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

Last updated: January 6, 2025
Sponsor: NYU Langone Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Treatment

Active Transcranial Direct Current Stimulation (tDCS)

Sham Transcranial Direct Current Stimulation (tDCS)

Clinical Study ID

NCT06455527
24-00536
  • Ages 18-65
  • All Genders

Study 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 Criteria

Inclusion

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

Exclusion Criteria:

  • Primary neurologic, psychiatric (e.g., multiple sclerosis, stroke, Parkinson'sdisease, 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 usedisorder (M.I.N.I.)

  • Active or high suicidality risk (Columbia-Suicide Severity Rating Scale, C-SSRS), orotherwise judged as inappropriate by the study clinicians

  • History of a heart transplant, presence of permanent pacemaker implant or LeftVentricular Assist Device

  • Use of certain medications that can affect heart rate variability, such asbeta-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

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Active Transcranial Direct Current Stimulation (tDCS)
Phase:
Study Start date:
January 02, 2025
Estimated Completion Date:
November 01, 2027

Connect with a study center

  • NYU Langone Health

    New York, New York 10017
    United States

    Active - Recruiting

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