The effect of fluoxetine on brain excitability and muscle activation will be measured in chronic stroke patients (> 6 months after stroke). As secondary measures, also brain activation, phase-synchronization in the brain, and motor function will be studied. MedDRA version: 8.1 Level: LLT Classification code 10055221 Term: Ischemic stroke
Conditions
Interventions
Product Name: fluoxetine
Pharmaceutical Form: Capsule*
INN or Proposed INN: fluoxetinum
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of t
Sponsors
Roessingh Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: First ever ischemic cortical/subcortical ischemic stroke, confirmed by CT or MRI; more than 6 months after stroke; age > 18 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: Patients suffering from another neurological disease; uncompensated hemineglect or cognitive disabilities; epilepsy, or first epileptic insult post stroke; patients with first grade relatives suffering from epilepsy; pregnancy; pacemaker; pathological heart rhythms disorders; use of antidepressants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objectives of the study are to investigate if fluoxetine influences brain excitability and muscle activation in such a way it could improve motor function. This objective will be measured by answering following hypotheses: Hypothesis 1: Long-term use of fluoxetine causes the excitability of the primary motor area of the brain to change. Hypothesis 2: Long-term administration of fluoxetine causes the muscle activation patterns to increase. ;Secondary Objective: Secondary objective of the study is to examine if fluoxetine causes the activation and communication of brain areas to change. In addition, the motor function will be measured to examine if the potential changes are large enough to cause the motor function to change. These objectives are tested by the following hypotheses: Hypothesis 3: Long-term use of fluoxetine modulates activation of areas of the brain during voluntary movement. Hypothesis 4: Long-term use of fluoxetine increases the communication between areas of the brain. Hypothesis 5: Long-term administration of fluoxetine causes the motor function to change. Also the correlation between all outcome measures will be analyzed, to understand the linking between the different parameters. ;Primary end point(s): Knowledge if long-term administration of fluoxetine changes brain excitability and muscle activation in chronic stroke patients, and if it is possible that fluoxetine promotes motor function in stroke patients. | — |
Countries
Netherlands
Outcome results
None listed