The Correlation of Reduction of Levodopa and Non-motor Symptoms of Parkinson's Disease After Deep Brain Stimulation

NCT ID: NCT05901350

Last Updated: 2023-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 338 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2023-01-01

Brief Summary

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.

Detailed Description

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.

Conditions

Parkinson Disease; Visual Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Levodopa Reduction Group After STN-DBS

Patients in this group started to reduce levodopa dose 1 months after STN-DBS

Group Type: NO_INTERVENTION

No interventions assigned to this group

Levodopa non-Reduction Group After SNT-DBS

Patients in this group did not reduce levodopa dose until 12 months after STN-DBS

Group Type: EXPERIMENTAL

Levodopa

Intervention Type: DRUG

Some patients did not reduced the dose of levodopa after STN-DBS comparing to some without reducing the dose.

Interventions

Levodopa

Some patients did not reduced the dose of levodopa after STN-DBS comparing to some without reducing the dose.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants underwent neuro-ophthalmologic examinations, including ocular fundus photography, automated perimetry, and OCT. Patients undergoing deep brain stimulation (DBS) took an extra VIPD-Q after the operation.

Exclusion Criteria

• secondary causes of parkinsonism, prior brain surgery (except DBS), glaucoma, intraocular surgery, diabetes and other diseases affecting the visual field or neurologic systems, and the current use of medications affecting visual function.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

chao zhang

Role: STUDY_DIRECTOR

Qilu Hospital of Shandong University

Locations

Chao Zhang

Jinan, Shandong, China

Countries

China

Other Identifiers

Levodopa reduction after DBS

Identifier Type: -

Identifier Source: org_study_id