Deep Brain Stimulation for Parkinson's Disease: Probabilistic STN Targeting Under General Anaesthesia Without Micro-electrode Recordings (MER) vs Current Targeting Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 14
- 主要终点
- Stimulation efficacy
研究概览
简要总结
Deep brain stimulation (DBS) of the sub-thalamic nucleus (STN) has evolved over the past decades as a mainstream therapy for advanced Parkinson's disease (PD). The classical procedure consists in STN indirect targeting based on stereotactic atlases or statistical coordinates in AC-PC (Anterior Commissure - Posterior Commissure) referential along with target control and correction by micro-electrode recordings (MER) and awake clinical testing. To avoid potential complications and patient discomfort related to current procedure, asleep surgery without this control process has become more and more performed, essentially thanks to the progress of neuroimaging allowing to STN visualization. However, it has been reported a relative inaccuracy between the "radiological" STN delimitated on several types of MRI sequences (T2, T2*, SWI) and the per-operative electrophysiological findings. As a result, there are currently many types of STN-DBS procedures, and the lack of standardization between techniques complicates the interpretation of postoperative results on anatomical, electrophysiological and clinical points of view. Furthermore, to date, it has not been proven that asleep surgery without MER and clinical controls is as effective as the standard procedure in a prospective controlled randomized clinical trial.
Investigators hypothesize that the clinical-based 18 landmarks STN target will be precise enough to allow to perform surgery under general anesthesia without MER correction, and accurate enough to achieve non inferior clinical results compared to what is usually done in each centre.
The main objective is to compare at one year, the % of motor improvement after PARKEO 2-targeting asleep DBS without intraoperative MER versus the targeting procedure using intraoperative MER by the UPRDRS 3 (Unified Parkinson's disease rating scale 3).
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of idiopathic Parkinson's disease at the stage of motor fluctuations despite optimal medical treatment
- •L-DOPA sensitivity defined by motor improvement above 50% on the UPDRS-3 scale after a dose of 150% of the usual early morning treatment
- •Indication for STN-DBS approved by the local multidisciplinary movement disorders committee.
- •Patients between 18 and 70 years of age
- •Patients covered by a health insurance scheme
- •Signed informed consent.
排除标准
- •Significant cognitive decline defined as a score < 22 on the MoCA scale
- •Mood disorders defined by a score > 20 on the Beck Depression Inventory
- •Significant cortical atrophy or leukoencephalopathy visualised by brain MRI
- •Contraindication to anaesthesia and MRI
- •Lack of contraceptive treatment for women with ability to procreate
- •Pregnant or breast-feeding woman
- •Unstoppable anticoagulant or antiaggregant treatment
- •Persons under legal protection (Persons deprived of liberty or incapable of giving consent or under curatorship or tutorship…)
- •Patient with severe psychiatric disorders (on Diagnostic and Statistical Manual of Mental Disorders IV)
- •Inability to follow the patient until the end of study
结局指标
主要结局
Stimulation efficacy
时间窗: 12 months after surgery (M12)
The primary endpoint is the efficacy of the stimulation on motor symptoms assessed by the change in UPDRS-3 scores between OFF and ON stimulation evaluations at one year after surgery without any medical treatment (OFF medication). Unified Parkinson's Disease Rating Scale 3 (UPDRS 3) questionnaire: 0 to 132 points, with the highest score indicating worsening
次要结局
- Stereotactic accuracy(Surgery intervention (Month 0))
- Operative characteristics (1)(Surgery intervention (Month 0))
- Operative characteristics (3)(Surgery intervention (Month 0))
- Improvement of UPDRS3(12 months after surgery (M12))
- Post-operative cognitive(12 months after surgery (M12))
- Cost-effectiveness ratio, expressed in terms of cost per Qaly gained at 1 year(12 months after surgery (M12))
- Quality of life assessment(inclusion (Month-1) and 12 months after surgery (M12))
- Operative characteristics (4)(Surgery intervention (Month 0))
- Distance between active contact location and preoperative target(Surgery intervention (Month 0))
- Operative characteristics (2)(Surgery intervention (Month 0))
- Efficacy of the targeting procedure on motor symptoms (2)(12 months after surgery (M12))
- Total cost of each procedure (PARKEO-2 targeting compared to targeting procedure using intraoperative MER)(Surgery intervention (Month 0))
- Post-operative mood(12 months after surgery (M12))
- Efficacy of the targeting procedure on motor symptoms (1)(12 months after surgery (M12))
- reduction in the levodopa equivalent daily doses (LEDD)(12 months after surgery (M12))
- Intra and post-operative surgical complications(Surgery intervention (Month 0))