A Re-attachable Stereotactic Frame System for Clinical Interventive Neurosurgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Comfort level questionnaire
研究概览
简要总结
This study is designed to demonstrate an in-house developed re-attachable stereotactic system that can markedly reduce the overall deep brain stimulation (DBS) procedure time to greatly facilitate subject access to neurosurgical restorative therapies. Subjects will consist exclusively of individuals who have been approved to undergo deep brain stimulation surgery for the treatment of a neurological disorder at Mayo Clinic - Rochester MN. This study is a quantitative comparative, between-subject study enrolling approximately 10 subjects.
详细描述
Aims:
This study will evaluate a new stereotactic device (D1 stereotactic system) designed to address shortcomings of current stereotactic systems by using a novel surface-mounted stereotactic system that is comparatively small, lightweight, user-friendly, and comparable in precision and accuracy to current clinical systems.
Methods:
Subjects will be recruited exclusively from adult subjects with a neurological disease. These subjects will be identified preoperatively from DBS clinical subjects. Each subject will undergo an evaluation by the Mayo Clinic Deep Brain Stimulation Committee (comprised of neurologists, neuropsychologists, psychiatrists, neurosurgeons, and radiologists) to receive a DBS surgery at Mayo Clinic - Rochester for the treatment of a neurological disease. All subjects will be pre-screened against the standard Mayo Clinic inclusion/exclusion criteria for DBS surgery through face-to-face interviews. Once a subject has been identified, the Study Coordinator will contact the subject for interest in participation in the study.
Step-by-Step Schedule:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
盲法说明
No other parties will be masked
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be adult subjects with medically intractable neurological disorder who have been approved for DBS surgery by the interdisciplinary Mayo DBS committee.
- •Competent and willing to provide signed, informed consent to participate in the study.
- •Competent and willing to provide written, informed consent to participate in the study.
排除标准
- •Pregnant subjects, prisoners, individuals ages less than 18 and any subjects identified as unsuitable for DBS surgery by the Mayo Clinic DBS committee.
- •Subjects unable to communicate with the investigator and staff.
- •Any health condition that in the investigator's opinion should preclude participation in this study.
研究组 & 干预措施
D1 Stereotactic System Assessment
Participants in the clinical study will consist of subjects approved to undergo deep brain stimulation surgery for the treatment of a neurological disorder at Mayo Clinic. Subjects will have a Key secured to their skull for attachment of an MRI-compatible localizer box or D1 stereotactic frame. 3D Euclidian distance error(s), trajectory accuracy(s), operating room time, and comfort level of the system will be assessed.
干预措施: DBS Electrode Implantation using D1 Sterotactic System (Device)
结局指标
主要结局
Comfort level questionnaire
时间窗: Within 1 month post-DBS surgery.
Comfort level questionnaire will be given to each subject after DBS surgery and removal of the device to assess their overall experience with device and surgery.
Trajectory accuracy
时间窗: Within 1 month post-DBS surgery.
A trajectory accuracy will be determined by comparing Collar Angle (CA) and Arc Angle (AA) between MR planned angles (CAP and AAP) and CT confirmed actual angles (CAA and AAA). The non-significant difference between MR planned and CT confirmed angles will be accounted as success criteria.
Operating room time
时间窗: Within 1 month post-DBS surgery.
Operating room time will be counted and compared to conventional procedure (using Leksell frame). The average operating room time will be compared between conventional procedure and D1 Stereotactic System procedure. Significantly lower operating room time will be accounted as success criteria
3D Euclidian distance error
时间窗: Within 1 month post-DBS surgery.
3D Euclidian distance error between the MR planned coordinate (XP, YP, ZP) and CT confirmed actual DBS coordinate (XA, YA, ZA) will be calculated. The 3D distance error comparable or lower to conventional system will be accounted as success criteria.
次要结局
未报告次要终点
研究者
Kai J. Miller
Principle Investigator
Mayo Clinic