NCT06455527 Heart Rate Variability (HRV)-Guided Transcranial Direct Current Stimulation (tDCS)
| NCT ID | NCT06455527 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-01-02 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-01-02 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Giuseppina Pilloni, PhD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT06455527 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06455527 currently recruiting?
Yes, NCT06455527 is actively recruiting participants. Contact the research team at Shayna.Pehel@nyulangone.org for enrollment information.
Where is the NCT06455527 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06455527 clinical trial?
NCT06455527 is sponsored by NYU Langone Health. The principal investigator is Giuseppina Pilloni, PhD at NYU Langone Health. The trial plans to enroll 100 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.