Contact information
Type
Scientific
Primary contact
Dr H I van Genderen
ORCID ID
Contact details
Rehabilitation Centre 'The Roessingh' Enschede
P.O. Box 310
Enschede
7500 AH
Netherlands
+31 (0)53 487 5765
h.vangenderen@rrd.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Acronym
flu2006
Study hypothesis
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 change
Ethics approval
Approval received from the Medical Ethics committee of Medisch Spectrum Twente (Enschede, The Netherlands) on the 7th February 2007 (ref: P06-53).
Study design
Randomised, placebo controlled, parallel group, double blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Stroke
Intervention
20 mg of fluoxetine during 12 weeks versus placebo.
Intervention type
Drug
Phase
Not Specified
Drug names
Fluoxetine
Primary outcome measures
1. Excitability of the primary motor area, measured by motor threshold and stimulus response curve
2. Muscle activation, measured by calculating Root Mean Square (RMS) during isometric and dynamic movements
Secondary outcome measures
1. Brain activation patterns
2. Phase synchronisation of the brain
3. Motor function
Overall trial start date
01/01/2007
Overall trial end date
31/12/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Chronic ischaemic stroke patients (more than six months after stroke)
2. Aged over 18
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
28
Participant exclusion criteria
1. Patients suffering from another neurological disease
2. Uncompensated hemineglect or cognitive disabilities
3. Epilepsy, or first epileptic insult post stroke
4. Patients with first grade relatives suffering from epilepsy
5. Pregnancy
6. Pacemaker
7. Pathological heart rhythms disorders
8. Use of anti-depressants
Recruitment start date
01/01/2007
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Rehabilitation Centre 'The Roessingh' Enschede
Enschede
7500 AH
Netherlands
Sponsor information
Organisation
Rehabilitation Centre 'The Roessingh' Enschede (The Netherlands)
Sponsor details
P.O. Box 310
Enschede
7500 AH
Netherlands
m.j.ijzerman@utwente.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
St. Jorisstichting (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ridderlijke Duitsche Order (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary