Influence of long-term administration of fluoxetine on cerebral threshold and muscle activity patterns in chronic stroke patients.

Stroke is one of the major causes of disability in developed countries. After
stroke most patients suffer from hemiparesis, and mainly the distal parts of
the body are affected. Even after intensive training many patients still suffer
from motor impairment. One
Previous studies have been done examining the effects of neuropharmaca on motor
recovery.
One neuropharmaca of which the effect is studied before are selective serotonin
reuptake inhibitors (SSRIs). However, inconsistent results were found, as some
studies found an improved motor function, while other studies did not found any
effects. These studies only measured motor function.
While several fundamental variables are correlated with a changed motor
function, this study examines the effects of fluoxetine (SSRI) on these
variables and relates these changes to motor function. This will possibly
explain why fluoxetine could improve motor function. Hypotheses are: (1)
Long-term use of fluoxetine causes the excitability of the primary motor area
of the brain to change; (2) Long-term administration of fluoxetine causes the
muscle activation patterns to increase; (3)Long-term use of fluoxetine
modulates activation of areas in the brain during voluntary movement; (4)
Long-term administration of lfuoxetine increase the communication between areas
of the brain; (5) Long-term administration of fluoxetine causes the motor
function to change.

Objective of the study is to measure the effects of long term fluoxetine
administration on brain- and muscle activity in combination with the effects on
motor function.
Main questions are:
(1) Influences long-term administration of fluoxetine excitability of the
primary motor cortex of the brain?
(2) Does long-term administration of fluoxetine increase the muscle activation
patterns?

Secondary questions are:
(3) Influences long term administration of fluoxetine activity patterns in the
brain?
(4) Does communication between areas in the brain improve after long term
administration of fluoxetine?
(5) Does motor function improve after long term administration of fluoxetine?

Doubleblind placebo controlled study

17 Patients have to administer one tablet containing 20 mg of fluoxetine every
day during 12 weeks. The other 17 patients receive one tablet of placebo every
day.

Therapeutic risks of the current study, are the side effects of fluoxetine.
These side effects are mostly nausea and restlessness. However some harsh side
effects, like serotoninesyndrom, occur rarely. All reported side effects are
mentioned in the IB.

Non-therapeutic risk comes from the use of transcranial magnetic stimulation
(TMS) which is used to measure brain excitability. A rarely occuring side
effect is the activation of an epileptic insult.