Effects of Cycling Deep Brain Stimulation on Parkinson's Disease Gait
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in the New Freezing of Gait Questionnaire
研究概览
简要总结
Our hypothesis is that cycling DBS stimulation would be superior or non-inferior to regular DBS stimulation in Parkinson's disease patients with gait impairment. The objective of this study is compare gait disorders in patients with Parkinson's disease and DBS in 4 different scenarios: 1) regular continuous high frequency (>130Hz) stimulation, 2) cycling high frequency (>130Hz) stimulation (40sec on, 2sec off), 3) low-frequency (80Hz) continuous stimulation and 4) cycling low frequency (80Hz) stimulation (40sec on, 2sec off)
详细描述
Gait disorders such as falls, freezing of gait, reduction of speed, shuffling, and multi-stepped turning are common in patients with moderate and advanced Parkinson's disease. Compared to appendicular symptoms (bradykinesia, tremor, and rigidity), gait disorders tend to be more resistant to medical and regular deep brain stimulation treatment, and greatly impairs patients' quality of life and daily living activities. Some stimulation strategies have been tried to improve gait in Parkinson's disease patients, but so far most of them resulted in concomitant worsening of appendicular symptoms. However, new stimulation strategies such as cycling stimulation can potentially improve gait disorders without impairment of appendicular symptoms.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic Parkinson's disease
- •Currently receiving Deep Brain Stimulation as a Parkinson's disease treatment
- •Hoehn & Yahr stage between 2-4 during off-medication
- •Underlying gait disorders despite optimal medical and stimulation treatment: score over or equal to 1 in the subitem 2.12 of the MDS-UPDRS scale
- •Willingness to comply with all study procedures
排除标准
- •Active moderate/severe psychiatric condition
- •Active infection or other uncontrolled moderate/grave comorbidities
- •Treatment with experimental drug
- •Pregnancy or breast-feeding
研究组 & 干预措施
Regular Continuous High Frequency
Patient remains 2 weeks in the currently chosen stimulation protocol.
Cycling High Frequency
Patient is stimulated with the same polarity, voltage/current, pulse width and frequency as the currently chosen stimulation protocol, but with cycling stimulation: 40sec On - 02 sec OFF
干预措施: Cycling deep brain stimulation (Other)
Continuous Low Frequency
Patient is stimulated with the same polarity and pulse width as the currently chosen stimulation protocol, but with low frequency (80Hz). Voltage/current will be adjusted to maintain TEED similar to that on the regular stimulation protocol.
干预措施: Cycling deep brain stimulation (Other)
Cycling Low Frequency
Patient is stimulated with the same polarity and pulse width as the currently chosen stimulation protocol, but with low frequency (80Hz) and cycling stimulation: 40sec On - 02 sec OFF. Voltage/current will be adjusted to maintain TEED similar to that on the regular stimulation protocol.
干预措施: Cycling deep brain stimulation (Other)
结局指标
主要结局
Change in the New Freezing of Gait Questionnaire
时间窗: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
The New Freezing of Gait Questionnaire (NFOG-Q) is a self-reportable questionnaire consisting of 9 items that measure freezing of gait (FOG). Scores vary from 0 - 28. Higher scores mean a worse outcome.
Change in the part II of the Unified Parkinson's disease rating scale
时间窗: Baseline + after 2 weeks + after 4 weeks + after 6 weeks
The part II of the Unified Parkinson's disease rating scale (UPDRS II) is a self-reportable questionnaire consisting of 13 items that measure functionality (motor experiences of daily living). Scores vary from 0 - 52. Higher scores mean a worse outcome.
次要结局
- Number of falls(Baseline + after 2 weeks + after 4 weeks + after 6 weeks)
- Change in The Parkinson's Disease Questionnaire (PDQ-39)(Baseline + after 2 weeks + after 4 weeks + after 6 weeks)
- Change in Activities-Specific Balance Confidence Scale (ABC scale)(Baseline + after 2 weeks + after 4 weeks + after 6 weeks)
- Change in Falls Efficacy Scale(Baseline + after 2 weeks + after 4 weeks + after 6 weeks)
研究者
Rubens Gisbert Cury
Principal Investigator
University of Sao Paulo General Hospital