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

NCT05901350 | Completed DMC

• 1 other identifier: Levodopa reduction after DBS
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Visual Impairment

Keywords

Deep Brain Stimulation; Levodopa

Outcome Measures

Primary Outcomes (1)

• VIPD-Q scores after STN-DBS

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

  12 months after STN-DBS

Secondary Outcomes (3)

• RNFL thickness

  12 months after STN-DBS

• Vessel density in ocular fundus

  12 months after STN-DBS

• Saccades with DBS on status

  1 months after STN-DBS

Study Arms (2)

Levodopa Reduction Group After STN-DBS

NO INTERVENTION

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

Levodopa non-Reduction Group After SNT-DBS

EXPERIMENTAL

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

Drug: Levodopa

Interventions

Levodopa DRUG

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

Levodopa non-Reduction Group After SNT-DBS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Chao Zhang

Jinan, Shandong, 250100, China

Location

MeSH Terms

Conditions

Parkinson Disease; Vision Disorders

Interventions

Levodopa

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Study Officials

• chao zhang

  Qilu Hospital of Shandong University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: June 13, 2023
• Study Start: June 1, 2019
• Primary Completion: June 1, 2022
• Study Completion: January 1, 2023
• Last Updated: July 25, 2023

Record last verified: 2019-01

Locations

CN (1)