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17 May 2012
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| [ ...Back to search results ] | [ Print-friendly version ] |
| Amphetamine for stroke recovery: a clinical and magnetic resonance imaging study |
| ISRCTN | ISRCTN12247669 |
| ClinicalTrials.gov identifier | |
| Public title | Amphetamine for stroke recovery: a clinical and magnetic resonance imaging study |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | MCT-38134 |
| Study hypothesis |
Hypothesis:
Clinical recovery, assessed by validated scales of neurologic impairment and disability at standardised times, will be significantly enhanced in patients recovering from hemiparetic stroke, receiving Amphetamine (AMPH) coupled with rehabilitation versus placebo coupled with rehabilitation. Objective: This project aims to determine whether AMPH paired with rehabilitative training can promote adaptive neuroplasticity and improve clinically-meaningful outcomes in patients recovering from hemiparetic stroke. |
| Lay summary | |
| Ethics approval | Approval received from the Research Ethics Board of Sunnybrook & Women's College Health Science Centre (Canada) on the 9th November 1999 (ref: 214-1999). |
| Study design | Multicentre, two-arm, randomised parallel group placebo trial with participant, investigator, caregiver, outcome assessor, and data analyst blinding. |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Stroke |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/02/2000 |
| Anticipated end date | 31/12/2002 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 71 |
| 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.
Please note that this trial is now completed. Contact for public queries: Dr. David Gladstone Sunnybrook Health Sciences Centre (Canada) A442-2075 Bayview Avenue Toronto, ON M4N 3M5 Canada Tel: +1 416 480 4866 Fax: +1 416 480 5753 Email: david.gladstone@sunnybrook.ca |
| Primary outcome measure(s) | Recovery of hemiparesis measured by the Fugl Meyer Motor Assessment at 13 time points up to three months. |
| Secondary outcome measure(s) |
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) |
| Sources of funding | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca/ (ref: MCT-38134) |
| Trial website | |
| Publications | |
| Contact name | Dr Sandra Elizabeth Black |
| Address |
Sunnybrook Health Sciences Centre
Cognitive Neurology, Room A421 2075 Bayview Avenue Toronto |
| City/town | Ontario |
| Zip/Postcode | M4N 3M5 |
| Country | Canada |
| Tel | +1 416 480 4551 |
| Fax | +1 416 480 4552 |
| sandra.black@sunnybrook.ca | |
| Sponsor | Sunnybrook Health Sciences Centre (Canada) |
| Address |
Research Administration
S123- 2075 Bayview Avenue Toronto |
| City/town | Ontario |
| Zip/Postcode | M4N 3M5 |
| Country | Canada |
| Tel | +1 416 480 6100 ext 5721 |
| Fax | +1 416 480 5814 |
| judy.tong@sunnybrook.ca | |
| Sponsor website: | http://www.sunnybrook.ca/ |
| Date applied | 30/03/2007 |
| Last edited | 19/11/2009 |
| Date ISRCTN assigned | 30/03/2007 |
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