Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455527
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-07
Brief Title:
Heart Rate Variability HRV-Guided Transcranial Direct Current Stimulation tDCS
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
HRV-Guided tDCS Integrating A Biomarker For Clinical Utility
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n100 people with mild to moderate depression in a double-blinded parallel-arm sham-controlled data collection period administered at home and using the investigators remotely supervised RS tDCS protocol Enrolled participants will complete 10 days of 30-minute tDCS 20 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 21 to active vs sham tDCS
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None