Stroke Circulatory System Cerebrovascular diseases
Conditions
Interventions
10 mg amphetamine followed 90 minutes later by one hour physiotherapies, starting five to ten days post stroke, every three to four days for ten drug therapy sessions, versus a matched placebo.
Pleas
Sponsors
Sunnybrook Health Sciences Centre (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female or male, 30 to 65 year old 2. Ischaemic hemispheric stroke patients with moderate to severe hemiparesis 3. Medically able to participate in a rehabilitation program and expected to survive three months post-stroke 4. Pre-morbid modified Rankin score zero or one 5. Informed consent from patient or substitute decision maker
Exclusion criteria
Exclusion criteria: 1. Brainstem or cerebellar stroke 2. Primary intracerebral haemorrhage 3. Pre-existing neurologic deficit (e.g. from prior stroke) that could interfere with assessments 4. Pregnancy and lactation 5. Prior history of dementia 6. Known hypersensitivity to sympathomimetic amines 7. Unstable cardiac arrhythmia or hypertension not controlled by medication (greater than 170/105 mmHg) 18. History of psychosis or tic disorder 19. Untreated hyperthyroidism 20. Concomitant use of alpha-adrenergic antagonists or agonists 21. Concomitant use of monoamine oxidase inhibitors or use within the preceding 14 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recovery of hemiparesis measured by the Fugl Meyer Motor Assessment at 13 time points up to three months. | — |
Secondary
| Measure | Time frame |
|---|---|
| All secondary outcomes are measured at baseline, six weeks, and at three months: 1. National Institute of Health Stroke Scale (NIHSS) 2. Western Aphasia Battery (WAB) 3. Sunnybrook Neglect Assessment Procedure (SNAP) 4. Montgomery/Ashberg Depression Rating Scale 5. Apathy Scale 6. Structured Clinical Interview for Diagnostic and Statistical Manual of mental disorders fourth edition (SCID-DSM-IV) 7. Ideomotor Praxis 8. Chedoke-McMaster Stroke Assessment 9. Clinical Outcomes Variable Scale (COVS) 10. Stroke Rehabilitation Assessment of Movement (STREAM) 11. Barthel Index Scale 12. Functional Independence Measure (FIM) 13. Modified Rankin Scale (MRS) 14. Stroke Impact Scale (SIS) 15. Chedoke Arm and Hand Activity Inventory 16. Mini Mental State Examination (MMSE) | — |
Countries
Canada
Outcome results
None listed