Condition category
Circulatory System
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
15/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.rrd.nl/

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

Publication citations

Additional files

Editorial Notes