Spinal Cord Stimulation to Reduce Imbalance and Falls in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Number of Participants with Incidence of Serious Adverse Events
研究概览
简要总结
Parkinson's disease (PD) is the second commonest neurodegenerative disorder, affecting over 145,000 people in the UK. Initially, PD patients experience slowness of movements, limb stiffness, and tremor.
With progressive loss of neurons over time, many patients start to experience balance and walking problems, and falls, which are resistant to currently available treatments. Falls can lead to fractures and nursing home admission, and can significantly shorten patients' life expectancy.
In this pilot study, the investigators will investigate the effects of spinal cord stimulation (SCS) on gait and balance in PD. Some open-labelled studies have shown possible beneficial effects of SCS in PD, although it is uncertain which type of PD patients will benefit most and which stimulation parameters work best. The investigators will assess the effects of SCS on posture and gait using a series of clinical, laboratory, imaging, and wearable measurements.
The participants will receive a percutaneous implantation of a spinal cord stimulator to minimise the possible adverse effects related to the surgery.
The SCS will start one month after surgery. The investigators will use a double-blind cross-over design. The participants will receive three different stimulation parameters, including sham stimulation, in a randomised order. The participants and the assessors will be blinded to the stimulation parameters.
详细描述
The investigators aim to recruit up to 8 people with Parkinson's with significant gait dysfunction which is resistant to medical therapy to this study. All participants will receive implantation of a spinal cord stimulator at T8-10 levels. The procedure will be done percutaneously. The spinal cord stimulation will be commenced 2-4 weeks after surgery to allow time for recovery.
Participants will receive 3 different stimulation parameters in randomised order as outlined below:
- Burst stimulation
- High frequency stimulation
- Sham stimulation Each parameter will last for up to 6 weeks. Both the patients and the researchers assessing the patients will be blinded to the settings parameters. At baseline and at the end of each stimulation settings, the participants will undergo a series of assessments (see secondary outcomes). At the end of the cross-over blinded period, the participants will be unblinded and offered to continue with the parameter that offered most symptomatic relief. The participants will then continue in this setting in an open label phase for another 10 weeks before their final assessment at 7 months.
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
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 45 ≤ X ≤ 85
- •PD diagnosis based on UK Parkinson's disease society brain bank criteria
- •Significant gait dysfunction, particularly freezing of gait, which is resistant to optimal medical therapy
- •Hoen and Yahr stage: 2-4 (in ON state)
- •Stable dopaminergic treatment for at least two weeks before enrolment.
- •Can provide informed consent
排除标准
- •Atypical or secondary parkinsonism e.g. vascular, drug-induced
- •Major focal brain disorders (including malignancy or stroke)
- •Recent (within 3 months)/current use of acetylcholinesterase inhibitors or antidopaminergic drugs
- •Concomitant treatment with deep brain stimulation
- •Neurological, vestibular, visual or orthopaedic diagnosis significantly interfering with gait
- •Pregnant women or planning to become pregnant
- •Significant chronic back pain
- •Spinal anatomical abnormalities precluding SCS surgery
- •Major cognitive or psychiatric illness
- •Concomitant or recent (less than 4 months) enrolment in an interventional research trial.
结局指标
主要结局
Number of Participants with Incidence of Serious Adverse Events
时间窗: Day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
Safety of a 28-week SCS Intervention will be assessed by measuring the number of participants with serious adverse events
Number of Participants with Incidence of Treatment-Emergent Adverse Events
时间窗: Day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
Safety of a 28-week SCS Intervention will be assessed by measuring the number of participants with adverse events that are related to treatment
Number of Participants that complete the study
时间窗: Day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery
Safety of a 28-week SCS Intervention will be assessed by measuring the number of participants that complete the study
次要结局
- Change in Hoehn and Yahr Scoring Scale(Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery)
- Changes in 10 meter walk test (10MW) performance (sec)(Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery)
- 1. Mean change from baseline to week 28 in participant scores on the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part 3 motor subsection in the "OFF" and "ON" medication state(Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery)
- Change in New Freezing of Gait Questionnaire(Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery)
- Changes in Timed Up and Go (TUG) test Performance (sec)(Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery)
- Changes in 360° turning performance (sec)(Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery)
- Changes in Non-motor Symptoms of PD(Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery)
- Mean change in objective, unsupervised quantification of participant motor impairment, using motion sensors(Baseline, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery)
- Change in balance: objective measure of sway velocity on a force platform (metre/sec)(Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery)
- Changes in Quality of Life Measured by a 39-item Parkinson's Disease Questionnaire (PDQ-39)(Baseline, day 1 post-surgery, week 6 post-surgery, week 12 post-surgery, week 18 post-surgery, week 28 post-surgery)