Parkinson's DiseaseNCT05905198
Programming Strategy of VFS for Gait Impairments in PD
A study testing Programming in people with Parkinson's Disease and Deep Brain Stimulation, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson's Disease, Deep Brain Stimulation, Gait Disorders, Neurologic
- What is being tested?
- Programming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Yi Guo, M.D., 13910091280, guoyi@pumch.cn
About this study
Official title: 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.
- Being tested
- Programming
- Keywords
- Parkinson's disease, Deep brain stimulation, Variable frequency stimulation, Movement disorder, Freezing of gait, Crossover study
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgrammingDevice
programming the implanted DBS device to adjust the parameter and switch stimulation mode between Variable-Frequency settings and High-Frequency settings.
| Study group | Role | What they receive |
|---|---|---|
| HFS-VFS | Experimental | This arm will experience HFS first during the crossover, and then VFS. Receives: Device: Programming |
| VFS-HFS | Experimental | This arm will experience VFS first during the crossover, and then HFS. Receives: Device: Programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 2 months
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
Measured: Baseline, 4 months
Secondary outcomes (8)
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
Measured: Baseline, 2 months
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
Measured: Baseline, 4 months
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
Measured: Baseline, 2 months
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
Measured: Baseline, 4 months
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
Measured: Baseline, 2 months
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
Measured: Baseline, 4 months
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.
Measured: Baseline, 2 months
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.
Measured: Baseline, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start24 May 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Guo, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905198
- Sponsor's protocol ID
- K3438
- Status last verified
- Jun 2023
- First submitted
- 22 Feb 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programming Strategy of Variable Frequency Stimulation for Gait Impairments in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05905198
- Acronym / sponsor ID
- K3438
- Keywords
- Parkinson's disease, Deep brain stimulation, Variable frequency stimulation, Movement disorder, Freezing of gait, Crossover study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 24 May 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFS-VFS | Experimental | Device: ProgrammingThis arm will experience HFS first during the crossover, and then VFS. |
| VFS-HFS | Experimental | Device: ProgrammingThis arm will experience VFS first during the crossover, and then HFS. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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；
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Programmingprogramming the implanted DBS device to adjust the parameter and switch stimulation mode between Variable-Frequency settings and High-Frequency settings. | Device | HFS-VFS, VFS-HFS |
Primary outcome
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
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
8 secondary outcomes
Change from Baseline 5m-Timed Up and Go test Step Frequency at 2 months.
Time frame: Baseline, 2 months
Change from Baseline 5m-Timed Up and Go test Step Frequency at 4 months.
Time frame: Baseline, 4 months
Change from Baseline 5m-Timed Up and Go test Length at 2 months.
Time frame: Baseline, 2 months
Change from Baseline 5m-Timed Up and Go test Step Length at 4 months.
Time frame: Baseline, 4 months
Change from Baseline 5m-Timed Up and Go test Step Variation Coefficient at 2 months.
Time frame: Baseline, 2 months
Change from Baseline 5m-Timed Up and Go test Step Variation Coefficient at 4 months.
Time frame: 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
Change from Baseline Movement Disorder Society Unified Parkinson's Disease Rating Scale part III score at 4 months.
Time frame: Baseline, 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Guo, M.D. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Programming in people with Parkinson's Disease and Deep Brain Stimulation, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Guo, M.D. (13910091280, guoyi@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline 5m-Timed Up and Go test Time Result at 2 months. (time frame: Baseline, 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023; AzTrials last refreshed its copy on 7 Nov 2026.