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

ConditionDepression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNYU Langone Health

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Active Transcranial Direct Current Stimulation (tDCS)

    Device

    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)

    Device

    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).

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Active tDCSExperimental treatment 1 intervention
Group B: Sham tDCSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Average Heart Rate (HR) Measured Using Polar H10 Chest Monitor

HR will be measured using Polar H10 Chest Monitor at each daily tDCS session.

Time frame
Up to Week 4
2

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.

Time frame
Up to Week 4

Secondary outcomes

1

Change in Montgomery Ӓsberg 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.

Time frame
Baseline, End of Intervention (Up to Week 4)
2

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.

Time frame
Baseline, End of Intervention (Up to Week 4)
3

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.

Time frame
Baseline, End of Intervention (Up to Week 4)
4

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.

Time frame
Baseline, End of Intervention (Up to Week 4)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Source ClinicalTrials.gov
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