Subthalamic Nucleus Versus Globus Pallidal Internus Deep Brain Stimulation for Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 86
- 试验地点
- 16
- 主要终点
- Unified Parkinson's Disease Rating Scale Part III (UPDRS III) score
研究概览
简要总结
The primary objective of this prospective, multicenter, double-blind, randomized, crossover clinical trial is to evaluate whether Subthalamic Nucleus-Deep Brain Stimulation (STN-DBS) is more effective than Globus Pallidus Internus-Deep Brain Stimulation (GPi-DBS) in improving motor symptoms of patients with Parkinson's disease at 90 days post-treatment.
详细描述
The primary objective of this prospective, multicenter, double-blind, randomized crossover controlled clinical trial is to evaluate whether STN-DBS provides superior efficacy over GPi-DBS in improving motor symptoms of Parkinson's disease patients at 90 days post-treatment.
Randomization of this study is generated by a centralized Contract Research Organization (CRO). At the second follow-up visit, patients will be assigned according to the randomization code list in the system, with each patient first receiving either STN-DBS or GPi-DBS. The randomization ratio between the two groups is 1:1. At the third follow-up visit, each group will then receive stimulation at the other target.
Assessments of motor function, cognitive level, anxiety and depression status, and quality of life will be conducted preoperatively. The device will be activated 30 days postoperatively. Target adjustments, along with assessments of motor function, cognitive level, anxiety and depression status, quality of life, and adverse events, will be performed at 120, 210, and 300 days postoperatively.
The grouping information will only be known to the operating surgeons and programming physicians, while other investigators, assessing physicians, and patients will remain blinded. This study will be completed within 24 months, enrolling 86 patients from 7 centers in China, with 43 patients in each group. The Data Safety Monitoring Board (DSMB) will conduct regular monitoring to ensure the safe conduct of the study.
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, Investigator)
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at the time of enrollment: 22-75 years.
- •Diagnosis of bilateral idiopathic PD with the presence of at least 2 of the following: resting tremor, rigidity, or bradykinesia
- •Duration of idiopathic PD: ≥ 5 years.
- •Severity of PD in the meds off condition: Hoehn-Yahr stages 2.5~ 4.
- •Despite optimal medication treatment, there are still persistent symptoms or drug side effects of disabling Parkinson's
- •Must have tried a form of carbidopa/levodopa and/or one of the dopamine agonists as part of medication therapy.
- •Anti-parkinsonian medications must improve PD symptoms by ≥33%, as measured by UPDRS-III score.
- •UPDRS-III score of ≥ 30 in the meds off condition.
- •The MMSE assessment was higher than the demarcation score of the corresponding educational level, and the cognitive function was normal.
- •HAMD score≤
- •No change in antidepressant medications utilized for treatment of depression for at least 8 weeks prior to informed consent.
- •Stable on anti-parkinsonian medication for 28 days prior to informed consent.
- •Could tolerate bilateral STN DBS and bilateral GPi DBS.
- •Be willing and able to comply with all visits and study related procedures (e.g., using the remote control, charging system and completing the PD Diary
- •Able to understand the study requirements and the treatment procedures and provides written informed consent before any studyspecific tests or procedures are performed.
排除标准
- •Any intracranial abnormalities or medical conditions that Lead to the prohibition of DBS surgery.
- •Have any significant psychiatric condition likely to compromise the subject's ability to comply with requirements of the study protocol (e.g. bipolar, schizophrenia, mood disorder with psychotic features, cluster B personality disorders).
- •HAMD score>
- •Any current drug or alcohol abuse, per DSM-IV criteria
- •Any history of recurrent or unprovoked seizures.
- •Any history of hemorrhagic stroke.
- •Any previous treatment for movement disorders involving intracranial surgery or device implantation.
- •Any other active implanted devices including neurostimulators (e.g., cochlear implant, pacemaker) and /or drug delivery pumps, whether turned on or off. Passive implants (e.g., knee prostheses) would be allowed provided that they do not interfere with the functioning of the DBS system
- •Any previous thalamotomy, pallidotomy or subjects who have undergone a DBS procedure.
- •Any previously implanted Vagus Nerve Stimulation (VNS) patients.
- •Any previous brain surgery that would interfere with the placement of the leads or the functioning of the device.
- •A condition requiring or likely to require the use of Magnetic Resonance Imaging (MRI), diathermy or electroconvulsive therapy (ECT)
- •Likely to require the use of monopolar cau Likely to require the use of monopolar cautery, radiofrequency (RF) procedures, external defibrillation, lithotripsy, radiation therapy or transcranial stimulation.tery, radiofrequency (RF) procedures, external defibrillation, lithotripsy, radiation therapy or transcranial stimulation.
