Parkinsons's Disease Clinical Trial
Official title:
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
n/a
Observational Model: Case-Only, Time Perspective: Prospective
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