Status:
COMPLETED
Improvement of Use Dependent Plasticity in Chronic Stroke Patients
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Healthy
Cerebrovascular Accident
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will examine the role of an amphetamine in improving the effect that electrical nerve stimulation has over brain flexibility associated with motor training in patients who experienced a str...
Detailed Description
OBJECTIVES: There is no universally accepted strategy to promote recovery of motor function after chronic stroke, the main cause of long-term disability among adults. It is desirable to develop strat...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- We will include patients with thromboembolic non-hemorrhagic hemispheric lesions at least 12 months after the stroke.
- We will choose patients who initially had a severe motor paresis (below MRC grade 2), which subsequently recovered to the point that they have a residual motor deficit but can perform the required tasks.
- As a control group, we will include age- and gender matched normal volunteers with matched non-dominant/dominant hand (to the affected hand of the stroke patients).
- EXCLUSION CRITERIA:
- Patients with more than one stroke in the middle cerebral artery territory.
- Patients with bilateral motor impairment.
- Patients with cerebellar or brainstem lesions.
- Patients receiving alpha-adrenergic antagonists or agonists, major/minor tranquilizers, clonidine, prazosin, phonation, benzodiazepines, scopolamine, haloperidol, other neuroleptics, barbiturates and MAO inhibitors.
- Patients or normal volunteers unable to perform the task (wrist or elbow flexion at least MRC grade 2).
- Patients or normal volunteers with history of severe alcohol or drug abuse, psychiatric illness like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 23 or less).
- Patients or normal volunteers with severe uncontrolled medical problems (e.g. hypertension, cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age, uncontrolled epilepsy or others).
- Patients or normal volunteers with increased intracranial pressure as evaluated by clinical means.
- Patients or normal volunteers with unstable cardiac arrhythmia.
- Patients or normal volunteers with history of hyperthyroidism or individuals receiving drugs acting primarily on the central nervous system.
- Patients and normal volunteers with more than moderate to severe microangiopathy, polyneuropathy, diabetes mellitus, or ischemic peripheral disease.
- Pregnancy.
- Patients and normal volunteers less than 18 years of age.
- Lactating women.
Exclusion
Key Trial Info
Start Date :
November 6 2003
Trial Type :
INTERVENTIONAL
End Date :
August 15 2007
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00072735
Start Date
November 6 2003
End Date
August 15 2007
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892