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

NYU Langone Health

Status: Enrolling

Conditions: Depression

Treatments: Device: Sham Transcranial Direct Current Stimulation (tDCS); Device: Active Transcranial Direct Current Stimulation (tDCS)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06455527

24-00536

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Active tDCS

Experimental group

Description:

Participants randomized to the Active tDCS arm will complete 10 sessions of 30-minute active remotely supervised (RS)-tDCS with chest strap and impedance-based HRV data collection over the course of approximately 2-4 weeks.

Treatment:

Device: Active Transcranial Direct Current Stimulation (tDCS)

Sham tDCS

Sham Comparator group

Description:

Participants randomized to the Active tDCS arm will complete 10 sessions of 30-minute sham RS-tDCS with chest strap and impedance-based HRV data collection over the course of approximately 2-4 weeks.

Treatment:

Device: Sham Transcranial Direct Current Stimulation (tDCS)