Recruiting

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

Sponsor:

NYU Langone Health

Code:

NCT06455527

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Active Transcranial Direct Current Stimulation (tDCS)

Sham Transcranial Direct Current Stimulation (tDCS)

Study Details

Brief 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.

Conditions

Depression

Study ID

NCT06455527

Start date

Jan 2, 2025

Status verified date

Nov, 2025

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Active tDCS

Participants randomized to the Active tDCS arm will complete 10 sessions of 30-minute active remotely supervised (RS)-tDCS with chest strap and impedance-based HRV data collection over the course of approximately 2-4 weeks.

sham comparator: Sham tDCS

Participants randomized to the Active tDCS arm will complete 10 sessions of 30-minute sham RS-tDCS with chest strap and impedance-based HRV data collection over the course of approximately 2-4 weeks.

Interventions

Active 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).

Sham 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).

Primary outcome measure

Average Heart Rate (HR) Measured Using Polar H10 Chest Monitor [ Time Frame: Up to Week 4 ]
Average HR Measured Using i-HR Data Logger [ Time Frame: Up to Week 4 ]

Central Contacts and Locations

Central contacts

Shayna Pehel

929-455-5104 Shayna.Pehel@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10017

More Information

Sponsor

NYU Langone Health

Last update posted

Nov 28, 2025

Last verified

Nov, 2025

Keywords

Depression
Heart Rate
tDCS
Brain stimulation
telehealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2025-11-28.