- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01554306
Measuring the Effects of Continuous Dopaminergic Stimulation on Nocturnal Movements in Parkinson's Disease
Observational Study on the Effecst of Continuous Dopaminergic Stimulation on Nocturnal Hypokinesia in Parkinson's Disease
Parkinson's disease (PD) is a neurodegenerative disorder that is characterized with motor symptoms such as hypokinesia, rigidity, tremor and postural instability. These symptoms can also be present during the night. Half of the patients with PD have difficulty turning around in bed. This nocturnal hypokinesia is considered as a possible cause of sleep problems in this population. The diagnosis nocturnal hypokinesia is based on the clinical interview. There is a need for a diagnostic devices that measures nocturnal movements, preferably in the home setting. This device can be used in the diagnostic trajectory as well in the evaluation of treatment. Recently the Dynaport Minimod (McRoberts, The Hague) has been developed to register nocturnal movements. The tri-axial accelerometer has been developed to measure position changes in the night. A validation study with actigraphy and polysomnography concluded that the Dynaport MiniMod is a valid an feasible device for assessing intensity and physical activity and changes of body position during sleep.
Nocturnal hypokinesia is treated with nocturnal dopamine. Sometimes a night-time dose of dopaminergics is adequate, but most of the time slow release dopaminergics are needed. However response fluctuations can negatively influence the treatment. In these cases continuous dopaminergic stimulation is needed, such as rotigotine. Rotigotine treats response fluctuations during the day and studies show that sleep quality measured with questionnaires improves. If the improvement of sleep quality is caused by improved bed mobility has not been studied yet. The study hypothesis is that rotigotine does not influence nocturnal hypokinesia in PD.
Objective of the study:
Primary:
• To study the effect of rotigotine on nocturnal hypokinesia
Secondary:
- To study the possibility of measuring nocturnal hypokinesia and its severity in a home setting
- To correlate improvements in sleep quality by rotigotine with changes in nocturnal hypokinesia
Study design:
We will study patients who will recieve rotigotine as a part of their usual care. During three nights, nocturnal movements are being registered with movement sensors, before treatment has started as well as after a stable medication dose of one month. We will also assess sleep quality with questionnaires.
Study population:
The study population are patients with Parkinson's disease with sleep problems caused by nocturnal hypokinesia, who will start treatment with rotigotine. Patients will be recruited in the neurology patient outdoor clinic of the Radboud University Medical Centre Nijmegen. We will ask the treating neurologist to inform us when a patient will start treatment with rotigotine. One of the researchers will contact the patient to give further information about the study. The study is a first hypothesis generating study and we will start with the inclusion of 10 patients.
Intervention (if applicable):
Primary study parameters/outcome of the study:
Position changes over the night.
Secundary study parameters/outcome of the study (if applicable):
Objective
- Degree of mobility, measured as the speed of the movements
- Total amount of movements
- Score on the motor symptom scale according to the MDS-UPDRS part III
Subjective
- Nocturnal sleep quality Excessive daytime sleepiness
- Presence of nocturnal akinesia
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Heeze, Netherlands, 5591 VE
- Sleep Medicine Centre Kempenhaeghe
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with idiopathic PD (defined by UK Brain Bank criteria)
- Patients who will start treatment with rotigotine
- Hoehn & Yahr stage II - IV
- Subjective sleep problems most likely caused by nocturnal hypokinesia, based on clinical interview
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
parkinson's disease, nocturnal hypokinesia, rotigotine
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Position changes over the night.
Time Frame: max 1 year
|
max 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
• Degree of mobility, measured as the speed of the movements
Time Frame: Max 1 year
|
Max 1 year
|
• Total amount of movements
Time Frame: Max 1 year
|
Max 1 year
|
• Score on the motor symptom scale according to the MDS-UPDRS part III
Time Frame: Max 1 year
|
Max 1 year
|
Collaborators and Investigators
Investigators
- Study Director: Dirk AA Pevernagie, MD PhD, Sleep Medicine Centre Kempenhaeghe
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38851.091.11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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