No registrations found.
ID
Source
Brief title
Health condition
stroke
Sponsors and support
Intervention
Outcome measures
Primary outcome
- EEG after fluoxetine intake and during movement observation
Secondary outcome
- Fugl-Meyer motor assessment, EMG, force production
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.
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.
The study is a double-blind, randomized, placebo-controlled, cross-over design.
Twenty chronic stroke patients (>6 months post-stroke), between 18 and 80 years old with an MRC between 2 and 4 will be recruited for this study.
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.
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.
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.
Study objective
Fluoxetine and movement observation are able to increase cortical activity after stroke
Study design
Measurements are two weeks apart
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.
Rehabilitation Centre
P.O. Box 310
H.I. Genderen, van
Roessingbleekweg 33B
Enschede 7500 AH
The Netherlands
+31 (0)53 4875765
h.vangenderen@rrd.nl
Rehabilitation Centre
P.O. Box 310
H.I. Genderen, van
Roessingbleekweg 33B
Enschede 7500 AH
The Netherlands
+31 (0)53 4875765
h.vangenderen@rrd.nl
Inclusion criteria
1. First ever ischemic stroke, confirmed with a CT-scan or MRI-scan
2. Unilateral cortical and/or subcortical stroke
3. Stroke more than 6 months ago
4. Some motor dysfunction of the arm/hand but some motor function left (MRC between 2 and 4)
5. Age between 18 and 80 years
6. Obtained informed consent
Exclusion criteria
1. Other (pre-existing) neurological diseases (e.g. epilepsy, tumor, paralysis)
2. Known allergy to SSRI’s
3. Use of anti-depressants (tricyclic antidepressants, serotonin reuptake inhibitors, MAO-inhibitors)
4. Autism spectrum disorders, PDD, schizophrenia (or history of schizophrenia)
5. Unstable medical health situation (cardiovascular and/or neurological)
6. Uncompensated hemineglect or cognitive disabilities, resulting in misunderstanding or incapability of executing instructions given
7. Uncorrected visual problems, i.e. not able to observe the movie on the screen
8. Pregnancy
9. Breastfeeding
10. Known kidney dysfunctions
11. Severe uncontrolled medical conditions
12. Known alcoholism or drug abuse
13. Known elevated brain pressure (hydrocephalus)
Design
Recruitment
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 |
|---|---|
| NTR-new | NL675 |
| NTR-old | NTR1377 |
| Other | Roessingh Research & Development : 08-22 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |