Programming Strategy of Variable Frequency Stimulation for Gait Impairments in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change from Baseline 5m-Timed Up and Go test Time Result at 2 months.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change from Baseline 5m-Timed Up and Go test Time Result at 2 months.
时间窗: 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.
时间窗: Baseline, 4 months
Conduct a TUG test with 5m range setting and measure the time cost
次要结局
- Change from Baseline 5m-Timed Up and Go test Step Variation Coefficient at 2 months.(Baseline, 2 months)
- Change from Baseline 5m-Timed Up and Go test Length at 2 months.(Baseline, 2 months)
- Change from Baseline 5m-Timed Up and Go test Step Variation Coefficient at 4 months.(Baseline, 4 months)
- Change from Baseline 5m-Timed Up and Go test Step Length at 4 months.(Baseline, 4 months)
- Change from Baseline 5m-Timed Up and Go test Step Frequency at 2 months.(Baseline, 2 months)
- Change from Baseline 5m-Timed Up and Go test Step Frequency at 4 months.(Baseline, 4 months)
- Change from Baseline Movement Disorder Society Unified Parkinson's Disease Rating Scale part III score at 4 months.(Baseline, 4 months)
- Change from Baseline Movement Disorder Society Unified Parkinson's Disease Rating Scale part III score at 2 months.(Baseline, 2 months)