Programming Strategy of VFS for Gait Impairments in PD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-24

Study Completion Date

2024-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Parkinson's Disease Deep Brain Stimulation Gait Disorders, Neurologic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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HFS-VFS

This arm will experience HFS first during the crossover, and then VFS.

Group Type EXPERIMENTAL

Programming

Intervention Type DEVICE

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

VFS-HFS

This arm will experience VFS first during the crossover, and then HFS.

Group Type EXPERIMENTAL

Programming

Intervention Type DEVICE

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

Interventions

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Programming

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Idiopathic Parkinson's disease (according to the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease);
* 18-75 years of age;
* Hoehn \& Yahr ≤ 3 (in best OFF-medication condition)；
* Implanted bilateral subthalamic nucleus DBS for over 1 year；
* gait Impairments in OFF-medication condition；
* High Frequency Stimulation provides significant improvement；
* in OFF-medication On-stimulation condition, capable of walking ≥ 10m.

Exclusion Criteria

* mental disorder or dementia;
* Pregnant women, lactating mothers or women who are unable to take effective measures to prevent pregnancy;
* With other diseases that can affect walking distance, such as joint diseases of the lower body, spinal diseases, neuropathy, or serious heart or lung diseases;
* In severe health condition, such as diseases associated with heart or liver;
* Epilepsy;
* Lead off target;
* Unable to willingly sign Written informed Consent;
* Disagree or unable to cooperate with follow-up sessions.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No