Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
Study NCT ID:
NCT06286800
Status:
RECRUITING
Last Update Posted:
2025-02-04
First Post:
2024-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Personalized Transcranial Direct Current Stimulation in Stroke Recovery
Sponsor:
The Methodist Hospital Research Institute
Organization:
Study Overview
Official Title:
Personalized Transcranial Direct Current Stimulation in Stroke Recovery
Status:
RECRUITING
Status Verified Date:
2025-01
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:
The central objective of this application is to explore the neural substrate of personalized tDCS (ptDCS) and to determine whether the paradigm for each stroke patient can predict the amount of sustained clinical improvement through increased connectivity as measured by a biomarker of plasticity.
Detailed Description:
This is a randomized, sham controlled double masked parallel group study with optional crossover of chronic (\>3mo from stroke onset) ischemic or hemorrhagic stroke patients to test the effect of ptDCS on a cerebral connectivity biomarker of plasticity during stimulation and after 10 treatment of up to 2 mA ptDCS. PtDCS will be performed during the first 20 minutes of occupational therapy targeting the weaker arm compared to sham. Patients will have the option to cross over after the completion of 1-month follow-up and will complete the same procedures with real tDCS if they were in the sham group.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: