Measuring the effects of continuous dopaminergic stimulation on nocturnal movements in Parkinson's disease.
Phase 4
Recruiting
- Conditions
- difficulty turning around in bednocturnal hypokinesia10040998
- Registration Number
- NL-OMON35536
- Lead Sponsor
- Centrum voor Slaapgeneeskunde Kempenhaeghe
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
Patients with idiopathic PD
Patients who will start treatment with rotigotine
Hoehn & Yahr stage II - IV
Subjective sleep problems most likely caused by nocturnal hypokinesia
Exclusion Criteria
Other significant causes for nocturnal motor symptoms which are not dopamine-responsive
Previous surgery for PD
Mini- mental state examination score < 25
Concurrent hallucination or psychosis
History of skin hypersensitivity to adhesives or other transdermals
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Position changes over the night. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Objective<br /><br>• Degree of mobility, measured as the speed of the movements<br /><br>• Total amount of movements<br /><br>• Score on the motor symptom scale according to the MDS-UPDRS part III<br /><br><br /><br>Subjective<br /><br>• Nocturnal sleep quality<br /><br>Excessive daytime sleepiness<br /><br>• Presence of nocturnal akinesia </p><br>