Data Collection and Analysis of Neuroimaging and Intraoperative Neurophysiological Monitoring (IONM) in Brainstem Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Data of direct brainstem stimulation and clinical outcome
研究概览
简要总结
The hypothesis is that the structural documentation and analysis of the data of demographics, neuroimaging, IONM and clinical outcomes can help to further standardize the use of such equipment for detecting the integrity of the corticospinal tracts.
We want to confirm that the retrospectively data analysis of neuroimaging, IONM and clinical outcomes does help to understand these methods better in the surgical management of brainstem lesions, and therefore, improve the safety of brainstem surgery.
详细描述
This will be a prospective data collection and retrospective data analysis study to investigate the effect of pre- and post-neuroimaging, intraoperative monitoring, and clinical outcome during the surgical management of brainstem lesions in our neurosurgical center. The data of demographics, neuroimaging, IONM and patients' outcomes will be acquired based on the medical records and follow-up visits. All data is stored in the personal file of the clinical information system for each patient. The expected duration of each subject's participation is confined to the surgery itself and the routine visits during the follow-up. The overall study duration is expected to collect all the brainstem surgery in next five years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 age 18 - 80 years' old
- •With lesions in or near the brainstem
- •Patients who are suitable for brainstem surgery
- •Patients who accept the surgery
- •Patients who signed the informed consent
排除标准
- •Patients age < 18 years
- •Patients who are not suitable for brainstem surgery (for example patients in coma, very small lesion, pregnancy)
- •Patients unlikely to attend the follow-up 12 months after surgery
结局指标
主要结局
Data of direct brainstem stimulation and clinical outcome
时间窗: 09/2020-12/2021
The measurement of stimulation intensity (in mA) and its corresponding neurophysiological outcome (positive or not), as well as the short- and long-term neurological outcome (mRS 0-6) help the standardization of direct brainstem stimulation and clinical outcome prediction
次要结局
未报告次要终点
研究者
Yang Yang, MD
Dr.
Cantonal Hospital of St. Gallen