Programming Strategy of VFS for Gait Impairments in PD

June 7, 2023 updated by: Peking Union Medical College Hospital

Programming Strategy of Variable Frequency Stimulation for Gait Impairments in Parkinson's Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HFS-VFS
This arm will experience HFS first during the crossover, and then VFS.
Device: Programming
programming the implanted DBS device to adjust the parameter and switch stimulation mode between Variable-Frequency settings and High-Frequency settings.
Experimental: VFS-HFS
This arm will experience VFS first during the crossover, and then HFS.
Device: Programming
programming the implanted DBS device to adjust the parameter and switch stimulation mode between Variable-Frequency settings and High-Frequency settings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline 5m-Timed Up and Go test Time Result at 2 months.
Time Frame: Baseline, 2 months
Conduct a TUG test with 5m range setting and measure the time cost
Baseline, 2 months
Change from Baseline 5m-Timed Up and Go test Time Result at 4 months.
Time Frame: Baseline, 4 months
Conduct a TUG test with 5m range setting and measure the time cost
Baseline, 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline 5m-Timed Up and Go test Step Frequency at 2 months.
Time Frame: Baseline, 2 months
Conduct a TUG test with 5m range setting and measure the step movement and calculate the step frequency
Baseline, 2 months
Change from Baseline 5m-Timed Up and Go test Step Frequency at 4 months.
Time Frame: Baseline, 4 months
Conduct a TUG test with 5m range setting and measure the step movement and calculate the step frequency
Baseline, 4 months
Change from Baseline 5m-Timed Up and Go test Length at 2 months.
Time Frame: Baseline, 2 months
Conduct a TUG test with 5m range setting and measure the length of each step
Baseline, 2 months
Change from Baseline 5m-Timed Up and Go test Step Length at 4 months.
Time Frame: Baseline, 4 months
Conduct a TUG test with 5m range setting and measure the length of each step
Baseline, 4 months
Change from Baseline 5m-Timed Up and Go test Step Variation Coefficient at 2 months.
Time Frame: Baseline, 2 months
Conduct a TUG test with 5m range setting and use the length of each step to calculate the difference coefficient
Baseline, 2 months
Change from Baseline 5m-Timed Up and Go test Step Variation Coefficient at 4 months.
Time Frame: Baseline, 4 months
Conduct a TUG test with 5m range setting and use the length of each step to calculate the difference coefficient
Baseline, 4 months
Change from Baseline Movement Disorder Society Unified Parkinson's Disease Rating Scale part III score at 2 months.
Time Frame: Baseline, 2 months
Conduct a Movement Disorder Society Unified Parkinson's Disease Rating Scale survey and record the score. Higher MDS UPDRS III score represents worse movement disorder symptoms.
Baseline, 2 months
Change from Baseline Movement Disorder Society Unified Parkinson's Disease Rating Scale part III score at 4 months.
Time Frame: Baseline, 4 months
Conduct a Movement Disorder Society Unified Parkinson's Disease Rating Scale survey and record the score. Higher MDS UPDRS III score represents worse movement disorder symptoms.
Baseline, 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Yi Guo, M.D., Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

February 22, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 7, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K3438

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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