Amphetamine for stroke recovery: a clinical and magnetic resonance imaging study

ISRCTN	ISRCTN12247669
DOI	https://doi.org/10.1186/ISRCTN12247669
Protocol serial number	MCT-38134
Sponsor	Sunnybrook Health Sciences Centre (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca/ (ref: 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

Sunnybrook Health Sciences Centre
Cognitive Neurology, Room A421
2075 Bayview Avenue
Toronto
Ontario
M4N 3M5
Canada

Phone	+1 416 480 4551
Email	sandra.black@sunnybrook.ca

Study information

Primary study design	Interventional
Study design	Multicentre, two-arm, randomised parallel group placebo trial with participant, investigator, caregiver, outcome assessor, and data analyst blinding.
Secondary study design	Randomised controlled trial
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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Amphetamine
Primary outcome measure(s)	Recovery of hemiparesis measured by the Fugl Meyer Motor Assessment at 13 time points up to three months.
Key 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)
Completion date	31/12/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan