Deep Brain Stimulation of Asymmetric Targets Versus Bilateral Subthalamic Nucleus (STN) for Parkinson's Disease With Postural Instability/Gait Difficulty: a Prospective, Randomized, Double-blinded Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from Baseline in the Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 12 months
研究概览
简要总结
The purpose of this study is to compare the effectiveness of the deep brain stimulation of asymmetric targets [subthalamic nucleus (STN) in the right hemisphere while globus pallidus interna (GPi) in the left] versus the bilateral STN for the treatment of Parkinson's disease (PD) with postural instability/gait difficulty (PIGD) in a randomized, double-blinded manner.
详细描述
This is a double-blinded, randomized, controlled trial aiming at comparing the efficacy of asymmetric targets and bilateral STN DBS in treating PD with PIGD.
After being informed about the study and potential risks, enrolled patients giving written informed consent will be screened to determine eligibility for study entry. Patients who meet the eligibility requirements will be randomized into two groups in a 1:1 ratio using a minimization randomization method in a double-blinded manner, and later undergo bilateral DBS surgery. One group of patients will receive stimulation of left GPi and right STN, while the other will receive STN stimulation bilaterally. The follow-up period will be one year, with corresponding clinical assessments completed at six months and one year postoperatively.
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)
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
- 否
入选标准
- •diagnosis of idiopathic Parkinson's disease
- •postural instability/gait difficulty (PIGD) phenotypes in the on-medication condition
排除标准
- •Atypical parkinsonism
- •History of stroke, encephalitis, neuroleptic uses, MRI scan with evidence of significant brain atrophy, lacunar infracts, or other conditions that might interfere with intracranial surgery
- •Presence of cognitive, or psychiatric or other co-morbidities (e.g., dementia, epilepsy, cranial traumatism, brain tumor, schizophrenia, severe depression or bipolar disorder, personality disorder, etc.) that might interfere with the patient's ability to complete the evaluations or to provide informed consent
- •Presence of anatomical abnormalities in the target region
- •Clinically significant medical history that would increase pre-/post-operative complications
- •Other conditions considered by the investigators that might interfere with the surgery procedure, the follow-ups, and the interpretation of the data
结局指标
主要结局
Change from Baseline in the Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 12 months
时间窗: Baseline and 12 months
In the off-medication condition, scores could range from 0 (no movement symptoms) to 72 (severe movement symptoms).
Change from Baseline in the number of freezing episodes on the Timed Up and Go test at 12 months
时间窗: Baseline and 12 months
in the off-medication condition
Change from Baseline in balance ability on the Burg Balance Scale (BBS) at 12 months
时间窗: Baseline and 12 months
In the off-medication condition, the scores could range from 0 (severe balance problem) to 56 (no balance problem).
次要结局
- Change from Baseline in freezing of gait on the New Freezing of Gait Questionnaire (NFOG-Q) at 12 months(Baseline and 12 months)
- Change from Baseline in the number of freezing episodes on the Timed Up and Go test at 6 months(Baseline and 6 months)
- Change from Baseline in completion time on the Timed Up and Go test at 6 months(Baseline and 6 months)
- Change from Baseline in the number of steps on the Timed Up and Go test at 12 months(Baseline and 12 months)
- Change from Baseline in the Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 6 months(Baseline and 6 months)
- Change from Baseline in balance confidence on the Activities-Specific Balance Confidence Scale (ABC) at 12 months(Baseline and 12 months)
- Change from Baseline in completion time on the Timed Up and Go test at 12 months(Baseline and 12 months)
- Change from Baseline in the number of steps on the Timed Up and Go test at 6 months(Baseline and 6 months)
- Change from Baseline in balance confidence on the Activities-Specific Balance Confidence Scale (ABC) at 6 months(Baseline and 6 months)
- Change from Baseline in freezing of gait on the New Freezing of Gait Questionnaire (NFOG-Q) at 6 months(Baseline and 6 months)
- Change from Baseline in gait impairment on the Gait and Fall Questionnaire (GFQ) at 12 months(Baseline and 12 months)
- Change from Baseline in medication usage on the Levodopa Equivalent Daily Dose at 6 months(Baseline and 6 months)
- Adverse events(up to 12 months after surgery)
- Change from Baseline in dysphagia severity on the Swallowing Disturbance Questionnaire (SDQ) at 12 months(Baseline and 12 months)
- Change from Baseline in dysphagia severity on the Swallowing Disturbance Questionnaire (SDQ) at 6 months(Baseline and 6 months)
- Change from Baseline in gait impairment on the Gait and Fall Questionnaire (GFQ) at 6 months(Baseline and 6 months)
- Change from Baseline in medication usage on the Levodopa Equivalent Daily Dose at 12 months(Baseline and 12 months)
- Change from Baseline in maximal phonatory time at 12 months(Baseline and 12 months)
- Change from Baseline in dysphonia severity index (DSI) at 6 months(Baseline and 6 months)
- Change from Baseline in maximal phonatory time at 6 months(Baseline and 6 months)
- Change from Baseline in dysphonia severity index (DSI) at 12 months(Baseline and 12 months)
- Change from Baseline in cognition on the Montreal Cognitive Assessment at 12 months(Baseline and 12 months)
- Change from Baseline in cognition on the Montreal Cognitive Assessment at 6 months(Baseline and 6 months)
- Change from Baseline in balance ability on the Burg Balance Scale (BBS) at 6 months(Baseline and 6 months)