RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

HRV-Guided tDCS: Integrating A Biomarker For Clinical Utility

Quick Facts

Study Start:2025-01-02
Study Completion:2027-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06455527

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Mild to moderate depression (Beck Depression Inventory(BDI)-II 14-28)
  2. * Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-V-TR) Depressive episode
  3. * Wide Range Achievement Test (WRAT)-4th Reading Recognition subtest standard score \>85
  1. * 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)
  2. * DSM-V-TR bipolar depression, psychotic disorder, or alcohol or substance use disorder (M.I.N.I.)
  3. * Active or high suicidality risk (Columbia-Suicide Severity Rating Scale, C-SSRS), or otherwise judged as inappropriate by the study clinicians
  4. * History of a heart transplant, presence of permanent pacemaker implant or Left Ventricular Assist Device
  5. * Use of certain medications that can affect heart rate variability, such as beta-blockers, calcium channel blockers, or cardiac glycosides
  6. * Use of antidepressant, antipsychotic, anxiolytic, or stimulant medications
  7. * Pregnant or planning pregnancy during the study period
  8. * Seizure disorder or recent (\<5 years) seizure history
  9. * Presence of metal objects in the head/neck
  10. * Any skin disorder or skin sensitive area near stimulation locations

Contacts and Locations

Study Contact

Shayna Pehel
CONTACT
929-455-5104
Shayna.Pehel@nyulangone.org

Principal Investigator

Giuseppina Pilloni, PhD
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

NYU Langone Health
New York, New York, 10017
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Giuseppina Pilloni, PhD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-02
Study Completion Date2027-11-01

Study Record Updates

Study Start Date2025-01-02
Study Completion Date2027-11-01

Terms related to this study

Keywords Provided by Researchers

  • Depression
  • Heart Rate
  • tDCS
  • Brain stimulation
  • telehealth

Additional Relevant MeSH Terms

  • Depression