Study of Botulinum Toxin and Recovery of Hand Function After Stroke

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.

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.