Pre and Post-Operative Cognitive Status in Patients Undergoing Surgery for Resection of Meningioma Associated With the Frontal and Temporal Lobes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Overall cognitive function
研究概览
简要总结
The purpose of this prospectively enrolling trial is to assess long-term cognitive outcomes of patients undergoing surgery for resection of a meningioma associated with the frontal and temporal lobes.
详细描述
This study will look at patients who are undergoing resection of a skull based meningioma, located in the frontal or temporal lobe, via craniotomy or via endoscopic endonasal approach. The study will compare cognitive function at baseline, at six weeks postoperatively and at one year postoperatively. The cognitive testing being done at baseline will be a clinical care set of assessments done by the speech language pathology team and will include the RBANS tests, the MoCA, PROMIS-29, and NeuroQOL-Cognitive Functions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a meningioma associated with the frontal or temporal lobes
- •Subject is scheduled to undergo open craniotomy or Endoscopic Endonasal surgery
- •Subject is 18 years of age or older
- •The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent
- •Previous surgery will not exclude the patient as a new baseline cognitive evaluation will occur.
排除标准
- •Patient is a prisoner
- •Patient is 90 years of age or older
- •Pregnant women
- •Previous radiation to the brain
结局指标
主要结局
Overall cognitive function
时间窗: 12 months
Cognitive function will be compared at baseline and at one year post-operatively.
次要结局
- Cognitive function based on tumor location using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)(12 months)
- Cognitive function based on surgical approach using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)(12 months)
研究者
Daniel M. Prevedello
Clinical Professor
Ohio State University