Parkinson's disease (PD) is the neurodegenerative disease which is caused by Lewy bodies deposition in central and peripheral nervous system. The mains symptoms include both motor and non motor symptoms such as bradykinesia, rigidity, rest tremor, postural instability, autonomic dysfunction or neuropsychiatric symptoms. Moreover, the PD symptoms not only occur in the daytime, but also in the nighttime. The nighttime symptoms or nocturnal symptoms can make the patients disabling as well as the daytime symptoms. The bradykinesia that occurs in the nighttime is called nocturnal hypokinesia which also make many serious consequences such as bedsore, falling or aspiration or death. In this study, the investigators aim to study the effects of rotigotine transdermal patch compare to placebo on mainly the aspect of nocturnal hypokinesia.
The investigators recruited PD patients who had history of nocturnal hypokinesia and randomized by running number (blind) into 2 groups including active and placebo group. Baseline demographic, disease characteristics, nocturnal questionnaires and wearable nocturnal sensors data were collected before drug titration. In active group, participants received the rotigotine transdermal patch titration from 2 mg/day to maximum dosage which participants had no side effect or 16 mg/ day every week. In placebo group, participants would get the placebo patch titration as the active group. After participants got maintenance dosage, participants would get the physical examination, nocturnal questionnaires and wearable nocturnal sensors as before study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Placebo of rotigotine patch
Nocturnal parameters from wearable sensors during nighttime
The wearable sensors are the tri-axis accelerometer and gyrometer which will be attached at waist and wrist of patients up to 10 hours. The raw data from wearable sensors will be analyzed by MATLAB program. The results from MATLAB include the number of turning in bed.
Time frame: up to 10 hours
Nocturnal Akinesia Dystonia Cramp score (NADCs)
The nocturnal akinesia dystonia cramp score (NADCs) questionnaire was asked before and after participants got the interventions in both active and placebo groups.
Time frame: Before and after maintenance dosage intervention within 1 month.
PDSS-2
The Parkinson's disease sleep scale- 2 questionnaire was asked before and after participants got the interventions in both active and placebo groups.
Time frame: Before and after maintenance dosage intervention within 1 month.
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