This study aims to evaluate the clinical efficacy and neurophysiological mechanisms of home-based spaced tDCS in TRD through a randomized, double-blind, sham-controlled trial conducted under remote supervision. Specifically, this trial will: (1) compare the efficacy of active versus sham spaced tDCS on depressive symptom severity in individuals with TRD and (2) characterize neurophysiological changes associated with spaced tDCS using TMS-EEG, TMS-EMG and resting state EEG.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
74
Spaced-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).
Soterix Medical mini-CT device sham protocol that match real stimulation parameters will be used.
UCSD Interventional Psychiatry
San Diego, California, United States
Active vs Sham spaced tDCS Efficacy as measured by the Montgomery-Åsberg Depression Rating Scale
To compare the efficacy of active versus sham spaced tDCS in reducing depressive symptom severity in TRD. Symptom severity will be measured using the MADRS score at four weeks post-treatment.
Time frame: Baseline to 4-weeks post treatment
Changes in MADRS with active versus sham spaced tDCS during all post treatment visits
Clinical outcomes associated with active versus sham spaced tDCS as measured by MADRS response (≥50% reduction) and remission (score ≤10) rates.
Time frame: 1-week post treatment to 10-week post treatment
Changes in Hamilton Depression Rating Scale, 17-item version scores
Reduction in HAMD-17 scores at all follow-up timepoints. Score range from 0 to 52.
Time frame: 1-week post treatment to 10-week post treatment
Changes in Patient Health Questionnaire-9
Changes in PHQ scores at all follow-up timepoints. With scores ranging from 0-27
Time frame: 1-week post treatment to 10-week post treatment
Changes in General Anxiety Disorder-7
Changes in GAD-7 scores at all follow-up timepoints. Score range from 0-21
Time frame: 1-week post treatment to 10-week post treatment
Changes in The Modified Scale for Suicidal Ideation
Changes in the presence and severity of suicidal thoughts at all follow-up timepoints. Scores ranging from 0-54
Time frame: 1-week post treatment to 10-week post treatment
Feasibility (Recruitment)
Recruitment rate will be measured as the number of patients enrolled by the conclusion of the study, reported as a whole number.
Time frame: Baseline clinical assessment to 10 weeks post treatment.
Feasibility (Retention)
Retention rate will be measured as the percentage of enrolled patients who complete all study visits, reported as a percentage.
Time frame: Baseline clinical assessment to 10 weeks post treatment.
Feasibility (Adherence)
The proportion of completed sessions relative to the total prescribed sessions, expressed as a percentage.
Time frame: Baseline clinical assessment to 10 weeks post treatment
Safety of at-home spaced tDCS
Safety will be measured by the number of serious adverse events (SAEs)
Time frame: Baseline clinical assessment to 10 weeks post treatment
Tolerability to spaced tDCS
Tolerability will be measured by the number of adverse events (AEs).
Time frame: Baseline clinical assessment to 10 weeks post treatment.
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