NCT01422161

Study of Botulinum Toxin and Recovery of Hand Function After Stroke

Botulinum Toxin Type A Therapy as a Plasticity Inducing Agent for Recovery of Hand Function After Stroke

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke With Hemiparesis

Interventions

Type	Name	Description
DRUG	Botulinum Toxin commonly known as BOTOX®	A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand. There will be 1 treatment cycle during the 9 week study.
DRUG	Placebo	The control group will receive a placebo injection.

Timeline

• Start date: 2010-04-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2011-08-23
• Last updated: 2019-06-20
• Results posted: 2019-05-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study