Amphetamine for stroke recovery: a clinical and magnetic resonance imaging study
| ISRCTN | ISRCTN12247669 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12247669 |
| Secondary identifying numbers | MCT-38134 |
- Submission date
- 30/03/2007
- Registration date
- 30/03/2007
- Last edited
- 19/11/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sandra Elizabeth Black
Scientific
Scientific
Sunnybrook Health Sciences Centre
Cognitive Neurology, Room A421
2075 Bayview Avenue
Toronto
Ontario
M4N 3M5
Canada
| Phone | +1 416 480 4551 |
|---|---|
| sandra.black@sunnybrook.ca |
Study information
| Study design | Multicentre, two-arm, randomised parallel group placebo trial with participant, investigator, caregiver, outcome assessor, and data analyst blinding. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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. |
| Ethics approval(s) | Approval received from the Research Ethics Board of Sunnybrook & Women's College Health Science Centre (Canada) on the 9th November 1999 (ref: 214-1999). |
| Health condition(s) or problem(s) studied | Stroke |
| Intervention | 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 |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Amphetamine |
| Primary outcome measure | Recovery of hemiparesis measured by the Fugl Meyer Motor Assessment at 13 time points up to three months. |
| Secondary outcome measures | 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) |
| Overall study start date | 01/02/2000 |
| Completion date | 31/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 71 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2000 |
| Date of final enrolment | 31/12/2002 |
Locations
Countries of recruitment
- Canada
Study participating centre
Sunnybrook Health Sciences Centre
Ontario
M4N 3M5
Canada
M4N 3M5
Canada
Sponsor information
Sunnybrook Health Sciences Centre (Canada)
Hospital/treatment centre
Hospital/treatment centre
Research Administration
S123- 2075 Bayview Avenue
Toronto
Ontario
M4N 3M5
Canada
| Phone | +1 416 480 6100 ext 5721 |
|---|---|
| judy.tong@sunnybrook.ca | |
| Website | http://www.sunnybrook.ca/ |
"ROR" |
https://ror.org/03wefcv03 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca/ (ref: MCT-38134)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
