Evaluation of the Effect of Dextro-Amphetamin Added to Physiotherapy in Patients After Stroke

• Status: Terminated
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Reha Rheinfelden
• Treatments: Amphetamine

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