Contact information
Type
Scientific
Primary contact
Dr H.I. van Genderen
ORCID ID
Contact details
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
NTR220
Study information
Scientific title
Acronym
Study hypothesis
A single dose of fluoxetine influences muscle activation patterns and functional ability of the muscles in the lower part of the upper extremity in chronic stroke patients.
Ethics approval
Received from the local medical ethics committee
Study design
Randomised double blind placebo controlled crossover trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Ischaemic stroke
Intervention
Single administration of 20 mg of fluoxetine, or placebo.
Intervention type
Drug
Phase
Not Applicable
Drug names
Fluoxetine
Primary outcome measures
Muscle activation patterns, measured by electromyogram (EMG).
Secondary outcome measures
1. Grip strength
2. Motricity Index
3. Delay times
Overall trial start date
11/03/2004
Overall trial end date
01/11/2004
Reason abandoned
Eligibility
Participant inclusion criteria
The participating patients suffered a single ischemic stroke (confirmed by CT-scan or MRI-scan) more than six months before the start of the trial, they were over 18 years of age. Furthermore, they were able to perform some selective movements with the paretic wrist (MRC 2). And were able to follow the instructions they were given.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
10
Participant exclusion criteria
1. Patients suffering from an other neurological disease
2. Uncompensated hemineglect or cognitive disabilities, resulting in misunderstanding or incapability of executing instructions given
3. Epilepsy, or first epileptic insult post stroke
4. Patients with first grade relatives suffering epilepsy
5. Pregnancy
6. Pacemaker
7. State after irritation or lesion of median nerve
8. Implanted pumps to administer medicines
9. Metal parts inside the head
10.Cerebral aneurysm-clips (metal inside)
11. Uncontrolled medical problems
12. Alcoholism or drug-use
13. Pathological heart rhythm disorders
14. Raised intracerebral pressure (hydrocephalus)
15. External catheter
Recruitment start date
11/03/2004
Recruitment end date
01/11/2004
Locations
Countries of recruitment
Netherlands
Trial participating centre
P.O. Box 310
Enschede
7500 AH
Netherlands
Sponsor information
Organisation
Roessingh Research and Development (Netherlands)
Sponsor details
Roessingh Rehabilitation Centre
P.O. Box 310
Enschede
7500 AH
Netherlands
m.ijzerman@rrd.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Euregio - INTERREG IIIA programme (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