Use of Handheld Dynamometer As a Novel Tool to Assess Motor Function During Awake Craniotomy for Brain Lesions Located Within or Adjacent to the Motor Cortex: a Single-Center Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Maximum grip strength (KgF) variability from preoperative baseline
研究概览
简要总结
The primary purpose of this study is to assess the feasibility, safety and reliability of the use of handheld dynamometry in evaluating intraoperative motor function for patients undergoing awake craniotomy for the resection of brain lesions located within or adjacent to the motor cortex.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years old.
- •Primary or Recurrent Brain tumors
- •Single brain lesion
- •Lesion within or adjacent to the motor cortex- Lesion located within the primary or supplementary motor area (Verified by preoperative fMRI and DTI).
排除标准
- •Patients < 18 years old.
- •Major comorbidities (congestive heart failure, severe chronic obstructive pulmonary disease, morbid obesity, obstructive sleep apnea).
- •Patients with cognitive, intellectual or psychiatric impairment that could affect the capacity of following instructions evaluated during preoperative neuropsychological testing.
研究组 & 干预措施
Cohort 2. Patients with brain lesions within or proximal to motor areas undergoing an AC
5 patient minimum
干预措施: Hand-held dynamometer (Device)
Cohort 1. Patients with brain lesions in non-motor areas undergoing an awake craniotomy (AC)
5 patient minimum
干预措施: Hand-held dynamometer (Device)
结局指标
主要结局
Maximum grip strength (KgF) variability from preoperative baseline
时间窗: 1 day
To validate the use of hand-held dynamometry as an adequate tool to monitor intraoperative motor function during AC, each patient will be baselined (mean of 6 consecutive measurements) during the preoperative neuropsychology evaluation. Variability from preoperative baseline will be calculated as a percentile \[ (Preoperative Baseline/ Intraoperative Baseline)/ Preoperative Baseline) \* 100\]
Operative Time (Minutes)
时间窗: 1 day
Defined as the duration of the procedure from the initiation of skin incision to the completion of skin closure according to anesthesia records. Measured in minutes.
Intraoperative maximum grip strength (KgF) baseline
时间窗: 1 day
Maximum grip strength (KgF) will be measured using hand-held dynamometry every 2 minutes from the time the patient awakes until the end of surgery. Intraoperative maximum grip strength baseline is defined as the mean of 3 consecutive measures with \<10% variability.
Intraoperative maximum grip strength (KgF) variability
时间窗: 1 day
To validate the use of hand-held dynamometry as an adequate tool to monitor intraoperative motor function during awake craniotomies (AC), maximum grip strength (KgF) will be measured every 2 minutes from the time the patient awakes to the end of surgery. The intra-individual variability will be defined as the percent difference between sets with 10% or greater defined as substantial variability.
次要结局
- Postoperative Maximum Grip Strength (KgF)(1 month)
- Correlation Coefficient (ρ) between hand-held dynamometry and manual motor testing during AC(1 day)
研究者
Kaisorn L. Chaichana
Principal Investigator
Mayo Clinic