Influence of long term administration of fluoxetine on cerebral threshold and muscle activation patterns in chronic stroke

ISRCTN ISRCTN46063747
DOI https://doi.org/10.1186/ISRCTN46063747
Secondary identifying numbers 1
Submission date
28/12/2006
Registration date
28/12/2006
Last edited
16/02/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr H I van Genderen
Scientific

Rehabilitation Centre 'The Roessingh' Enschede
P.O. Box 310
Enschede
7500 AH
Netherlands

Phone +31 (0)53 487 5765
Email h.vangenderen@rrd.nl

Study information

Study designRandomised, placebo controlled, parallel group, double blinded trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymflu2006
Study objectives1. 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(s)Approval received from the Medical Ethics committee of Medisch Spectrum Twente (Enschede, The Netherlands) on the 7th February 2007 (ref: P06-53).
Health condition(s) or problem(s) studiedStroke
Intervention20 mg of fluoxetine during 12 weeks versus placebo.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Fluoxetine
Primary outcome measure1. 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 measures1. Brain activation patterns
2. Phase synchronisation of the brain
3. Motor function
Overall study start date01/01/2007
Completion date31/12/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants28
Key inclusion criteria1. Chronic ischaemic stroke patients (more than six months after stroke)
2. Aged over 18
Key exclusion criteria1. 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
Date of first enrolment01/01/2007
Date of final enrolment31/12/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Rehabilitation Centre 'The Roessingh' Enschede
Enschede
7500 AH
Netherlands

Sponsor information

Rehabilitation Centre 'The Roessingh' Enschede (The Netherlands)
Research organisation

P.O. Box 310
Enschede
7500 AH
Netherlands

Email m.j.ijzerman@utwente.nl
Website http://www.rrd.nl/www/indexa.html
ROR logo "ROR" https://ror.org/02nmj4h80

Funders

Funder type

Research organisation

St. Jorisstichting (The Netherlands)

No information available

Ridderlijke Duitsche Order (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan