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

Depression Clinical Trial

Official title:

HRV-Guided tDCS: Integrating A Biomarker For Clinical Utility

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06455527
• Other study ID #: 24-00536
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2024
• Est. completion date: November 1, 2027

Study information

• Verified date: June 2024
• Source: NYU Langone Health
• Contact: Luis Fernandez
• Phone: 929-455-5090
• Email: Luis.Fernandez2[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 1, 2027
• Est. primary completion date: November 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Heart Rate (HR) Measured Using Polar H10 Chest Monitor	HR will be measured using Polar H10 Chest Monitor at each daily tDCS session.	Up to Week 4
Primary	Average HR Measured Using i-HR Data Logger	HR will be measured using an impedance-based HR (i-HR) data logger attached to the Mini-CT tDCS device at each daily tDCS session.	Up to Week 4
Secondary	Change in Montgomery ?sberg Depression Rating Scale (MADRS) Score	MADRS is a 10-item assessment of severity of depressive episodes in patients with mood disorders. Each item is rated on a scale from 0-6. The total score is the sum of responses and ranges from 0-60; higher scores indicate greater severity of depressive episodes.	Baseline, End of Intervention (Up to Week 4)
Secondary	Change in State-Trait Anxiety Inventory for Adults (STAI): State Score	STAI is a 40-item questionnaire measuring state and trait anxiety. Each item is rated on a 4-point Likert scale. The range of possible scores for state anxiety ranges from a minimum score of 20 to a maximum score of 80; higher scores indicate greater state anxiety.	Baseline, End of Intervention (Up to Week 4)
Secondary	Change in State-Trait Anxiety Inventory for Adults (STAI): Trait Score	STAI is a 40-item questionnaire measuring state and trait anxiety. Each item is rated on a 4-point Likert scale. The range of possible scores for trait anxiety ranges from a minimum score of 20 to a maximum score of 80; higher scores indicate greater trait anxiety.	Baseline, End of Intervention (Up to Week 4)
Secondary	Change in Positive and Negative Affect Schedule (PANAS-SF): Positive Affect Score	PANAS-SF is a self-report questionnaire that consists of two 10-item scales (20 items total) to measure both positive and negative affect. Each item is rated on a scale from 1 (very slightly or not at all) to 5 (extremely). The total positive affect score is the sum of affect item responses and ranges from 10 - 50; higher scores represent higher levels of positive affect.	Baseline, End of Intervention (Up to Week 4)
Secondary	Change in Positive and Negative Affect Schedule (PANAS-SF): Negative Affect Score	PANAS-SF is a self-report questionnaire that consists of two 10-item scales (20 items total) to measure both positive and negative affect. Each item is rated on a scale from 1 (very slightly or not at all) to 5 (extremely). The total negative affect score is the sum of negative item responses and ranges from 10 - 50; lower scores represent lower levels of negative affect.	Baseline, End of Intervention (Up to Week 4)