Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-27 @ 10:52 PM
Study NCT ID:
NCT04897334
Status:
RECRUITING
Last Update Posted:
2024-11-22
First Post:
2021-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke
Sponsor:
University of Pennsylvania
Organization:
Study Overview
Official Title:
Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke (TRAINS): Neuromodulatory Intervention to Ameliorate Cognition After Stroke for Individuals At Risk for VCID.
Status:
RECRUITING
Status Verified Date:
2024-11
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:
TRAINS
Brief Summary:
The purpose of this study is to determine whether a non-invasive brain stimulation technique, transcranial direct current stimulation (tDCS), combined with traditional cognitive therapy will improve cognitive function in patients with subacute stroke.
Detailed Description:
This is a double-blind, sham-controlled study in which subjects with cognitive impairment after stroke will undergo neuropsychological testing before and after receiving 5 semi-consecutive daily sessions of real or sham transcranial direct current stimulation (tDCS) paired with cognitive therapy. Subjects will have experienced a stroke within 3 months of enrollment and will be undergoing inpatient rehabilitation at Penn Institute for Rehabilitation Medicine. Neuropsychological testing will be repeated immediately after completion of stimulation and 3-, 12- and 24- months following completion of treatment. The investigators will examine changes in cognitive performance induced by tDCS + cognitive therapy compared to sham tDCS + cognitive therapy. This study will combine knowledge gained from our behavioral, clinical and sociodemographic data in order to determine the relative degrees to which these properties predict whether persons with post-stroke cognitive impairment will respond to intervention.
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?:
False
Is an FDA AA801 Violation?: