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.
People between the ages of 18 and 70 at the time of screening.
Able to read, understand, and provide written, dated informed consent prior to screening. Proficiency in English sufficient to complete questionnaires / follow instructions during interventions. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information.
Currently diagnosed with Major Depressive Disorder (MDD) and meets criteria for a Major Depressive Episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5).
Medical records confirming a history of at least moderate treatment-resistance as defined on Antidepressant Treatment History Form (ATHF) score for that antidepressant trial of > 2 in the current episode OR have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF score of 1 or 2 on those 2 separate antidepressants) OR have a combination of one failed trial and one not tolerated trial, per the definitions above.
Pregnancy this includes breastfeeding or trying to becoming pregnant.
History of psychotic or bipolar disorder or depression with psychotic features.
Significant borderline personality disorder.
Significant comorbid obsessive-compulsive or post-traumatic stress disorder.
Parallel
Spaced Transcranial Direct Current Stimulation (tDCS)
DeviceSpaced-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).
Sham Spaced tDCS
DeviceSoterix Medical mini-CT device sham protocol that match real stimulation parameters will be used.
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.
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.
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.
Changes in Patient Health Questionnaire-9
Changes in PHQ scores at all follow-up timepoints. With scores ranging from 0-27
Changes in General Anxiety Disorder-7
Changes in GAD-7 scores at all follow-up timepoints. Score range from 0-21
Biomarker Discovery: Short-Interval Intracortical Inhibition (SICI) and Long-Interval Intracortical Inhibition (LICI) via TMS-EMG
TMS-EMG will be used to evaluate changes in SICI and LICI.
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).
TMS-Evoked Potential (TEP) Component Amplitudes via TMS-EEG
TMS-EEG will be used to evaluate changes in TMS-evoked potential (TEP) component amplitudes. Unit of Measurement: Voltage (µV).
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University of California, San Diego
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
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