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

Reha Rheinfelden

Status and phase: Terminated; Phase 4

Conditions: Stroke

Treatments: Other: Glucose; Drug: Dextro-Amphetamin

Study type: Interventional

Funder types: Other

Identifiers

NCT00572767

2000/001

2000/030

Details and patient eligibility

About

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).

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Dextro-Amphetamin

2

Placebo Comparator group

Treatment:

Other: Glucose