Actively Recruiting
Heart Rate Variability (HRV)-Guided Transcranial Direct Current Stimulation (tDCS)
Led by NYU Langone Health · Updated on 2025-11-28
100
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
N
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Heart Rate Variability (HRV)-Guided Transcranial Direct Current Stimulation (tDCS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mild to moderate depression with Beck Depression Inventory-II score between 14 and 28
- Diagnosis of depressive episode according to DSM-V-TR
- Wide Range Achievement Test 4th Reading Recognition subtest standard score greater than 85
You will not qualify if you...
- History of neurological or major medical disorders such as multiple sclerosis, stroke, Parkinson's disease, spinal cord injury, brain injury, epilepsy, cognitive impairment, dementia, myocardial infarction, diabetes, thyroid disease, arrhythmia, or atrial fibrillation
- Bipolar depression, psychotic disorder, or alcohol/substance use disorder
- Active or high risk of suicidality or deemed inappropriate by study clinicians
- History of heart transplant, permanent pacemaker, or ventricular assist device
- Use of medications affecting heart rate variability including beta-blockers, calcium channel blockers, or cardiac glycosides
- Current use of antidepressants, antipsychotics, anxiolytics, or stimulants
- Pregnant or planning pregnancy during the study
- Seizure disorder or seizure history within the past 5 years
- Presence of metal objects in the head or neck area
- Skin disorders or sensitive skin near stimulation sites
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10017
Actively Recruiting
Research Team
S
Shayna Pehel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
2
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