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
1
43
7.9
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 |
---|---|---|
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.
|
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Chao Zhang | Jinan | Sichuan | China | 250100 |
Sponsors and Collaborators
- Qilu Hospital of Shandong University
Investigators
- Study Director: chao zhang, Qilu Hospital of Shandong University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier:
NCT05901350
Other Study ID Numbers:
- Levodopa reduction after DBS
First Posted:
Jun 13, 2023
Last Update Posted:
Jun 13, 2023
Last Verified:
Jan 1, 2019
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
Keywords provided by Qilu Hospital of Shandong University
Additional relevant MeSH terms: