Chao Zhang
Jinan, Shandong, 250100, China
NCT Number: NCT05901350
Patients with parkinson disease (PD) usually reduced the dose the levodopa after received deep brain stimulation (DBS). However, studies seldomly mentioned about the influences on non-motors systems after the reduction. Our study focused on the changes after DBS and attribute them to the levodopa variety.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Jinan, Shandong, 250100, China
We calculated that group sample sizes of 126 patients (63 in group 1; 63 in group 2) would provide 80% power to reject the null hypothesis of equal means when the mean difference is -5(10-15) with standard deviations of 10 for test group and 10 for control group at a two-sided alpha of 0.05. Given an anticipated dropout rate of 20%, total sample size required is 158 (79 in reduction; 79 in non-reduction group).
Written informed consent was obtained from all participants. After the baseline measurement, we informed the eligible patients the assigned randomization group with sealed opaque envelopes marked with the inpatient numbers .
Within 12 months after STN-DBS, the LEDD of the intervention group was consistent with that before operation, and gradually decreased under the guidance of physician according to the expert consensus of DBS after 12 months. The compliance problem was solved by determining the actual number of antiparkinsonian medications returned by participants.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Some patients did not reduced the dose of levodopa after STN-DBS comparing to some without reducing the dose.
Time frame: 12 months after STN-DBS
The VIPD-Q scores was recorded 12 months after STN-DBS
Time frame: 12 months after STN-DBS
Time frame: 12 months after STN-DBS
Time frame: 1 months after STN-DBS
Qilu Hospital of Shandong University
Other
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