Automated Mechanical Peripheral Stimulation to Treat Freezing of Gait in Patients With Parkinson's Disease and Subthalamic Nucleus Deep Brain Stimulation (STN-DBS) - a Randomized Double-blind, Sham Controlled, Cross-over Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Freezing of gait assessment course
研究概览
简要总结
The objective is to investigate whether AMPS (Automated Mechanical Peripheral Stimulation) is effective in reduction of FOG measured via the FOG-AC (Freezing Of Gait Assessment Course) in people with Parkinson Disease and STN-DBS (Subthalamic Nucleus Deep Brain Stimulation) in a randomized, double-blind, sham-controlled, cross-over trial
详细描述
The effects of AMPS treatment (effective vs sham) will be measured using the FOG-AC assessment. Patients will be randomized to receive either AMPS treatment and then sham or sham and then AMPS. Each treatment phase will be 4 weeks of treatment, separated by a 6-week washout period.
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, Investigator, 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
- •Informed Consent as documented by signature (Appendix Informed Consent Form)
- •≥18 years old
- •Diagnosis of Parkinson's Disease according to the United Kingdom Brain Bank Criteria
- •Bilateral STN-DBS for at least 6 months
- •Moderate to severe FOG i.e. FOG-AC ≥8 pts.
排除标准
- •Known or suspected non-compliance, drug or alcohol abuse,
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, etc. of the participant,
- •Participation in another study with investigational drug within the 30 days preceding and during the present study,
- •Previous enrolment into the current study,
- •Pregnancy
- •Enrolment of the investigator, his/her family members, employees and other dependent persons,
- •L-Dopa induced-freezing (defined by medical history),
- •DBS-induced freezing (defined by medical history),
- •Clinically relevant depression
- •Clinically relevant cognitive impairments
- •Shoe size greater than 46
结局指标
主要结局
Freezing of gait assessment course
时间窗: 4 weeks
The primary outcome is the change in FOG severity measured by the freezing of gait assessment course (FOG-AC) and evaluated by a blinded observer using video recordings (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment). Min: 0 Max: 36 Higher score indicates worse symptoms.
次要结局
- Freezing of Gait Questionnaire(4 weeks)
- Movement Disorder Society - Unified Parkinson's Disease Rating Scale part I-IV(4 weeks)
- Parkinson's Disease Questionnaire(4 weeks)
- Clinical Global Impression Severity and Improvement Scores(4 weeks)
- Timed up and go test(4 weeks)
- Falls Efficacy Scale - International(4 weeks)
- Fast 360° turns(4 weeks)
- 30-meter walk(4 weeks)