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

NCT06455527 | Recruiting DMC FDA Device

• 1 other identifier: 24-00536
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Depression; Heart Rate; tDCS; Brain stimulation; telehealth

Outcome Measures

Primary Outcomes (2)

• Average Heart Rate (HR) Measured Using Polar H10 Chest Monitor

  HR will be measured using Polar H10 Chest Monitor at each daily tDCS session.

  Up to Week 4

• Average HR Measured Using i-HR Data Logger

  HR will be measured using an impedance-based HR (i-HR) data logger attached to the Mini-CT tDCS device at each daily tDCS session.

  Up to Week 4

Secondary Outcomes (5)

• Change in Montgomery Ӓsberg Depression Rating Scale (MADRS) Score

  Baseline, End of Intervention (Up to Week 4)

• Change in State-Trait Anxiety Inventory for Adults (STAI): State Score

  Baseline, End of Intervention (Up to Week 4)

• Change in State-Trait Anxiety Inventory for Adults (STAI): Trait Score

  Baseline, End of Intervention (Up to Week 4)

• Change in Positive and Negative Affect Schedule (PANAS-SF): Positive Affect Score

  Baseline, End of Intervention (Up to Week 4)

• Change in Positive and Negative Affect Schedule (PANAS-SF): Negative Affect Score

  Baseline, End of Intervention (Up to Week 4)

Study Arms (2)

Active tDCS

EXPERIMENTAL

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.

Device: Active Transcranial Direct Current Stimulation (tDCS)

Sham tDCS

SHAM COMPARATOR

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.

Device: Sham Transcranial Direct Current Stimulation (tDCS)

Interventions

Active Transcranial Direct Current Stimulation (tDCS) DEVICE

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).

Active tDCS

Sham Transcranial Direct Current Stimulation (tDCS) DEVICE

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).

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10017, United States

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Giuseppina Pilloni, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shayna Pehel

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 12, 2024
• Study Start: January 2, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposes to use the data will be granted access upon reasonable request. Requests should be directed to Giuseppina.Pilloni@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)