive symptomatology in post-treatment
Changes in depressive symptoms will be assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), which ranges from 0 to 60, with higher scores indicating more severe depression. A decrease in the MADRS score will be interpreted as an improvement in symptoms.
Biomarker Discovery: Short-Interval Intracortical Inhibition (SICI) via TMS-EMG
TMS-EMG will be used to evaluate changes in SICI.
Biomarker Discovery: Intracortical Facilitation (ICF) via TMS-EMG
TMS-EMG will be used to evaluate changes in intracortical facilitation
Biomarker Discovery: Cortical Silent Period (CSP) via Transcranial Magnetic Stimulation-Electromyography (TMS-EMG)
TMS-EMG will be used to assess changes in the cortical silent period (CSP). Unit of Measurement: Duration (milliseconds).
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