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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05901350
• Other study ID #: Levodopa reduction after DBS
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: January 1, 2023

Study information

• Verified date: January 2019
• Source: Qilu Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: January 1, 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

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

Locations

Country	Name	City	State
China	Chao Zhang	Jinan	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VIPD-Q scores after STN-DBS	The VIPD-Q scores was recorded 12 months after STN-DBS	12 months after STN-DBS
Secondary	RNFL thickness		12 months after STN-DBS
Secondary	Vessel density in ocular fundus		12 months after STN-DBS
Secondary	Saccades with DBS on status		1 months after STN-DBS