Asymmetric Deep Brain Stimulation for Parkinson's Disease: A Multicenter, Prospective, Single Arm, Open Label Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale - Part III (MDS UPDRS-III)
研究概览
简要总结
Deep brain stimulation (DBS) is an efficacious neurosurgical treatment for moderate-to-late stage Parkinson's disease (PD). The subthalamic nucleus (STN) and globus pallidus interna (GPi) are two targets extensively studied and used worldwide in treating PD. Although the conventional SYMMETRIC bilateral STN and GPi DBS are shown to be effective in controlling motor symptoms such as bradykinesia, tremor, and dyskinesia, each target has its pros and cons in terms of axial symptom control, medication reduction, cognitive decline, and programming. Therefore, we speculate that an ASYMMETRIC bilateral implantation of DBS leads (i.e., combined unilateral STN and contralateral GPi DBS) may be able to bring the greatest clinical benefits to PD patients by taking advantage of both bilateral STN and GPi DBS at the same time. The preliminary retrospective study containing eight PD patients undergoing asymmetric implantation of DBS demonstrated the safety and efficacy of this treatment strategy during short-term follow-up. This multicenter, single arm, open label study aims to prospectively investigate during the long-term follow-up the safety and efficacy of asymmetric DBS for PD in terms of motor and nonmotor symptoms, medication reduction, cognitive decline, and quality of life.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with idiopathic Parkinson's disease based on the MDS clinical diagnostic criteria for Parkinson's disease
- •Aged more than 18 years
- •Levodopa challenge test indicating a preoperative levodopa responsiveness over 24% based on MDS UPDRS-III
- •the modified Hoehn-Yahr Scale between 2 and 4 under on-medication condition
- •Compliance with written informed consent
排除标准
- •Atypical parkinsonian syndrome
- •History of stroke, encephalitis, neuroleptic uses, MRI scan with evidence of significant brain atrophy, lacunar infracts, or other conditions that might interfere with the 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 or that increases 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
Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale - Part III (MDS UPDRS-III)
时间窗: Followed for minimum of 7 years
Score ranges from 0 to 132, higher scores mean a worse outcome.
次要结局
- Beck Depression Inventory, BDI(Followed for minimum of 7 years)
- Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale - Part I, II, IV(Followed for minimum of 7 years)
- Time-Up-Go (TUG) task(Followed for minimum of 7 years)
- Gait and Falls Questionnaire, GFQ(Followed for minimum of 7 years)
- Berg Balance Scale, BBS(Followed for minimum of 7 years)
- Montreal Cognitive Assessment (MoCA)(Followed for minimum of 7 years)
- Beck Anxiety Inventory, BAI(Followed for minimum of 7 years)
- Apathy Estimation Scale, AES(Followed for minimum of 7 years)
- Epworth Sleepiness Scale, ESS(Followed for minimum of 7 years)
- Scales for Outcomes in PArkinson's disease - Autonomic, SCOPA-AUT(Followed for minimum of 7 years)
- Levodopa Equivalent Daily Dose, LEDD(Followed for minimum of 7 years)
- Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Current Full, QUIP-CF(Followed for minimum of 7 years)
- Non-Motor Symptoms Scale, NMSS(Followed for minimum of 7 years)
- 8-item Parkinson's Disease Questionnaire (PDQ-8)(Followed for minimum of 7 years)
- 5-Level EuroQol Five Dimensions Questionnaire, EQ-5D-5L(Followed for minimum of 7 years)
- Adverse Events, Severe Adverse Events(Followed for minimum of 7 years)
研究者
Bomin Sun
Director of Center for Functional Neurosurgery, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Ruijin Hospital