Study of Botulinum Toxin and Recovery of Hand Function After Stroke - Full Text View

Purpose

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).

Condition	Intervention	Phase
Stroke With Hemiparesis	Drug: Botulinum Toxin commonly known as BOTOX®	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	Botulinum Toxin Type A Therapy as a Plasticity Inducing Agent for Recovery of Hand Function After Stroke

Resource links provided by NLM:

MedlinePlus related topics: Botox

Drug Information available for: OnabotulinumtoxinA

U.S. FDA Resources

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:

Measurement of Hand function. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Assessments are done on day 1, before the 1st Botulinum toxin injection.

They will be assessed for:
- Hand motor impairment (execution and planning) during a functional grasp and lift tasks.
- Hand function.

Secondary Outcome Measures:

Measurement of Hand function [ Time Frame: Day 90 (midpoint of study) ] [ Designated as safety issue: No ]
Subjects will be assessed at the midpoint of the (Day 90) after the first Botox injection. They will be assessed for:
- change in hand motor impairment (execution and planning) during a functional grasp and lift tasks.
- Hand function.

Estimated Enrollment:	32
Study Start Date:	April 2010
Estimated Study Completion Date:	July 2014
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Botulinum Toxin commonly known as BOTOX® Some subjects will receive BOTOX® injections. Subject will not be informed of what injection they received.	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. The control group will receive a placebo injection. There will be 2 treatment cycles 12 weeks apart. Other Names: BOTOX® Saline
Placebo Comparator: Placebo Some subject will receive a safe Placebo injection. Subjects will not be informed of what injection they have received.	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. The control group will receive a placebo injection. There will be 2 treatment cycles 12 weeks apart. Other Names: BOTOX® Saline

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ability to follow study instructions and likely to complete all required visits
Ability to comply with the therapy protocol as assessed by the investigator
3 months post first-time unilateral stroke with right or left hemiparesis and complaints of unilateral hand dysfunction
Must have ability to grasp and lift the test object
Subjects must have upper extremity motor impairment

Exclusion Criteria:

Known allergy or sensitivity to botulinum toxin type A (BOTOX).
Females with a positive pregnancy test, or who are breast-feeding, planning a pregnancy during the study, who think that they may be pregnant at the start of the study or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
Concurrent participation in another investigational drug or device study or participation in another Botulinum toxin study in the 6 months prior to study.
Treatment with botulinum toxin of any serotype in the 3 months prior to study enrollment
Any medical condition that may put the subject at increased risk with exposure to BOTOX including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amytrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function.
Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition.
Infection or skin disorder at an anticipated injection site.
Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
History of surgery or other significant injury to either upper extremity causing mechanical limitations that preclude task performance.
Previous neurological illness such as head trauma, prior stroke, epilepsy, or demyelinating disease.
Complicating medical problems such as uncontrolled hypertension, diabetes with signs of polyneuropathy, severe renal, cardiac or pulmonary disease, or evidence of other concurrent neurologic or orthopedic conditions precluding the subject from complying with the study protocol.
Current treatment with intrathecal baclofen.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01422161

Contacts

Contact: Preeti Raghavan, MD	212-263-0344	preeti.raghavan@nyumc.org
Contact: Zena Moore	212-263-0344	zena.moore@nyumc.org

Locations

United States, New York
New York University School of Medicine	Recruiting
New York, New York, United States, 10016
Contact: Preeti Raghavan, MD 212-263-0344
Principal Investigator: Preeti Raghavan, MD

Sponsors and Collaborators

New York University School of Medicine

Allergan

Investigators

Principal Investigator:

Preeti Raghavan, MD

New York University School of Medicine

More Information

No publications provided

Responsible Party:	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT01422161 History of Changes
Other Study ID Numbers:	10-01126, 10-01126
Study First Received:	August 19, 2011
Last Updated:	December 20, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by New York University School of Medicine:

Rehabilitation
Fingers
Grasp
Hand
Strength
Brain Infraction
Pathology

Physiopathology
Functional Laterality
Neuronal Plasticity
Psychomotor Performance
Biomechanics
Touch
Weight-Bearing

Additional relevant MeSH terms:

Paresis
Stroke
Cerebral Infarction
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

Brain Infarction
Brain Ischemia
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013