Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06455527

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 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10017, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

Primary outcomes

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

    Time frame: Up to Week 4

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

  2. Average HR Measured Using i-HR Data Logger

    Time frame: Up to Week 4

    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.

Secondary outcomes

  1. Change in Montgomery Ӓsberg Depression Rating Scale (MADRS) Score

    Time frame: Baseline, End of Intervention (Up to Week 4)

    MADRS is a 10-item assessment of severity of depressive episodes in patients with mood disorders. Each item is rated on a scale from 0-6. The total score is the sum of responses and ranges from 0-60; higher scores indicate greater severity of depressive episodes.

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

    Time frame: Baseline, End of Intervention (Up to Week 4)

    STAI is a 40-item questionnaire measuring state and trait anxiety. Each item is rated on a 4-point Likert scale. The range of possible scores for state anxiety ranges from a minimum score of 20 to a maximum score of 80; higher scores indicate greater state anxiety.

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

    Time frame: Baseline, End of Intervention (Up to Week 4)

    STAI is a 40-item questionnaire measuring state and trait anxiety. Each item is rated on a 4-point Likert scale. The range of possible scores for trait anxiety ranges from a minimum score of 20 to a maximum score of 80; higher scores indicate greater trait anxiety.

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

    Time frame: Baseline, End of Intervention (Up to Week 4)

    PANAS-SF is a self-report questionnaire that consists of two 10-item scales (20 items total) to measure both positive and negative affect. Each item is rated on a scale from 1 (very slightly or not at all) to 5 (extremely). The total positive affect score is the sum of affect item responses and ranges from 10 - 50; higher scores represent higher levels of positive affect.

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

    Time frame: Baseline, End of Intervention (Up to Week 4)

    PANAS-SF is a self-report questionnaire that consists of two 10-item scales (20 items total) to measure both positive and negative affect. Each item is rated on a scale from 1 (very slightly or not at all) to 5 (extremely). The total negative affect score is the sum of negative item responses and ranges from 10 - 50; lower scores represent lower levels of negative affect.

Study contacts

Contact information is provided by the study sponsor or research team.

Shayna Pehel

CONTACT

[email protected]

929-455-5104

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Registry information

Official study title

HRV-Guided tDCS: Integrating A Biomarker For Clinical Utility

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 12, 2024
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.