Using heart rate variability to guide brain stimulation for depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to evaluate the effectiveness of heart rate variability (HRV)-guided transcranial direct current stimulation (tDCS) in individuals with mild to moderate depression. A total of 100 participants will be recruited to undergo a double-blinded, parallel-arm, sham-controlled intervention at home, where they will receive either active or sham tDCS for 30 minutes over 10 days. The study will collect heart rate data during sessions to identify potential markers of response to the treatment. Participants will be randomized in a 2:1 ratio to receive either the active or sham stimulation.

Why it matters

Who can join: the full rules

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

Where it's running

• NYU Langone Health
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Giuseppina Pilloni, PhD — NYU Langone Health
• Study coordinator: Shayna Pehel
• Email: Shayna.Pehel@nyulangone.org
• Phone: 929-455-5104

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.