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Study of Botulinum Toxin and Recovery of Hand Function After Stroke

Primary Purpose

Stroke With Hemiparesis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Botulinum Toxin commonly known as BOTOX®
Placebo
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke With Hemiparesis focused on measuring Rehabilitation, Fingers, Grasp, Hand, Strength, Brain Infraction, Pathology, Physiopathology, Functional Laterality, Neuronal Plasticity, Psychomotor Performance, Biomechanics, Touch, Weight-Bearing

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Botulinum Toxin commonly known as BOTOX®

Placebo

Arm Description

Some subjects will receive BOTOX® injections. Subject will not be informed of what injection they received.

Some subject will receive a safe Placebo injection. Subjects will not be informed of what injection they have received.

Outcomes

Primary Outcome Measures

Time Taken to Form a Stable Grasp Pre-Treatment
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.
Time Taken to Form a Stable Grasp Post Treatment
Hand motor impairment (execution and planning) during a functional grasp and lift tasks. Hand function.

Secondary Outcome Measures

Measure of Upper Limb Motor Impairment Measured by Fugl Meyer Scale
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)
Disability Measured by Modified Rankin Scale Score Post-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).
Motor Impairment Measured by the Fugl-Meyer Scale Post-Treatment
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).
Disability Measured by Modified Rankin Scale Score 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).

Full Information

First Posted
August 19, 2011
Last Updated
June 4, 2019
Sponsor
NYU Langone Health
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01422161
Brief Title
Study of Botulinum Toxin and Recovery of Hand Function After Stroke
Official Title
Botulinum Toxin Type A Therapy as a Plasticity Inducing Agent for Recovery of Hand Function After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Allergan

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke With Hemiparesis
Keywords
Rehabilitation, Fingers, Grasp, Hand, Strength, Brain Infraction, Pathology, Physiopathology, Functional Laterality, Neuronal Plasticity, Psychomotor Performance, Biomechanics, Touch, Weight-Bearing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botulinum Toxin commonly known as BOTOX®
Arm Type
Experimental
Arm Description
Some subjects will receive BOTOX® injections. Subject will not be informed of what injection they received.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Some subject will receive a safe Placebo injection. Subjects will not be informed of what injection they have received.
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin commonly known as BOTOX®
Other Intervention Name(s)
BOTOX®, Saline
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The control group will receive a placebo injection.
Primary Outcome Measure Information:
Title
Time Taken to Form a Stable Grasp Pre-Treatment
Description
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.
Time Frame
Day 1
Title
Time Taken to Form a Stable Grasp Post Treatment
Description
Hand motor impairment (execution and planning) during a functional grasp and lift tasks. Hand function.
Time Frame
90 Days
Secondary Outcome Measure Information:
Title
Measure of Upper Limb Motor Impairment Measured by Fugl Meyer Scale
Description
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)
Time Frame
Pre-Treatment, Day 90
Title
Disability Measured by Modified Rankin Scale Score Post-Treatment
Description
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).
Time Frame
90 Days
Title
Motor Impairment Measured by the Fugl-Meyer Scale Post-Treatment
Description
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).
Time Frame
1 Day and 90 Days
Title
Disability Measured by Modified Rankin Scale Score Pre-Treatment
Description
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).
Time Frame
Pre-Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Preeti Raghavan, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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Study of Botulinum Toxin and Recovery of Hand Function After Stroke

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