Clinical trial NCT06455527: Heart Rate Variability (HRV)-Guided Transcranial Direct Current Stimulation (tDCS)
Official title: HRV-Guided tDCS: Integrating A Biomarker For Clinical Utility
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Keywords: Depression
Heart Rate
tDCS
Brain stimulation
telehealth
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2024-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Primary outcomes:
measure: Average Heart Rate (HR) Measured Using Polar H10 Chest Monitor
timeFrame: Up to Week 4
measure: Average HR Measured Using i-HR Data Logger
timeFrame: Up to Week 4
Secondary outcomes:
measure: Change in Montgomery Ӓsberg Depression Rating Scale (MADRS) Score
timeFrame: Baseline, End of Intervention (Up to Week 4)
measure: Change in State-Trait Anxiety Inventory for Adults (STAI): State Score
timeFrame: Baseline, End of Intervention (Up to Week 4)
measure: Change in State-Trait Anxiety Inventory for Adults (STAI): Trait Score
timeFrame: Baseline, End of Intervention (Up to Week 4)
measure: Change in Positive and Negative Affect Schedule (PANAS-SF): Positive Affect Score
timeFrame: Baseline, End of Intervention (Up to Week 4)
measure: Change in Positive and Negative Affect Schedule (PANAS-SF): Negative Affect Score
timeFrame: Baseline, End of Intervention (Up to Week 4)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Giuseppina Pilloni, PhD
role: PRINCIPAL_INVESTIGATOR
References: