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Influence of a single dose of fluoxetine on brain activity during movement observation and execution, muscle activity and motor function in chronic stroke patients


- candidate number3621
- NTR NumberNTR1377
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jul-2008
- Secondary IDs08-22 Roessingh Research & Development
- Public TitleInfluence of a single dose of fluoxetine on brain activity during movement observation and execution, muscle activity and motor function in chronic stroke patients
- Scientific TitleInfluence of a single dose of fluoxetine on brain activity during movement observation and execution, muscle activity and motor function in chronic stroke patients
- ACRONYMflu2008
- hypothesisFluoxetine and movement observation are able to increase cortical activity after stroke
- Healt Condition(s) or Problem(s) studiedStroke, Stroke, Fluoxetine, Brain activity
- Inclusion criteria1. 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 criteria1. Other (pre-existing) neurological diseases (e.g. epilepsy, tumor, paralysis)
2. Known allergy to SSRIís
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)
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2008
- planned closingdate1-jul-2009
- Target number of participants20
- InterventionsThe 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.
- Primary outcome- EEG after fluoxetine intake and during movement observation
- Secondary outcome- Fugl-Meyer motor assessment, EMG, force production
- TimepointsMeasurements are two weeks apart
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. H.I. Genderen, van
- CONTACT for SCIENTIFIC QUERIESDrs. H.I. Genderen, van
- Sponsor/Initiator Roessingh Research and Development
- Funding
(Source(s) of Monetary or Material Support)
Interreg Euregio
- PublicationsN/A
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD14-jul-2008 - 3-aug-2008


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