Safety and Effectiveness of Closed-loop DBS in Parkinson's Disease: A Long-term Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Movement disorders evaluation
研究概览
简要总结
Closed-loop DBS is an emerging neuromodulation pattern in Parkinson's disease with dyanmic adjustment of stimulation parameters to patients' disease fluctuations and state of activity. The purpose of this study is to verify the long-term safety and effectiveness of closed-loop DBS. Through comparing with open-loop DBS, the study also determine whether closed-loop DBS is more effective than conventional open-loop DBS on PD treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary Parkinson's disease: Diagnosis of primary Parkinson's disease should meet the diagnostic criteria outlined in the "Diagnosis Standards for Parkinson's Disease in China" published in 2016 or the diagnostic criteria for primary Parkinson's disease by the International Parkinson and Movement Disorder Society (MDS) published in
- •Good response to levodopa combination therapy.
- •Significant reduction in drug efficacy or significant impact on the patient's quality of life due to prominent motor complications.
- •Intolerable adverse reactions to medication affecting its efficacy.
- •Presence of uncontrollable tremors despite medication.
排除标准
- •Patients who have undergone pallidotomy or other brain surgeries.
- •Patients with secondary Parkinson syndromes or Parkinson plus syndromes.
- •Patients with concurrent central nervous system and peripheral nervous system diseases.
- •Patients with severe systemic diseases, unstable vital signs, or those who cannot tolerate clinical assessments.
- •Patients with severe psychiatric disorders.
- •Patients who are unable to provide informed consent due to cognitive or communication impairments or those who refuse to sign the informed consent form.
结局指标
主要结局
Movement disorders evaluation
时间窗: 1-3 days
Using MDS-UPDRS III rating scale （0-132, the higher score means a worse outcome） and Rush dyskinesia rating scale （0-12, the higher score means a worse outcome） combined with IMU to evaluate the motor function improvement under both closed-loop DBS and open-loop DBS condition
Sleep Structure Evaluation
时间窗: 1-3 nights
Using polysomnography evaluation （sleep efficiency，N1/N2/N3/REM/Wake after sleep onset duration and percentage，arousal index） and subjuective sleep quality rating scale to evaluate the sleep improvement under both closed-loop DBS and open-loop DBS condition
Diary Outcomes in Parkinson's Disease
时间窗: 1-3days
Using SCOPA-DC （0-87, the higher score means a worse outcome） to evaluate the diary outcomes under both closed-loop DBS and open-loop DBS condition
次要结局
- Safety (Stimulation-related AEs) and Subjective Satisfactory(1-3days)
- Total Electrical Energy Delivered to patients(1-3days)