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
Scientific
Rehabilitation Centre 'The Roessingh' Enschede
P.O. Box 310
Enschede
7500 AH
Netherlands
| Phone | +31 (0)53 487 5765 |
|---|---|
| h.vangenderen@rrd.nl |
Study information
| Study design | Randomised, placebo controlled, parallel group, double blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | flu2006 |
| Study objectives | 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(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) studied | Stroke |
| Intervention | 20 mg of fluoxetine during 12 weeks versus placebo. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Fluoxetine |
| Primary outcome measure | 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 study start date | 01/01/2007 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 28 |
| Key inclusion criteria | 1. Chronic ischaemic stroke patients (more than six months after stroke) 2. Aged over 18 |
| Key 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 |
| Date of first enrolment | 01/01/2007 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Rehabilitation Centre 'The Roessingh' Enschede
Enschede
7500 AH
Netherlands
7500 AH
Netherlands
Sponsor information
Rehabilitation Centre 'The Roessingh' Enschede (The Netherlands)
Research organisation
Research organisation
P.O. Box 310
Enschede
7500 AH
Netherlands
| m.j.ijzerman@utwente.nl | |
| Website | http://www.rrd.nl/www/indexa.html |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
