Heart Rate Variability (HRV)-Guided Transcranial Direct Current Stimulation (tDCS)
This technology development project will be informed and guided by initial data collection of human subject data. For this purpose, the investigators will recruit n=100 people with mild to moderate depression in a double-blinded, parallel-arm, sham-controlled data collection period administered at home and using the in
| Condition(s) | Depression |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This technology development project will be informed and guided by initial data collection of human subject data. For this purpose, the investigators will recruit n=100 people with mild to moderate depression in a double-blinded, parallel-arm, sham-controlled data collection period administered at home and using the investigator's remotely supervised (RS) tDCS protocol. Enrolled participants will complete 10 days of 30-minute tDCS (2.0, DLPFC left anodal) using the RS-tDCS protocol. During each daily session, standard HR and impedance-based HR (i-HR), obtained from the tDCS headset, will be collected to identify a possible marker of response to tDCS in depression. Participants will be randomized 2:1 to active vs. sham tDCS. |
| Who can participate | Inclusion Criteria: * Mild to moderate depression (Beck Depression Inventory(BDI)-II 14-28) * Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-V-TR) Depressive episode * Wide Range Achievement Test (WRAT)-4th Reading Recognition subtest standard score \>85 Exclusion Criteria: * Primary neurologic, psychiatric (e.g., multiple sclerosis, stroke, Parkinson's disease, spinal cord injury, intracranial mass, traumatic brain injury (TBI), epilepsy, mild cognitive impairment (MCI), or dementia), or major medical disorder (e.g., history of myocardial infarction, diabetes, thyroid disease, arrhythmia, atrial fibrillation) (medical history review) * DSM-V-TR bipolar depression, psychotic disorder, or alcohol or substance use disorder (M.I.N.I.) * Active or high |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | NYU Langone Health |
| Locations | New York, New York, United States |
| Start date | 2025-01-02 |
| NCT ID | NCT06455527 |
| Official listing | https://clinicaltrials.gov/study/NCT06455527 |