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

Plain Language Summary

Simplified for easier understanding

This study tests whether brain stimulation guided by heart rate patterns can improve depression. The technique — called tDCS (transcranial direct current stimulation) — delivers a very mild electrical current to the scalp to gently stimulate brain activity. **You may be eligible if...** - You have been diagnosed with a depressive episode (based on DSM-5 criteria) - Your depression symptoms are in the mild-to-moderate range on a standard scale (BDI-II score of 14–28) - You have adequate reading ability (standard score above 85) **You may NOT be eligible if...** - You have a primary neurological or psychiatric disorder such as MS, stroke, Parkinson's disease, traumatic brain injury, epilepsy, or significant cognitive impairment - You have a spinal cord injury - You have an intracranial mass (such as a brain tumor) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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).