Improving gait in Parkinson's disease using variable frequency stimulation
Programming Strategy of Variable Frequency Stimulation for Gait Impairments in Parkinson's Disease
This study is testing if different programming strategies of Variable Frequency Stimulation can help improve walking and balance in people with Parkinson's disease who have had Deep Brain Stimulation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05905198 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of Variable Frequency Stimulation (VFS) in patients with Parkinson's disease who have undergone Deep Brain Stimulation (DBS). It is a randomized, controlled, double-blinded crossover study focusing on various programming strategies of VFS to determine which is most effective in improving gait and balance disorders. Participants will be monitored over a 4-month period to assess the long-term benefits of the chosen programming strategy. The goal is to gather clinical evidence that can inform future applications of VFS in treating gait impairments associated with Parkinson's disease.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-75 with idiopathic Parkinson's disease who have undergone DBS surgery and experience gait impairments.
Not a fit: Patients with mental disorders, dementia, or other serious health conditions affecting mobility may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved gait and balance in patients with Parkinson's disease, enhancing their overall quality of life.
How similar studies have performed: Previous studies have indicated that VFS can improve major symptoms of Parkinson's disease, but this specific programming strategy is still being evaluated for its effectiveness.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing
- Peking Union Medical College Hospital — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Yi Guo, M.D. — Peking Union Medical College Hospital
- Study coordinator: Yi Guo, M.D.
- Email: guoyi@pumch.cn
- Phone: 13910091280
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.