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

Primary Purpose

Parkinson Disease, Visual Impairment

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Levodopa

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Deep Brain Stimulation, Levodopa

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Chao Zhang

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Levodopa Reduction Group After STN-DBS

Levodopa non-Reduction Group After SNT-DBS

Arm Description

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

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

Outcomes

Primary Outcome Measures

VIPD-Q scores after STN-DBS

The VIPD-Q scores was recorded 12 months after STN-DBS

Secondary Outcome Measures

RNFL thickness

Vessel density in ocular fundus

Saccades with DBS on status

Full Information

NCT ID

NCT05901350

First Posted

June 4, 2023

Last Updated

July 23, 2023

Sponsor

Qilu Hospital of Shandong University

1. Study Identification

Unique Protocol Identification Number

NCT05901350

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

June 1, 2019 (Actual)

Primary Completion Date

June 1, 2022 (Actual)

Study Completion Date

January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Qilu Hospital of Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease, Visual Impairment

Keywords

Deep Brain Stimulation, Levodopa

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

338 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Levodopa Reduction Group After STN-DBS

Arm Type

No Intervention

Arm Description

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

Arm Title

Levodopa non-Reduction Group After SNT-DBS

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Levodopa

Intervention Description

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

Primary Outcome Measure Information:

Title

VIPD-Q scores after STN-DBS

Description

The VIPD-Q scores was recorded 12 months after STN-DBS

Time Frame

12 months after STN-DBS

Secondary Outcome Measure Information:

Title

RNFL thickness

Time Frame

12 months after STN-DBS

Title

Vessel density in ocular fundus

Time Frame

12 months after STN-DBS

Title

Saccades with DBS on status

Time Frame

1 months after STN-DBS

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

chao zhang

Organizational Affiliation

Qilu Hospital of Shandong University

Official's Role

Study Director

Facility Information:

Facility Name

Chao Zhang

City

Jinan

State/Province

Sichuan

ZIP/Postal Code

250100

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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