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ISRCTN
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ISRCTN46063747
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ClinicalTrials.gov identifier
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Public title
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Influence of long term administration of fluoxetine on cerebral threshold and muscle activation patterns in chronic stroke
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Scientific title
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Acronym
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flu2006
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Serial number at source
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1
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Study hypothesis
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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
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Lay summary
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Ethics approval
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Approval received from the Medical Ethics committee of Medisch Spectrum Twente (Enschede, The Netherlands) on the 7th February 2007 (ref: P06-53).
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Study design
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Randomised, placebo controlled, parallel group, double blinded trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Stroke
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Participants - inclusion criteria
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1. Chronic ischaemic stroke patients (more than six months after stroke)
2. Aged over 18
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Participants - exclusion criteria
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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
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Anticipated start date
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01/01/2007
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Anticipated end date
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31/12/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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28
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Interventions
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20 mg of fluoxetine during 12 weeks versus placebo.
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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1. Brain activation patterns
2. Phase synchronisation of the brain
3. Motor function
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Sources of funding
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1. St. Jorisstichting (The Netherlands)
2. Ridderlijke Duitsche Order (The Netherlands)
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Trial website
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Publications
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Contact name
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Dr
H I
van Genderen
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Address
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Rehabilitation Centre 'The Roessingh' Enschede
P.O. Box 310
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City/town
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Enschede
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Zip/Postcode
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7500 AH
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Country
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Netherlands
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Tel
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+31 (0)53 487 5765
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Fax
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+31 (0)53 434 0849
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Email
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h.vangenderen@rrd.nl
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Sponsor
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Rehabilitation Centre 'The Roessingh' Enschede (The Netherlands)
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Address
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P.O. Box 310
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City/town
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Enschede
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Zip/Postcode
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7500 AH
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Country
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Netherlands
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Email
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m.j.ijzerman@utwente.nl
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Sponsor website:
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http://www.rrd.nl/www/indexa.html
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Date applied
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28/12/2006
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Last edited
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16/02/2007
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Date ISRCTN assigned
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28/12/2006
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