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Study of Botulinum Toxin and Recovery of Hand Function After Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01422161
Recruitment Status : Completed
First Posted : August 23, 2011
Results First Posted : May 31, 2019
Last Update Posted : June 20, 2019
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
NYU Langone Health

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).

Condition or disease Intervention/treatment Phase
Stroke With Hemiparesis Drug: Botulinum Toxin commonly known as BOTOX® Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : April 2010
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
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.

There will be 1 treatment cycle during the 9 week study.

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: Placebo
The control group will receive a placebo injection.




Primary Outcome Measures :
  1. Time Taken to Form a Stable Grasp Pre-Treatment [ Time Frame: Day 1 ]

    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.

  2. Time Taken to Form a Stable Grasp Post Treatment [ Time Frame: 90 Days ]
    • Hand motor impairment (execution and planning) during a functional grasp and lift tasks.
    • Hand function.


Secondary Outcome Measures :
  1. Measure of Upper Limb Motor Impairment Measured by Fugl Meyer Scale [ Time Frame: Pre-Treatment, Day 90 ]

    This scale has 3 points for each item. A zero is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. Reflex activity is measured using 2 points only, with a score of 0 or 3 for absence and presence of reflex. The maximum total score that can be obtained in Fugl Meyer assessment is 226, though it is common practice to assess all domains separately.The five domains assessed by Fugl-Meyer scale are:

    Motor function (Maximum score in upper limb = 66; Maximum score in lower limb = 34) Sensory function (Maximum score = 24) Balance (Maximum score = 14) Range of motion of joints (Maximum score = 44) Joint pain (Maximum score = 44)


  2. Disability Measured by Modified Rankin Scale Score Post-Treatment [ Time Frame: 90 Days ]
    Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.The mRS is an ordered scale coded from 0 (no symptoms at all), 1 (No significant disability despite symptoms; able to carry out all usual duties and activities), 2 (Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance), 3 (Moderate disability; requiring some help, but able to walk without assistance), 4 (Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance), 5 (severe disability) and 6 (death).

  3. Motor Impairment Measured by the Fugl-Meyer Scale Post-Treatment [ Time Frame: 1 Day and 90 Days ]
    Scale is comprised of five domains and there are 155 items in total: Motor functioning (in the upper and lower extremities); Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints); Balance (contains 7 tests, 3 seated and 4 standing); Joint range of motion (8 joints); Joint pain. Each domain contains multiple items, each scored on a 3-point ordinal scale (0 = cannot perform, 1= perform partially, 2 = perform fully).

  4. Disability Measured by Modified Rankin Scale Score Pre-Treatment [ Time Frame: Pre-Treatment ]
    Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.The mRS is an ordered scale coded from 0 (no symptoms at all), 1 (No significant disability despite symptoms; able to carry out all usual duties and activities), 2 (Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance), 3 (Moderate disability; requiring some help, but able to walk without assistance), 4 (Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance), 5 (severe disability) and 6 (death).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01422161


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Allergan
Investigators
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Principal Investigator: Preeti Raghavan, MD NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT01422161     History of Changes
Other Study ID Numbers: 10-01126
10-01126 ( Other Identifier: Institutional Review Board (IRB) - NYU School of Medicine )
First Posted: August 23, 2011    Key Record Dates
Results First Posted: May 31, 2019
Last Update Posted: June 20, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by NYU Langone Health:
Rehabilitation
Fingers
Grasp
Hand
Strength
Brain Infraction
Pathology
Physiopathology
Functional Laterality
Neuronal Plasticity
Psychomotor Performance
Biomechanics
Touch
Weight-Bearing
Additional relevant MeSH terms:
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Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents