Study of Botulinum Toxin and Recovery of Hand Function After Stroke
Condition: Stroke With Hemiparesis
MeSH terms: Stroke; Paresis
Intervention: Botulinum Toxin commonly known as BOTOX®; Placebo
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.; The control group will receive a placebo injection.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Rehabilitation; Fingers; Grasp; Hand; Strength; Brain Infraction; Pathology; Physiopathology; Functional Laterality; Neuronal Plasticity; Psychomotor Performance; Biomechanics; Touch; Weight-Bearing

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).
    

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.