Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2025-12-27 @ 9:59 PM
Study NCT ID:
NCT01422161
Status:
COMPLETED
Last Update Posted:
2019-06-20
First Post:
2011-08-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Botulinum Toxin and Recovery of Hand Function After Stroke
Sponsor:
NYU Langone Health
Organization:
Study Overview
Official Title:
Botulinum Toxin Type A Therapy as a Plasticity Inducing Agent for Recovery of Hand Function After Stroke
Status:
COMPLETED
Status Verified Date:
2019-06
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 purpose of this study is to determine whether injections of botulinum toxin (commonly known as BOTOX®) into the affected hand of Stroke patients, while targeting the muscles controlling the hand, will lead to improved use of the hand when compared to injections of placebo (a substance that looks similar to the study drug but contains no active study medication).
Detailed Description:
Hemiparesis is the most common motor impairment after stroke that frequently leads to persistent deficits in hand function. This study investigates whether the application of botulinum toxin to a set of synergistically-acting hand muscles, in conjunction with task-specific therapy, will lead to reorganization and improved motor function in the stroke-involved hand. The investigators will use objective psychophysical measures of hand function and hand function rating scales to investigate if Botox in conjunction with task-specific therapy will lead to:
* improved motor execution,
* improved motor planning during a psychophysical two-finger grasping and lifting task with varying object weight, and
* increased hand function as assessed by the time taken to complete fine motor tasks.
* improved motor execution,
* improved motor planning during a psychophysical two-finger grasping and lifting task with varying object weight, and
* increased hand function as assessed by the time taken to complete fine motor tasks.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 10-01126 | OTHER | Institutional Review Board (IRB) - NYU School of Medicine | View |