- •Currently on any anticoagulant medications that cannot be discontinued during perioperative period.
- •Currently exhibiting secondary Parkinsonism due to prescribed medications.
- •Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
- •Any terminal illness with life expectancy of < 1 year.
- •Any unresolved infection, a coagulopathy or significant cardiac or other medical risk factor for surgery
- •Current or future risk of being immunocompromised that might significantly increase risk of infection.
- •Participation in any other clinical trial (e.g. drug, device, or biologics) concurrently or within the preceding 30 days. Participation in any other study will be allowed per investigator/sponsor discretion only.
- •A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.
- •Preoperative DBS plan failed to implant STN and GPi. nuclei.(Usually limited by individual anatomical differences)
- •Preoperative CT scan of the head revealed calcification of the GPI.
结局指标
主要结局
Unified Parkinson's Disease Rating Scale Part III (UPDRS III) score
时间窗: Before surgery and 90 days (±7 days) after surgery
The differences in UPDRS III scores obtained under the stimulation state at 90 days (±7 days) after surgery, compared with the preoperative scores, in patients with Parkinson's disease who received Subthalamic Nucleus-Deep Brain Stimulation (STN-DBS) or Globus Pallidus Internus-Deep Brain Stimulation (GPi-DBS) treatment. Doctors conducted double-blind evaluations based on this scoring scale. The Unified Parkinson's Disease Rating Scale Part III (UPDRS III) has a scoring range of 0 to 108 points, with higher scores indicating more severe motor symptoms in patients with Parkinson's disease.
Unified Parkinson's Disease Rating Scale Part III (UPDRS III) score
时间窗: Before surgery and 90 days (±7 days) after surgery
The differences in UPDRS III scores obtained under the stimulation state at 90 days (±7 days) after surgery, compared with the preoperative scores, in patients with Parkinson's disease who received Subthalamic Nucleus-Deep Brain Stimulation (STN-DBS) or Globus Pallidus Internus-Deep Brain Stimulation (GPi-DBS) treatment. Doctors conducted double-blind evaluations based on this scoring scale. The Unified Parkinson's Disease Rating Scale Part III (UPDRS III) has a scoring range of 0 to 108 points, with higher scores indicating more severe motor symptoms in patients with Parkinson's disease.
次要结局
- Programming parameters(90 days (±7 days) after surgery)
- Parkinson's Disease Questionnaire-39 (PDQ-39) score(Before surgery and 90 days (±7 days) after surgery)
- Freezing of Gait Questionnaire (FOG-Q) score(Before surgery and 90 days (±7 days) after surgery)
- Berg Balance Scale (BBS) score(Before surgery and 90 days (±7 days) after surgery)
- Unified Dyskinesia Rating Scale (UDysRS) score(Before surgery and 90 days (±7 days) after surgery)
- Mini-Mental State Examination (MMSE) score(Before surgery and 90 days (±7 days) after surgery)
- Montreal Cognitive Assessment (MoCA) score(Before surgery and 90 days (±7 days) after surgery)
- Hamilton Anxiety Rating Scale (HAMA) score(Before surgery and 90 days (±7 days) after surgery)
- Hamilton Rating Scale for Depression (HRSD) score(Before surgery and 90 days (±7 days) after surgery)
- Differences in programming parameters and medication under combined stimulation(Baseline and 90 days (±7 days) after surgery)
- Patient preference for stimulation targets(90 days (±7 days) after surgery)
- Freezing of Gait Questionnaire (FOG-Q) score(Before surgery and 90 days (±7 days) after surgery)
- Berg Balance Scale (BBS) score(Before surgery and 90 days (±7 days) after surgery)
- Unified Dyskinesia Rating Scale (UDysRS) score(Before surgery and 90 days (±7 days) after surgery)
- Mini-Mental State Examination (MMSE) score(Before surgery and 90 days (±7 days) after surgery)
- Montreal Cognitive Assessment (MoCA) score(Before surgery and 90 days (±7 days) after surgery)
- Hamilton Anxiety Rating Scale (HAMA) score(Before surgery and 90 days (±7 days) after surgery)
- Hamilton Rating Scale for Depression (HRSD) score(Before surgery and 90 days (±7 days) after surgery)
- Parkinson's Disease Questionnaire-39 (PDQ-39) score(Before surgery and 90 days (±7 days) after surgery)
- Programming parameters(90 days (±7 days) after surgery)
- Differences in programming parameters and medication under combined stimulation(Baseline and 90 days (±7 days) after surgery)
- Patient preference for stimulation targets(90 days (±7 days) after surgery)
研究者
Zhang Jianguo
Deputy Director of the Neurosurgery Center,Director of the Functional Neurosurgery Ward,Director of the Neural Function Laboratory
Beijing Municipal Administration of Hospitals