Asleep MRI-guided and CT-verified Versus Awake Microelectrode Recording Guided Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease: A Comparative Effectiveness Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 158
- 主要终点
- Unified Parkinson's Disease Rating Scale part III
研究概览
简要总结
Rationale: Bilateral deep brain stimulation (DBS) of the subthalamic nucleus (STN) is a well-accepted treatment for Parkinson's disease (PD). Traditionally, the procedure is performed awake and under local anaesthesia to facilitate intraoperative monitoring via microelectrode recording and test stimulation for exact electrode positioning. Advances in MR imaging allow for clear visualization of the STN and therefore direct targeting. Retrospective series suggest that MRI-guided and image (CT or MRI)-verified STN-DBS under general anaesthesia yields a similar motor outcome and quality of life (QoL) as awake and microelectrode recording-guided surgery with intra-operative clinical testing. MRI-guided and image (CT or MRI)- verified approach potentially has advantages in terms of patient experience and cost-effectiveness. The study proposed here is the first in the world to directly compare both methods.
Objective: To compare bilateral MRI-guided and CT-verified STN-DBS under general anaesthesia to awake microelectrode-guided bilateral STN-DBS with intra-operative clinical testing in terms of motor improvement.
Study design: A multicentre comparative effectiveness trial with a non-inferiority design. Study population: 158 PD people eligible for bilateral STN-DBS (79 in each arm).
Intervention: This study compares two modalities of standard treatment. One arm receives awake microelectrode recording guided bilateral STN-DBS under local anaesthesia with intraoperative clinical testing. The other arm receives MRI-guided and CT-verified bilateral STN-DBS under general anaesthesia.
Main study parameters/endpoints: The primary outcome is the change from baseline to one year in Unified Parkinson's Disease Rating Scale part III (UPDRS III) scores (OFF Medication) versus the postoperative scores (OFF medication and ON stimulation). Secondary objectives include patient experience, quality of life, adverse effects and complications, neuropsychological examination, non-motor symptoms (including psychiatric evaluation), reduction in anti-parkinsonian medication, activities of daily living (ADL) functioning and cost- effectiveness.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30-75 years of age
- •Idiopathic Parkinson's disease (according to the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease)
- •Disease duration ≥ 4 years
- •Hoehn & Yahr ≤ 3 (in best ON-medication condition)
- •Despite optimal pharmacological treatment, at least one of the following symptoms:
- •Disturbing response fluctuation
- •Dyskinesia
- •Painful dystonia
- •Drug-resistant tremor
- •≥30% improvement of Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III score in a levodopa challenge test, except for tremor dominant PD. This is conform daily clinical practice in all participating centres.
- •Written informed consent
排除标准
- •Dementia (Montreal Cognitive Assessment ≤ 25)
- •Previous neurosurgical procedures for PD
- •Structural lesions on brain MRI
- •Contra-indications for DBS surgery
- •Contra-indications for MRI
- •Current depression or history recurrent severe depression
- •History of psychosis
- •Need for nursing care
- •Life expectancy < 2 years
结局指标
主要结局
Unified Parkinson's Disease Rating Scale part III
时间窗: 12 months
change from baseline to 1 year in Unified Parkinson's Disease Rating Scale part III (min 0, max. 132; higher score means worse outcome)
次要结局
- Patient experience and satisfaction(during hospitalization and follow up visits at approximately 2 weeks after surgery, 6 and 12 months)
- Non-Motor Symptoms(12 months)
- Neuropsychiatric symptoms(12 months)
- Complications and (serious) adverse effects(12 months)
- Non-motor aspects of experiences of daily living(12 months)
- health-related quality of life(12 months)
- Impulsivity(12 months)
- Cognitive impairment(12 months)
- Patient's sleepiness(12 months)
- Cost effectiveness(during hospitalization (range 3-5 days, median 4 days))
- reduction in anti-parkinsonian medication(12 months)
- Motor aspects of experiences of daily living measured(12 months)
- Motor complications after DBS surgery(12 months)
- Depressive symptoms(12 months)
- Anxiety(12 months)
- Autonomic symptoms(12 months)