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

This study is looking at how a treatment called Transcranial Direct Current Stimulation (tDCS) affects people with mild to moderate depression. tDCS uses a device to deliver a gentle electrical current to the brain. Researchers want to see if changes in your heart rate (Heart Rate Variability or HRV) can show how well tDCS is working. You would receive either active tDCS or a sham (inactive) tDCS. The study aims to enroll 100 people aged 18 to 65 who have mild to moderate depression and meet specific reading ability criteria. The main goal is to measure your average heart rate using special monitors during the treatment period.

Study design
This is a double-blind, parallel-arm, sham-controlled study, meaning neither you nor the researchers will know if you are receiving active tDCS or sham tDCS. About 100 participants with mild to moderate depression will be enrolled.
What's involved
You would complete 10 days of 30-minute tDCS sessions at home, supervised remotely. During each daily session, heart rate data will be collected using a chest monitor and the tDCS headset.
Compensation
Not stated in the trial record.
Follow-up
Your average heart rate will be measured for up to 4 weeks after starting the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06455527

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

Recruiting
NAAges 18–65Interventional
NYU Langone Health
~100 participants
Updated 2025-11-28 on ClinicalTrials.gov
What's tested:Active Transcranial Direct Current Stimulation (tDCS)Sham Transcranial Direct Current Stimulation (tDCS)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Average Heart Rate (HR) Measured Using Polar H10 Chest Monitor
Measured over Up to Week 4
+1 more outcome measured

Conditions

Depression

Explore related trials

Depression

NCT06455527

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • NYU Langone Health

    New York, New Yorkno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Giuseppina Pilloni, PhD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Shayna Pehel
[email protected]
929-455-5104
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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 trial measures

  • Average Heart Rate (HR) Measured Using Polar H10 Chest MonitorUp to Week 4

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

  • Average HR Measured Using i-HR Data LoggerUp 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.