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

July 23, 2023 updated by: Qilu Hospital of Shandong University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

338

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Jinan, Sichuan, China, 250100
        • Chao Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Study Population

Patients with PD who were willing to accept STN-DBS

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Levodopa Reduction Group After STN-DBS
Patients in this group started to reduce levodopa dose 1 months after STN-DBS
Experimental: Levodopa non-Reduction Group After SNT-DBS
Patients in this group did not reduce levodopa dose until 12 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VIPD-Q scores after STN-DBS
Time Frame: 12 months after STN-DBS
The VIPD-Q scores was recorded 12 months after STN-DBS
12 months after STN-DBS

Secondary Outcome Measures

Outcome Measure
Time Frame
Saccades with DBS on status
Time Frame: 1 months after STN-DBS
1 months after STN-DBS
RNFL thickness
Time Frame: 12 months after STN-DBS
12 months after STN-DBS
Vessel density in ocular fundus
Time Frame: 12 months after STN-DBS
12 months after STN-DBS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Investigators

  • Study Director: chao zhang, Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

June 4, 2023

First Submitted That Met QC Criteria

June 4, 2023

First Posted (Actual)

June 13, 2023

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 23, 2023

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Levodopa reduction after DBS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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