Heart Rate Variability (HRV)-Guided Transcranial Direct Current Stimulation (tDCS)
HRV-Guided tDCS: Integrating A Biomarker For Clinical Utility
- Depression
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- NYU Langone Health
- Enrolment target
- 100
- Started
- 2 January 2025
- Main results due
- 1 November 2027
- Study sites
- 1
- Registry updated
- 25 September 2026
Can you take part?
- Ages 18 years to 65 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
NYU Langone Health
New York, New York, United States
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06455527. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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