Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 18
- 主要终点
- Primary Safety Endpoint: Rate of programming related adverse events for the Virtual Clinic cohort
研究概览
简要总结
The purpose of the ROAM-DBS study is to compare the time needed to achieve a 1 point improvement Patient's Global Impression of change (PGIC) relative to the subject's status at the end of the ADROIT initial programming visit in subjects who receive programming updates via in-clinic sessions and subjects who additionally have the option of receiving programming updates via Virtual Clinic sessions. The study intends to demonstrate shorter times to achieve benefit in the Virtual Clinic cohort.
详细描述
The ROAM-DBS study is a prospective, multi-center, randomized control, open-label, post-market cohort study intended to gather clinical data on the effect of the NeuroSphere Virtual Clinic feature (remote care) on the time needed to optimize DBS stimulation parameters after implant. The study will enroll up to 100 subjects from up to 15 centers in geographies where Abbott DBS systems with the Virtual Clinic feature are approved, which may include North America, and Europe. Subjects should be participants in the ADROIT study (NCT04071847). Subjects will be followed to a 3 month visit where the primary endpoint will be assessed. Subjects will be further followed for 1 year for final data assessment. Subjects will remain enrolled in ADROIT after the end of the ROAM study, and will complete the ADROIT 6 month and 1 year visits under that protocol. The study is expected to enroll subjects for up to 2 years, and complete all follow-up visits within 3 years.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is a participant in the ADROIT study.
- •Subject is over 21 years old.
- •Subject is able to read and write.
- •Subject is indicated for implant with an Infinity IPG for Parkinson's disease.
- •Subject has not previously been implanted with a DBS system.
- •The treating physician believes Virtual Clinic is appropriate as a component in the treatment regime for this subject.
- •Subject will have access to the Abbott Virtual Clinic system through a participating site.
- •Subject will have internet access on their Patient Controller in a location suitable for a Virtual Clinic session.
- •Subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure.
排除标准
- •Subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study.
- •Subject has anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results.
- •As assessed by the treating physician, lead misplacement would prevent the DBS therapy from providing clinically meaningful benefit.
- •Subject is unable to use the Virtual Clinic feature.
- •Subject will not be able, in the investigator's opinion, to demonstrate or articulate symptoms during a Virtual Clinic visit.
研究组 & 干预措施
In-Clinic Cohort
Subjects who are implanted with Abbott Infinity DBS systems with the Neuosphere Virtual Clinic feature, and receive programming for their DBS system in-clinic only.
干预措施: Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature (Device)
Virtual Clinic Cohort
Subjects who are implanted with Abbott Infinity DBS systems with the Neuosphere Virtual Clinic feature, and receive programming for their DBS system with Virtual Clinic and in-clinic sessions.
干预措施: Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature (virtual clinic and in-clinic sessions) (Device)
结局指标
主要结局
Primary Safety Endpoint: Rate of programming related adverse events for the Virtual Clinic cohort
时间窗: At 3-months after initial programming visit
The rate of programming related adverse events reported up to the Short Term (3 month) follow-up visit for the Virtual Clinic cohort will be summarized using counts and percentages.
Primary Efficacy Endpoint: The time to achieve a 1 point improvement Patient's Global Impression of change (PGIC) relative to the subject's status at the end of the initial programming visit
时间窗: PGIC will be collected within 2 days (48 hours) after completion of each programming visit
The PGI consists of 2 subscales, the first rating the severity of illness (PGIS) and the second evaluating the change in illness relative to a previous status (PGIC). The PGI scale evaluates all aspects of health and assesses if there has been a change in clinical status. The scale consists of two items, one scale rating severity of illness and one rating global improvement. Severity is rated from 1=normal/not at all ill to 7= extremely ill. Global improvement is rated from 1=very much improved to 7=very much worse. The questionnaire takes approximately 5 minutes to complete. The time needed to achieve a 1 point improvement Patient's Global Impression of change (PGIC) relative to the subject's status at the end of the initial programming visit in subjects who receive programming updates via in-clinic sessions and subjects who additionally have the option of receiving programming updates via Virtual Clinic sessions, will be compared.
次要结局
- Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(At 1 Year after initial programming visit)
- Levodopa Equivalent Dose (LED)(At 1 Year after initial programming visit)
- "On Time" (time each day without troublesome symptoms or side effects) (derived from Home Monitoring)(At 3-months after initial programming visit)
- Health care resource utilization: Number of hospitalizations and ER visits(At 1 Year after initial programming visit)
- Time to resolve programming related adverse events(At 1 Year after initial programming visit)
- Patient Global Impression (PGI)(At 1 Year after initial programming visit)
- Clinical Global Impression (CGI)(At 1 Year after initial programming visit)
- Home Monitoring (Tremor)(At 3-months after initial programming visit)
- Home Monitoring (Dyskinesia)(At 3-months after initial programming visit)
- Parkinson's Disease Questionnaire (PDQ-39)(At 1 Year after initial programming visit)
- Patient Global Impression (PGI)(At 3-months after initial programming visit)
- Clinical Global Impression (CGI)(At 3-months after initial programming visit)
- Parkinson's Disease Questionnaire (PDQ-39)(At 3-months after initial programming visit)
- Levodopa Equivalent Dose (LED)(At 3-months after initial programming visit)