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

Official title

HRV-Guided tDCS: Integrating A Biomarker For Clinical Utility

Overview

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.

Interventions

• Device Active Transcranial Direct Current Stimulation (tDCS)
  tDCS will be delivered using the 1x1 Mini CT tDCS device. For active tDCS, the device is programmed to ramp up to 2.0 mA (for 30 seconds), provide constant current throughout the session (29 minutes), and then ramp down (for 30 seconds) at the end. Participants will receive 10 sessions of tDCS over the course of this study on weekdays (M-F).
• Device Sham Transcranial Direct Current Stimulation (tDCS)
  Sham tDCS will be delivered using the 1x1 Mini CT tDCS device. For sham tDCS, the device is programmed to ramp up to 2.0 mA (for 30 seconds) followed by a ramp down (30 seconds), with no current delivery for 28 minutes, and then ramp up (for 30 seconds) and down (for 30 seconds) at the end. Participants will receive 10 sessions of sham tDCS over the course of this study on weekdays (M-F).

Primary outcome measures

• Average Heart Rate (HR) Measured Using Polar H10 Chest Monitor [Time frame: Up to Week 4]
• Average HR Measured Using i-HR Data Logger [Time frame: Up to Week 4]

Secondary outcome measures (5)

• Change in Montgomery Ӓsberg Depression Rating Scale (MADRS) Score [Time frame: Baseline, End of Intervention (Up to Week 4)]
• Change in State-Trait Anxiety Inventory for Adults (STAI): State Score [Time frame: Baseline, End of Intervention (Up to Week 4)]
• Change in State-Trait Anxiety Inventory for Adults (STAI): Trait Score [Time frame: Baseline, End of Intervention (Up to Week 4)]
• Change in Positive and Negative Affect Schedule (PANAS-SF): Positive Affect Score [Time frame: Baseline, End of Intervention (Up to Week 4)]
• Change in Positive and Negative Affect Schedule (PANAS-SF): Negative Affect Score [Time frame: Baseline, End of Intervention (Up to Week 4)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Single group

Masking

Double blind

Primary purpose

Other

Study locations

United States · 1 center

• NYU Langone Health — New York

Identifiers

NCT: NCT06455527 · 24-00536

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