Programming Strategy of VFS for Gait Impairments in PD (NCT05905198) | Clinical Trial Compass
UnknownNot Applicable
Programming Strategy of VFS for Gait Impairments in PD
China30 participantsStarted 2023-05-24
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline 5m-Timed Up and Go test Time Result at 2 months.
Timeframe: Baseline, 2 months
2
Change from Baseline 5m-Timed Up and Go test Time Result at 4 months.