Clinical trial NCT00572767: Evaluation of the Effect of Dextro-Amphetamin Added to Physiotherapy in Patients After Stroke
Official title: Evaluation of the Therapeutic Effect of Amphetamine in Association to Physiotherapy on Motor Recovery After Stroke: a Randomised, Double-Blinded, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Stroke
Keywords: randomised-controlled trial
ischemic stroke
motor recovery
amphetamine
motor recovery of patients after a first-ever ischemic stroke
Lead sponsor: Reha Rheinfelden
Sponsor class: OTHER
First posted: 2007-12-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effect of Dextro-amphetamin added to physiotherapy on motor recovery in patients after stroke. The study is a double-blinded placebo-controlled randomised controlled trial.

Patients after a first-ever ischemic stroke will receive Dexamphetamine (10mg) twice per week for a duration of five weeks after a baseline phase of two weeks.

The outcome measure focuses on motor recovery and will be assessed:

* one and two weeks before study intervention (baseline phase)
* five times during the study intervention
* one week after study intervention (follow-up)
* once after six and twelve months after start of the study intervention (follow-up).


Eligibility criteria: Inclusion Criteria:

* patients after first-ever ischemic stroke with a clinical relevant paresis of the upper and lower limb (general clinical muscle testing below level four)
* correlation of clinical symptoms with a brain imaging (CT or MRI)
* able to communicate with the neurological examiner and understand the aim/matter of the study (with or without aphasia)
* start of the first oral application of the study drug between the fourteenth and 60th day after stroke onset
* older than 13 years
* given written informed consent (or two independent witnesses)

Exclusion Criteria:

* intracranial or (chronic) subdural hemorrhages
* any additional neurological or psychiatric illnesses
* instable arrythmia
* not controlled or treated arterial hypertension
* ensured cardioembolic event
* anxiolytica, neuroleptica, or alpha-adrenergic antagonists or agonists respectively
* certain anticonvulsiva or antihypertonica
* manifest hyperthyreosis
* dementia or terminal illnesses
* epilepsy, phaeochromocytoma or glaucoma
* women known to be pregnant or lactating

Primary outcomes:
measure: Chedoke-McMaster Stroke Assessment (motor impairment measure)
timeFrame: Over the whole duration of the study (2001 to 2006, ten times for each patient)
Secondary outcomes:
Other outcomes:
Locations:
city: Rheinfelden
country: Switzerland
facility: Reha Rheinfelden
state: AG
Study officials:
affiliation: Reha Rheinfelden
name: Thierry M. Ettlin, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schuster C, Maunz G, Lutz K, Kischka U, Sturzenegger R, Ettlin T. Dexamphetamine improves upper extremity outcome during rehabilitation after stroke: a pilot randomized controlled trial. Neurorehabil Neural Repair. 2011 Oct;25(8):749-55. doi: 10.1177/1545968311405674. Epub 2011 Jun 28.