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

Description

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

HRV-Guided tDCS: Integrating A Biomarker For Clinical Utility

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

Condition
Depression
Intervention / Treatment

-

Contacts and Locations

New York

NYU Langone Health, New York, New York, United States, 10017

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NYU Langone Health,

Giuseppina Pilloni, PhD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

2027-11-01