The objective of this study is to examine the influence of a single dose of fluoxetine and of movement observation on cortical activity, and to relate the changes of the activity of the brain to muscle activation, motor function and motor control in…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the change in cortical activity after
administration of fluoxetine and during movement observation. Secondary
parameters are muscle activation patterns and motor outcomes (Fugl-Meyer and
force). The changes of brain activity will be correlated with the changes in
muscle activity and motor outcome. The changes of muscle activity will also be
correlated with those in motor outcome.
Secondary outcome
Secondary parameters are muscle activation patterns and motor outcomes
(Fugl-Meyer and force). The changes of brain activity will be correlated with
the changes in muscle activity and motor outcome. The changes of muscle
activity will also be correlated with those in motor outcome.
Background summary
The goal of this study is to understand the effect of fluoxetine on
rehabilitation after stroke and the role of movement observation in this
process. Changes of cortical activity during observation and during execution
of a movement and muscle activation patterns during wrist movements after
intake of fluoxetine and placebo will be measured and compared, and will also
be correlated to motor outcome.
Study objective
The objective of this study is to examine the influence of a single dose of
fluoxetine and of movement observation on cortical activity, and to relate the
changes of the activity of the brain to muscle activation, motor function and
motor control in chronic stroke patients.
Study design
The study is a double-blind, randomized, placebo-controlled, cross-over design.
Intervention
The intervention consists of the administration of a single dose of 20 mg
fluoxetine on one day and the administration of placebo on the other day to all
participants.
Study burden and risks
The patients need to come to Roessingh R&D on two days which are 14 days apart.
The non-invasive measurements will take 1 hour in the morning and 1.75 hours in
the afternoon. Patients have to stay at the RRD, or Het Roessingh between the
measurements on one day. Therefore, the total time for the patient is 7.5 hours
on each of the 2 days.
All measurements consist of the Fugl-Meyer motor assessment, EMG of two muscles
of the lower arm and a recording of force of these muscles. The afternoon
measurements also include a 64-channel EEG measurement. The EEG will be
measured during eyes open, eyes closed, movement observation and movement
execution. These measurements will be performed twice a day, five hours apart.
In between, the patient will receive a capsule with a single dose of 20 mg
fluoxetine on one day and a placebo capsule on the other measurement day. The
risk of participation in this study is low. Personal benefit of participation
is not to be expected.
Roessinghbleekweg 33B
7500 AH Enschede
NL
Roessinghbleekweg 33B
7500 AH Enschede
NL
Listed location countries
Age
Inclusion criteria
minimal six months post-stroke
first-ever stroke
unilateral and/or subcortical stroke
age between 18 and 80 years
some motor dysfunction of the arm/hand but some remaining motor function (MRC between 2 and 4)
obtained informed consent
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)
instable 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-003349-97-NL |
| CCMO | NL23063.044.08 |