RecruitingNot ApplicableNCT06455527

Heart Rate Variability (HRV)-Guided Transcranial Direct Current Stimulation (tDCS)

HRV-Guided tDCS: Integrating A Biomarker For Clinical Utility

Sponsor

NYU Langone Health

Enrollment

100 participants

Start Date

Jan 2, 2025

Study Type

INTERVENTIONAL

Conditions

Depression

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

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 Criteria10

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 suicidality risk (Columbia-Suicide Severity Rating Scale, C-SSRS), or otherwise judged as inappropriate by the study clinicians
History of a heart transplant, presence of permanent pacemaker implant or Left Ventricular Assist Device
Use of certain medications that can affect heart rate variability, such as beta-blockers, calcium channel blockers, or cardiac glycosides
Use of antidepressant, antipsychotic, anxiolytic, or stimulant medications
Pregnant or planning pregnancy during the study period
Seizure disorder or recent (\<5 years) seizure history
Presence of metal objects in the head/neck
Any skin disorder or skin sensitive area near stimulation locations

Interventions

DEVICEActive Transcranial Direct Current Stimulation (tDCS)

tDCS will be delivered using the 1x1 Mini CT tDCS device. For active tDCS, the device is programmed to ramp up to 2.0 mA (for 30 seconds), provide constant current throughout the session (29 minutes), and then ramp down (for 30 seconds) at the end. Participants will receive 10 sessions of tDCS over the course of this study on weekdays (M-F).

DEVICESham Transcranial Direct Current Stimulation (tDCS)

Sham tDCS will be delivered using the 1x1 Mini CT tDCS device. For sham tDCS, the device is programmed to ramp up to 2.0 mA (for 30 seconds) followed by a ramp down (30 seconds), with no current delivery for 28 minutes, and then ramp up (for 30 seconds) and down (for 30 seconds) at the end. Participants will receive 10 sessions of sham tDCS over the course of this study on weekdays (M-F).