Measuring the Effects of Continuous Dopaminergic Stimulation on Nocturnal Movements in Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT01554306|
Recruitment Status : Terminated (difficulty to include enough subjects)
First Posted : March 14, 2012
Last Update Posted : October 31, 2016
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:
• To study the effect of rotigotine on nocturnal hypokinesia
- 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
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.
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):
- 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
- Nocturnal sleep quality Excessive daytime sleepiness
- Presence of nocturnal akinesia
|Condition or disease|
|Nocturnal Hypokinesia Parkinsons's Disease Rotigotine|
|Study Type :||Observational|
|Actual Enrollment :||2 participants|
|Official Title:||Observational Study on the Effecst of Continuous Dopaminergic Stimulation on Nocturnal Hypokinesia in Parkinson's Disease|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
|parkinson's disease, nocturnal hypokinesia, rotigotine|
- Position changes over the night. [ Time Frame: max 1 year ]
- • Degree of mobility, measured as the speed of the movements [ Time Frame: Max 1 year ]
- • Total amount of movements [ Time Frame: Max 1 year ]
- • Score on the motor symptom scale according to the MDS-UPDRS part III [ Time Frame: Max 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01554306
|Sleep Medicine Centre Kempenhaeghe|
|Heeze, Netherlands, 5591 VE|
|Study Director:||Dirk AA Pevernagie, MD PhD||Sleep Medicine Centre Kempenhaeghe|