Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-29 @ 8:43 AM
Study NCT ID:
NCT01963832
Status:
WITHDRAWN
Last Update Posted:
2015-01-12
First Post:
2013-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RCT of a Neuroplasticity Agent and CI Therapy for Severe Arm Paresis After Stroke
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
Official Title:
RCT of a Neuroplasticity Agent and CI Therapy for Severe Arm Paresis After Stroke
Status:
WITHDRAWN
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
not funded
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Stroke patients who have little or no voluntary movement in the hand on the more affected side of their body more than one year after stroke have few treatment options. This project proposes to test the efficacy of a form of Constraint-Induced Movement therapy designed for patients with such severe impairment in conjunction with an agent, fluoxetine, which has been shown in some studies to enhance brain neuroplasticity in response to training. Constraint-Induced Movement therapy, which is abbreviated CIMT, is a form of physical rehabilitation based on basic research in neuroscience and behavioral science. If the project is successful, an efficacious, evidence-based therapy will become available to stroke patients for what is now a largely untreated condition
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: