Subscalp Placement Of The LINQII Device: A First-in-human Device Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Total number of recordings obtained
研究概览
简要总结
The purpose of this to evaluate the capability of the FDA approved Medtronic LINQ II device (implantable cardiac monitoring device) to record EEG signals when placed temporarily in the subscalp space in patients undergoing cranial neurosurgery. No disease-directed therapeutic efficacy endpoints will be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18-80 years old.
- •Undergoing (or expected to undergo) intracranial EEG electrode or deep brain stimulator placement surgery as part of clinical standard of care.
排除标准
- •Patients deemed by the neurosurgery team to be at elevated risk of infection or hemorrhage because of the study procedure.
- •Individuals who cannot provide informed consent, do not have an available legally authorized representative, or are part of vulnerable or protected populations.
- •Pregnant or breast-feeding female participants.
- •Women of childbearing potential will be screened prior to surgery following standard of care procedures.
研究组 & 干预措施
Deep Brain Stimulation Patients
Patients undergoing a deep brain stimulation procedure will have the LINQII device implanted temporarily
干预措施: Medtronic LINQII (Device)
Stereo-electrode (SEEG) Patients
Patients undergoing a stereo-electrode (SEEG) procedure will have the LINQII device implanted temporarily
干预措施: Medtronic LINQII (Device)
结局指标
主要结局
Total number of recordings obtained
时间窗: Baseline
Number of subjects to have brain signal recordings obtained by the LINQII device.
次要结局
未报告次要终点
研究者
Jonathon J. Parker
Principal Investigator
Mayo Clinic