A pilot study to estimate the effect-size and possible selection criteria for dexamphetamine treatment during rehabilitation after acute stroke
| ISRCTN | ISRCTN56194158 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56194158 |
| Secondary identifying numbers | N0050119120 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 27/07/2009
- Recruitment status
- Stopped
- Overall study status
- Stopped
- 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 Dagmar Long
Scientific
Scientific
Care of the Elderly
St Luke's Hospital
Little Horton Lane
Bradford
BD5 0NA
United Kingdom
Study information
| Study design | Randomised double blind placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Dexamphetamine has repeatedly been shown to enhance recovery after experimental brain injury in animal models. Our aim is to see whether dexamphetamine, given with rehabilitation treatment early after a stroke, is able to improve the recovery of limb weakness and, if so, to see which groups of patients respond best. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular: Stroke |
| Intervention | This is a placebo-controlled, double-blind, randomised pilot study based within two rehabilitation stroke units. Eligible patients will be randomised to receive either dexamphetamine or placebo, with two-thirds of the subjects receiving dexamphetamine. The medication will be given as a capsule by mouth about 1 h before a 60 min session of rehabilitation. The rehabilitation treatment will be provided in the standard way except that rehabilitation sessions will be timed to occur during the period of peak effect of the study medication. Measurements of recovery will assess residual weakness and disability and will be made by the same health-trained research assistant at 3 and 6 weeks after recruitment and at 3 months after the stroke. Added 27/07/09: trial was stopped due to lack of funding. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | dexamphetamine |
| Primary outcome measure | The extent to which a subject's weakness has recovered at 3 months after the stroke. Interim assessments will occur at 3 and 6 weeks after beginning the trial medication. Assessment of recovery will document residual weakness of the affected arm, trunk and leg (using the Rivermead motor assessment scale) and the subject's degree of independence in basic activities of daily living (using the Barthel Index). In parallel, the subjects mood state will be assessed for depression and lack of motivation. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 16/10/2002 |
| Completion date | 16/10/2004 |
| Reason abandoned (if study stopped) | Lack of funding |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | All patients aged 18 years and over newly admitted to the stroke units in Bradford and Leeds will be assessed by a research assistant for potential recruitment. Eligible subjects will 1. have had a new stroke resulting in a right or left-sided weakness of sufficient severity to require an anticipated minimum 4-week stay on the stroke unit. 2, have a Computed Tomography (CT) scan to exclude intracranial haemorrhage 3. be medically stable and able to participate in daily rehabilitation. |
| Key exclusion criteria | 1. unable to understand language as a result of stroke 2. any memory impairment (pre-existing or as a consequence of the stroke) 3. stable heart disease and untreated high blood pressure 4. any psychiatric treatment within the past 5 years or a past history of drug or alcohol dependence. |
| Date of first enrolment | 16/10/2002 |
| Date of final enrolment | 16/10/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Care of the Elderly
Bradford
BD5 0NA
United Kingdom
BD5 0NA
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
Bradford Hospitals NHS Trust (UK)
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 |
