Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT05816603
Status:
RECRUITING
Last Update Posted:
2025-03-20
First Post:
2023-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transcranial Direct Current Stimulation for Post-stroke Fatigue
Sponsor:
Weill Medical College of Cornell University
Organization:
Study Overview
Official Title:
Home-based Post-stroke Fatigue Treatment Using Transcranial Direct Current Stimulation (tDCS)
Status:
RECRUITING
Status Verified Date:
2025-03
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 investigators hypothesize that delivery of anodal tDCS to the left frontal head region will reduce fatigue severity following stroke.
Detailed Description:
The purpose of this study is to investigate transcranial direct current stimulation (tDCS) as a home-based non-pharmacologic intervention for post-stroke fatigue (PSF). Investigators will perform a double-blind, sham-controlled, randomized clinical trial with 24 subjects; 12 will receive sham stimulation and 12 will receive real stimulation. After a baseline assessment, the tDCS device will be applied for 20 minutes, once daily over the left dorsolateral prefrontal cortex (DLPFC), for a total of two weeks. Follow-up assessments with outcome metrics will be completed after the seventh and fourteenth sessions, and one-month following the start date (2 weeks post-treatment). Neuroimaging will be completed at baseline and post-treatment.
Study Oversight
Has Oversight DMC:
True
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?: