Using heart rate variability to guide brain stimulation for depression
HRV-Guided tDCS: Integrating A Biomarker For Clinical Utility
This study is testing if using heart rate data to guide brain stimulation can help people with mild to moderate depression feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06455527 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with mild to moderate depression as indicated by specific diagnostic criteria.
Not a fit: Patients with severe psychiatric disorders, significant medical conditions, or high suicidality risk may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel, non-invasive treatment option for individuals suffering from depression.
How similar studies have performed: While the use of tDCS has been explored in other studies, the specific HRV-guided approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.