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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HFS-VFS | Experimental | This arm will experience HFS first during the crossover, and then VFS. |
|
| VFS-HFS | Experimental | This arm will experience VFS first during the crossover, and then HFS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Programming | Device | programming the implanted DBS device to adjust the parameter and switch stimulation mode between Variable-Frequency settings and High-Frequency settings. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Baseline, 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 2 months |
| Change from Baseline 5m-Timed Up and Go test Step Frequency at 4 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Guo, M.D. | Contact | 13910091280 | guoyi@pumch.cn | |
| Le Gong, Bachlor | Contact | 13209834106 | 13278884106@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Guo, M.D. | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | 100730 | China |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020233 | Gait Disorders, Neurologic |
| D009069 | Movement Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Conduct a TUG test with 5m range setting and measure the step movement and calculate the step frequency |
| 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 | 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 | 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 | 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 | 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. | 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. | Baseline, 4 months |
| D009422 | Nervous System Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |