NCT05905198

Programming Strategy of VFS for Gait Impairments in PD

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson's Disease
• Deep Brain Stimulation
• Gait Disorders, Neurologic

Interventions

Type	Name	Description
DEVICE	Programming	programming the implanted DBS device to adjust the parameter and switch stimulation mode between Variable-Frequency settings and High-Frequency settings.

Timeline

• Start date: 2023-05-24
• Primary completion: 2023-12-31
• Completion: 2024-03-01
• First posted: 2023-06-15
• Last updated: 2023-06-15

Locations

1 site across 1 country: China