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

Sponsor

Qilu Hospital of Shandong University (Other)

Overall Status

Completed

CT.gov ID

NCT05901350

Collaborator

(none)

338

Enrollment

Location

Actual Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease Visual Impairment	Drug: Levodopa

Study Design

Study Type:

Observational

Actual Enrollment :

338 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2019

Actual Primary Completion Date :

Jun 1, 2022

Actual Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Levodopa Reduction Group After STN-DBS Patients in this group started to reduce levodopa dose 1 months after STN-DBS
Levodopa non-Reduction Group After SNT-DBS Patients in this group did not reduce levodopa dose until 6 months after STN-DBS	Drug: Levodopa Some patients did not reduced the dose of levodopa after STN-DBS comparing to some without reducing the dose.

Arm

Intervention/Treatment

Levodopa Reduction Group After STN-DBS

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

Levodopa non-Reduction Group After SNT-DBS

Patients in this group did not reduce levodopa dose until 6 months after STN-DBS

Drug: Levodopa

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

Outcome Measures

Primary Outcome Measures

VIPD-Q scores after STN-DBS [6 months after STN-DBS]
The VIPD-Q scores was recorded 6 months after STN-DBS

Secondary Outcome Measures

RNFL thickness [6 months after STN-DBS]
Vessel density in ocular fundus [6 months after STN-DBS]
Saccades with DBS on status [1 months after STN-DBS]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.