The objective of this study is to examine the effect of a single dose of fluoxetine and of movement observation on cortical activity in chronic stroke patients (>6 months after stroke). As secondary objectives, the effect of fluoxetine on motor function and muscle activity will be measured. MedDRA version: 9.1 Level: LLT Classification code 10055221 Term: Ischemic stroke
Conditions
Interventions
Product Name: fluoxetine
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
Roessingh Research&Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: First ever ischemic stroke, confirmed with a CT-scan or a MRI-scan Unilateral cortical and/or subcortical stroke Stroke more than 6 months ago Some motor dysfunction of the arm/hand but some motor function left (MRC between 2 and 4) Age between 18 and 80 years Obtained informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Other (pre-existing) neurological diseases (e.g. epilepsy, tumor, paralysis) Known allergy to SSRI’s Use of anti-depressants (tricyclic antidepressants, serotonin reuptake inhibitors, MAO-inhibitors) Autism spectrum disorders, PDD, schizophrenia (or history of schizophrenia) Unstable medical health situation (cardiovascular and/or neurological) Uncompensated hemineglect or cognitive disabilities, resulting in misunderstanding or incapability of executing instructions given Uncorrected visual problems, i.e. not able to observe the movie on the screen Pregnancy Severe uncontrolled medical conditions Known alcoholism or drug abuse Known elevated brain pressure (hydrocephalus)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this trial is to examine the influence of a single dose of fluoxetine and of movement observation on cortical activity.;Primary end point(s): Knowledge whether a single dose of fluoxetine is capable of changing brain activity and whether this change has influence on motor function.;Secondary Objective: Secondary objectives are: 1. to examine the effect of fluoxetine on motor function 2. to examine the influence of fluoxetine on muscle activation patterns 3. to examine the correlation between brain activity and muscle activation patterns; 4. to examine the correlation between brain activity and motor outcome; 5. to examine the correlation between muscle activity and motor outcome; | — |
Countries
Netherlands
Outcome results
None listed