Double-Blind Trial of Variable Frequency Stimulation for Freezing of Gait in Parkinson's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- the number of freezing episodes for TUG task
研究概览
简要总结
This is the first study on the effect of the variable frequency stimulation (VFS) on Freezing of gait (FOG) in Parkinson's disease (PD) patients with STN DBS. FOG has responded poorly to High frequency stimulation (HFS) but can be alleviated by relatively VFS. This study would have significant clinical implications in the management of Freezing of gait (FOG) in these PD patients with subthalamic nucleus (STN) DBS. The investigators hypothesize that VFS could have better effect on FOG than HFS and low frequency stimulation (LFS).
详细描述
HFS of STN provides consistent, long-term improvement of the cardinal motor signs of PD, such as bradykinesia, tremor and rigidity. FOG has responded poorly to HFS and tends to continue to deteriorate over time, but this can be alleviated by relatively LFS. Evidence has indicated that LFS-STN can improve axial signs in some but not all PD patients, but most of them experienced loss of efficacy in the short term. Then comes to the little improvement or even worse of tremor, rigidity and bradykinesia, which consists of the three main symptoms of Parkinson's disease. Thus even if axial problems could be solved by LFS in a long way, it could also be hard to tolerate by those patients. The effect of VFS on FOG will be studied. The investigators hypothesize that VFS could have better effect on Freezing of gait than HFS and LFS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients were receiving bilateral STN stimulation for more than six months.
- •They were optimized on conventional HFS for control of tremors, rigidity and bradykinesia yet complained of freezing of gait.
- •Subjects had an ability to walk at least 10 meters independently during ON DBS condition.
排除标准
- •gait disorders perceived by patients as a direct consequence of STN stimulation and not the primary disease.
- •any change in the HFS DBS settings, three months prior to participation in the study.
- •complete inability to walk despite assistance while DBS ON.
- •Subjects responding to reprogramming of chronic DBS settings (report improvement of freezing).
- •Subjects could not tolerate prolonged OFF medication condition.
研究组 & 干预措施
VFS
variable frequency deep brain stimulation (VFS)
干预措施: Deep Brain Stimulation (Device)
HFS
high frequency deep brain stimulation (HFS)
干预措施: Deep Brain Stimulation (Device)
LFS
low frequency deep brain stimulation (LFS)
干预措施: Deep Brain Stimulation (Device)
DBS off
deep brain stimulation off
结局指标
主要结局
the number of freezing episodes for TUG task
时间窗: The outcome of TUG task at 12 months follow-up.
variable frequency stimulation (VFS) setting compared to high frequency stimulation (HFS) and low frequency stimulation (LFS)
Timed Up and Go (TUG) task
时间窗: The outcome of TUG task at 12 months follow-up.
variable frequency stimulation (VFS) setting compared to high frequency stimulation (HFS) and low frequency stimulation (LFS)
次要结局
- Number of adverse events (AE's)(Change from Baseline to 6、12 Months)
- UPDRS III scores(Outcome of VFS at 6、12 months with reference to baseline HFS)
- the Freezing of Gait Questionnaire (FOG-Q) scores(Outcome of VFS at 6 、12months with reference to baseline HFS)
- Gait and Falls Questionnaire (GFQ) scores(Outcome of VFS at 6、12 months with reference to baseline HFS)
- the39-item Parkinson's Disease Questionnaire (PDQ-39) scores(Outcome of VFS at 6、12 months with reference to baseline HFS)