Back to resultsProgramming Strategy of VFS for Gait Impairments in PD
Primary Purpose
Parkinson's Disease, Deep Brain Stimulation, Gait Disorders, Neurologic
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Programming
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Deep brain stimulation, Variable frequency stimulation, Movement disorder, Freezing of gait, Crossover study
Eligibility Criteria
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.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
HFS-VFS
VFS-HFS
Arm Description
This arm will experience HFS first during the crossover, and then VFS.
This arm will experience VFS first during the crossover, and then HFS.
Outcomes
Primary Outcome Measures
Change from Baseline 5m-Timed Up and Go test Time Result at 2 months.
Conduct a TUG test with 5m range setting and measure the time cost
Change from Baseline 5m-Timed Up and Go test Time Result at 4 months.
Conduct a TUG test with 5m range setting and measure the time cost
Secondary Outcome Measures
Change from Baseline 5m-Timed Up and Go test Step Frequency at 2 months.
Conduct a TUG test with 5m range setting and measure the step movement and calculate the step frequency
Change from Baseline 5m-Timed Up and Go test Step Frequency at 4 months.
Conduct a TUG test with 5m range setting and measure the step movement and calculate the step frequency
Change from Baseline 5m-Timed Up and Go test Length at 2 months.
Conduct a TUG test with 5m range setting and measure the length of each step
Change from Baseline 5m-Timed Up and Go test Step Length at 4 months.
Conduct a TUG test with 5m range setting and measure the length of each step
Change from Baseline 5m-Timed Up and Go test Step Variation Coefficient at 2 months.
Conduct a TUG test with 5m range setting and use the length of each step to calculate the difference coefficient
Change from Baseline 5m-Timed Up and Go test Step Variation Coefficient at 4 months.
Conduct a TUG test with 5m range setting and use the length of each step to calculate the difference coefficient
Change from Baseline Movement Disorder Society Unified Parkinson's Disease Rating Scale part III score at 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.
Change from Baseline Movement Disorder Society Unified Parkinson's Disease Rating Scale part III score at 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.
Full Information
NCT ID
NCT05905198
First Posted
February 22, 2023
Last Updated
June 7, 2023
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05905198
Brief Title
Programming Strategy of VFS for Gait Impairments in PD
Official Title
Programming Strategy of Variable Frequency Stimulation for Gait Impairments in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Deep Brain Stimulation, Gait Disorders, Neurologic
Keywords
Parkinson's disease, Deep brain stimulation, Variable frequency stimulation, Movement disorder, Freezing of gait, Crossover study
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HFS-VFS
Arm Type
Experimental
Arm Description
This arm will experience HFS first during the crossover, and then VFS.
Arm Title
VFS-HFS
Arm Type
Experimental
Arm Description
This arm will experience VFS first during the crossover, and then HFS.
Intervention Type
Device
Intervention Name(s)
Programming
Intervention Description
programming the implanted DBS device to adjust the parameter and switch stimulation mode between Variable-Frequency settings and High-Frequency settings.
Primary Outcome Measure Information:
Title
Change from Baseline 5m-Timed Up and Go test Time Result at 2 months.
Description
Conduct a TUG test with 5m range setting and measure the time cost
Time Frame
Baseline, 2 months
Title
Change from Baseline 5m-Timed Up and Go test Time Result at 4 months.
Description
Conduct a TUG test with 5m range setting and measure the time cost
Time Frame
Baseline, 4 months
Secondary Outcome Measure Information:
Title
Change from Baseline 5m-Timed Up and Go test Step Frequency at 2 months.
Description
Conduct a TUG test with 5m range setting and measure the step movement and calculate the step frequency
Time Frame
Baseline, 2 months
Title
Change from Baseline 5m-Timed Up and Go test Step Frequency at 4 months.
Description
Conduct a TUG test with 5m range setting and measure the step movement and calculate the step frequency
Time Frame
Baseline, 4 months
Title
Change from Baseline 5m-Timed Up and Go test Length at 2 months.
Description
Conduct a TUG test with 5m range setting and measure the length of each step
Time Frame
Baseline, 2 months
Title
Change from Baseline 5m-Timed Up and Go test Step Length at 4 months.
Description
Conduct a TUG test with 5m range setting and measure the length of each step
Time Frame
Baseline, 4 months
Title
Change from Baseline 5m-Timed Up and Go test Step Variation Coefficient at 2 months.
Description
Conduct a TUG test with 5m range setting and use the length of each step to calculate the difference coefficient
Time Frame
Baseline, 2 months
Title
Change from Baseline 5m-Timed Up and Go test Step Variation Coefficient at 4 months.
Description
Conduct a TUG test with 5m range setting and use the length of each step to calculate the difference coefficient
Time Frame
Baseline, 4 months
Title
Change from Baseline Movement Disorder Society Unified Parkinson's Disease Rating Scale part III score at 2 months.
Description
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.
Time Frame
Baseline, 2 months
Title
Change from Baseline Movement Disorder Society Unified Parkinson's Disease Rating Scale part III score at 4 months.
Description
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.
Time Frame
Baseline, 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Guo, M.D.
Phone
13910091280
Email
guoyi@pumch.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Le Gong, Bachlor
Phone
13209834106
Email
13278884106@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Guo, M.D.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Guo, M.D.
Phone
13910091280
Email
guoyi@pumch.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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Programming Strategy of VFS for Gait Impairments in PD
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