Unilateral Pallidal vs Unilateral Subthalamic Nucleus Deep Brain Stimulation in the Same Patient With Parkinson Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Difference in Timed Up-and-Go (TUG) task scores between treatment conditions in the on- and off- medication states
研究概览
简要总结
The subthalamic nucleus (STN) and globus pallidus interna (GPi) are two main targets in the deep brain stimulation (DBS) treatment for Parkinson's disease (PD). Large randomized controlled trials, in which patients of comparable clinical and demographics were randomized to either GPi DBS or STN DBS, have demonstrated equal effects of both targets in motor symptom improvement, the superiority of STN DBS in the medication reduction and the potential advantage of GPi DBS for cognitive, psychiatric and axial aspects. Unfortunately, in such a highly heterogeneous disease of PD, many of these randomized controlled trials didn't include sufficient subjects and thereby yielded inconsistent results. Moreover, most studies are investigating the difference between GPi and STN in different patients.
In order to address the problem, an intra-patient comparison will be made by investigating the acute turning-on effects of unilateral STN stimulation versus unilateral GPi stimulation on axial symptoms, cognition and also cardinal symptoms within each individual patient who received the treatment of combined unilateral STN and contralateral GPi DBS. Axial symptoms including gait, balance and posture, motor symptoms and cognition are comprehensively assessed under two treatment conditions.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Throughout the study, all participants, independent raters/evaluators and statisticians will be blind to the treatment conditions and parameter configurations. Independent raters who are blind to the conditions will be responsible for the conduct of all the assessments. Participants are blind to the treatment conditions. Movement disorders clinician responsible for programming are blind to the study protocol. They are simply told to adjust parameter to optimize therapeutic effects.
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with idiopathic Parkinson's disease
- •Aged between 55 and 75 years, both male and female
- •Patients who have undergone combined unilateral STN and contralateral GPi DBS for more than 6 months
- •A Hoehn-Yahr (H-Y) stage of less than 4 in the off-medication state
- •A left-extremity to right-extremity ratio of less than 0.15 on the Unified Parkinson's Disease Rating Scale part Ⅲ (UPDRS-Ⅲ) in the both off-medication and on-medication states
排除标准
- •History of serious psychosis
- •History of intractable epilepsy (i.e., seizures)
- •Diagnosed by the investigators that patients with severe cardiac, liver and kidney diseases, or other serious health conditions
- •Dementia (A Mini-Mental State Examination (MMSE) score of < 24), inability to comprehend the experimental protocol or voluntarily provide informed consent
- •Lack of cooperation
- •Additional reasons for exclusion at the discretion of the clinical investigator
- •Poorly controlled depression or anxiety
- •Past history of suicidal attempt
结局指标
主要结局
Difference in Timed Up-and-Go (TUG) task scores between treatment conditions in the on- and off- medication states
时间窗: 6 months
Timed Up-and-Go task is a well-defined objective gait measurement. The task requires an individual to stand up, walk 5 m, turn, walk back, and sit down. The time taken to complete the test is strongly correlated with the level of functional mobility. This test will be videotaped and scored by two blinded neurologists.
次要结局
- Differences in total Unified Parkinson's Disease Rating Scale Part Ⅲ (UPDRS Ⅲ) scores between two treatment conditions in the on- and off- medication states(6 months)
- Differences in Burg Balance Scale (BBS) scores between two treatment conditions in the on- and off- medication states.(6 months)
- Differences in postural angles between two treatment conditions in the on- and off- medication states.(6 months)
- Differences in Water Swallow Test (WST) scores between treatment conditions in the on- and off- medication states.(6 months)
- Differences in Swallowing Disturbance Questionnaire (SDQ) scores between treatment conditions in the on- and off- medication states.(6 months)
- Differences in voice parameters between treatment conditions in the on- and off- medication states.(6 months)
- Differences in Voice Handicap Index (VHI) between treatment conditions in the on- and off- medication states.(6 months)