Remote Programming for Deep Brain Stimulation in Parkinson's Disease: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Cost-effectiveness
研究概览
简要总结
This study aims to conduct a randomized controlled study to compare the efficacy of remote programming (RP) on the improvement of motor function after DBS surgery in PD patients with standard programming (SP).
详细描述
This is a randomized controlled trial aiming at comparing the efficacy of RP and SP in post-operative management of PD patients with DBS. Enrolled patients will be randomly assigned to the RP or SP groups before surgery. After recording baseline data, regular programming sessions will be conducted through RP or SP. Patients will be followed up in 6 months after implantation, with the main goal of the differences in motor symptom improvement between the two groups and the secondary goal of the difference in safety and economic benefits between both methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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
- 是
入选标准
- •Adult primary Parkinson's disease patients who meet the diagnostic criteria for Parkinson's disease in China (2016 edition), aged 18-75 years
- •Comply with the surgical indications of the "Expert Consensus on Deep Brain Stimulation Therapy for Parkinson's Disease in China (Second Edition)" and complete bilateral STN-DBS surgery
- •Accurate lead position verified by postoperative CT examination
- •The implanted DBS device has remote programming function
- •Having an internet connection at home or in the area that will receive remote postoperative management, and being able to participate in remote symptom assessment and remote programming
- •Able to communicate fluently, and after education, I and my caregivers are proficient in using the patient client of the remote program control system
- •Understand potential risks/benefits, agree to participate in the study, study procedures, agree to complete the study follow-up, and comply with the requirements of the study protocol.
排除标准
- •The preoperative concise mental state examination (MMSE) score of DBS indicates moderate or above cognitive impairment
- •Severe complications after DBS surgery, such as stroke, encephalitis, wound infection, etc.
- •Lack of cooperation, or inability to understand the experimental plan or provide informed consent for any reason
- •Unable to provide stable network signal or unable to provide 4 × 1.5 m space for motion evaluation
- •Other researchers believe that factors may not be suitable for research.
研究组 & 干预措施
the Remote Programming (RP) group
After implantation of DBS and train for RP in hospital, regularly receive RP instead of in-visit SP for parameter adjustment in 1, 3, 6 month after surgery
干预措施: remote programming (Device)
the Standard Programming (SP) group
After implantation of DBS, regularly receive SP for parameter adjustment in 1, 3, 6 month after surgery
干预措施: standard programming (Device)
结局指标
主要结局
Cost-effectiveness
时间窗: 6 months after surgery
Quality Adjusted Life Years estimated by the cost and EQ-5D-3L.
The unified Parkinson's disease rating scale (UPDRS) Part III
时间窗: Preoperation and 6 months after surgery
The unified Parkinson's disease rating scale (UPDRS) Part III is made up of motor examinations (18 items). Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). Score range: 0-132, 32 and below is mild, 59 and above is severe.
次要结局
- Parkinson's Disease Questionaire-8 (PDQ-8)(Preoperation and 6 months after surgery.)
- Cost of patients' perspective(6 months after surgery.)
- The unified Parkinson's disease rating scale (UPDRS) Part I, II and IV.(Preoperation and 6 months after surgery.)
- European Quality of Life 5 Dimensions 3 Level Version(Preoperation and 6 months after surgery.)
- Beck Depression Inventory (BDI-II)(Preoperation and 6 months after surgery.)
- Beck Anxiety Inventory (BAI)(Preoperation and 6 months after surgery.)
- Mini-Mental State Examination (MMSE)(Preoperation and 6 months after surgery.)
- The Patient Global Impression of Change (PGIC)(Collected within 2 days (48 hours) after each programming.)
- Telehealth Satisfaction Survey (TeSS)(Collected within 2 days (48 hours) after each programming.)
- Safety: Rate of programming related adverse events(Collected within 2 days (48 hours) after each programming.)