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

HRV-Guided tDCS: Integrating A Biomarker For Clinical Utility

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for 100 people with mild to moderate depression. It tests whether heart rate patterns can help show who responds to tDCS, a treatment that uses a weak electrical current to stimulate the brain. People will get real or sham (inactive) treatment at home for 30 minutes a day for 10 days, with remote supervision.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have mild to moderate depression, with a score of 14–28 on the BDI-II depression survey.
  • Meet DSM-V-TR medical guidelines for a period of depression.
  • Score above 85 on the WRAT-4 word-reading test.

Who can't join

  • Have a main brain, nerve, or mental health disorder, or a major medical illness. Examples include stroke, Parkinson’s disease, brain injury, memory problems, past heart attack, diabetes, thyroid disease, or an uneven heartbeat.
  • Have bipolar depression, a disorder that affects contact with reality, or an alcohol or drug use disorder.
  • Have a current or high risk of suicide, or study clinicians decide the study is not suitable for you.
  • Have had a heart transplant, or have a permanent pacemaker or a device that helps the heart pump blood.
  • Take certain drugs that affect heart rate patterns, such as beta-blockers, calcium channel blockers, or cardiac glycosides; or take medicines for depression, psychosis, or anxiety, or stimulant medicines.
  • Are pregnant or plan to become pregnant during the study.
  • Have a seizure disorder or have had a seizure in the past 5 years.
  • Have metal objects in the head or neck, or a skin condition or sensitive skin near where stimulation is given.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NY