A Prospective, Multi-center, Post-market Clinical Follow-up Study of the directSTIM Deep Brain Stimulation (DBS) System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 12
- 主要终点
- Materiovigilance
研究概览
简要总结
The purpose of this study is to obtain clinical outcome data on safety and effectiveness of the directSTIM DBS system when used on-label, according to the instructions for use.
All participants will undergo bilateral implant in the subthalamic nucleus (STN) and data collected in common practice will be recorded during six months post-implant and analyzed.
详细描述
directSTIM DBS Therapy for Movement Disorders is indicated for patients with disabling tremor or symptoms of Parkinson's disease.
Subjects selected to participate in the study will be Parkinson's Disease (PD) patients who are eligible for bilateral DBS for STN therapy and meet the inclusion criteria and none of the exclusion criteria.
Primary safety and effectiveness endpoints data will be collected through 6 months of follow-up. The values used for comparison are derived from a review of literature spanning from 2001 to 2019.
After completing the 6 month follow-up, subject will exit the study, and continue to be followed by their physician per usual care.
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
- •Established diagnosis of idiopathic Parkinson's Disease for 4 years or more according to the United Kingdom Parkinson's disease Brain Bank criteria, with disabling motor complications despite optimal medical treatment.
- •Patient is eligible for bilateral DBS for STN therapy according to center's routine criteria and according to the directSTIM DBS system Indications for Use statement.
- •Patient who is willing to provide a written informed consent.
- •Patient complies with the study follow-up, in particular the follow-up visits, and other study requirements.
排除标准
- •Patient is not eligible for DBS per center criteria.
- •Patient has a cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to complete study assessments, such as:
- •Active major psychiatric disorder.
- •Dementia (MoCa Dementia Rating Scale score <26 or otherwise not capable of discernment).
- •Presence of an electrical or electromagnetic implant (e.g. cochlear implant, pacemaker).
- •Previous surgery for the treatment of Parkinson's disease.
- •Previous brain ablation procedure.
- •Epilepsy.
- •Coagulopathies.
- •Abuse of drugs or alcohol.
- •Patient is participating in another clinical study that would confound data analysis.
- •Patient is pregnant or nursing. As for other DBS systems, the effects of the device on an unborn child are not established.
结局指标
主要结局
Materiovigilance
时间窗: 6 months
Summary statistics on the occurrence of the following categories of adverse events (AEs): * Device-related AEs * Procedure-related AEs * Stimulation-related AEs
Change in UPDRS III score without medication
时间窗: 6 months compared to baseline
Part 3 of the Unified Parkinson's Disease Rating Scale (UPDRS III), is a series of questions evaluated by the clinician in presence of the patient, focusing on motor symptoms of PD. Score is expressed on a scale of 0 to 108. This score is evaluated at baseline and 6 months post-implant without any anti-Parkinson medication taken. A decrease at 6 months compared to baseline indicates an improvement. The average difference of scores between the two time points is calculated for the whole study subject population. This value is to be compared to the results of a meta-analysis performed on data extracted during a literature search.
次要结局
- Therapeutic Window (TW)(3 months)
- UPDRS(6 months)