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Programming Strategy of VFS for Gait Impairments in PD

NCT05905198 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-06-15

No results posted yet for this study

Summary

Variable Frequency Stimulation(VFS) is a stimulation pattern applied in Deep Brain Stimulation(DBS) therapy for Parkinson's disease(PD). Peking Union Medical College Hospital was the first centre conducting research on VFS. The studies in the past have resembled conclusion that VFS provides improvement not only in the major symptoms such as tremor and rigidity, but also in gait and balance disorder. However, the best programming strategy of VFS has not met agreement. The random-controlled double blinded crossover study is designed for participants who underwent DBS surgery in bilateral subthalamic nucleus for parkinson's disease. The investigators study several strategies on programming and observe the improvement of symptom to look for the best one. A 4-month follow-up is designed to observe a relatively long-term effectiveness of VFS. The study intends to gather more clinical evidence to guide further studies on VFS application.

Conditions

Interventions

DEVICE

Programming

programming the implanted DBS device to adjust the parameter and switch stimulation mode between Variable-Frequency settings and High-Frequency settings.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Yi Guo, M.D. · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-24
Primary Completion
2023-12-31
Completion
2024-03-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05905198 on ClinicalTrials.gov