The Effect of Intraoperative Cortical Stimulation on Hand Strength and Function During Awake Craniotomies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Hand strength - Manual Motor Scale (0-5)
研究概览
简要总结
The neurosurgical standard of care for treating a patient with a tumor invading hand primary motor cortex (M1) includes performing a craniotomy with intraoperative direct electrical stimulation (DES) mapping and to resect as much tumor as possible without a resultant permanent neurological deficit. However, the subjective nature of current intraoperative hand motor assessments do not offer a comprehensive understanding of how hand strength and function may be impacted by resection. Additionally, there is a paucity of data to inform how altering DES parameters may effect motor mapping. Here, the investigators seek to demonstrate a feasible, standardized protocol to quantitatively assess hand strength and function and systematically assess several stimulation parameters to improve intraoperative measurements and better understand how cortical stimulation interacts with underlying neural function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •AWAKE CRANIOTOMY COHORT
- •Inclusion Criteria:
- •Age 18 - 75
- •Ability to understand a written informed consent document, and the willingness to sign it
- •Radiographic evidence of tumor on MRI (i.e. non-enhancing) invading primary motor cortex in the non-dominant hemisphere.
- •Karnofsky performance status (KPS) ≥ 70
- •Normal or near normal motor strength (i.e., at least 3/5 in relevant areas)
- •Normal or near normal speech (Can consistently name at least 4/5 cards)
- •Free of other illness, in the judgment of the investigator, that may shorten life expectancy
- •Willing and able to participate in all aspects of the study
排除标准
- •Presence of other malignancy not in remission
- •Evidence of bi-hemispheric or widespread tumor involvement
- •Medically high-risk surgical candidate
- •History of recent scalp or systemic infection
- •Presence of other implants or foreign bodies in the head
- •Inability to receive an MRI for any reason
- •Inability to receive cortical stimulation for any reason
- •Presence of implanted cardiac device (such as a pacemaker or defibrillator)
研究组 & 干预措施
Awake Craniotomy
干预措施: Intraoperative Brain Simulation - Alternate Stimulation Parameters (Procedure)
结局指标
主要结局
Change in Hand strength - Manual Motor Scale (0-5)
时间窗: Pre-op, intra-op, 1 week post-op and 3 months post-op; 2 visits 3 weeks apart for healthy volunteers
Quantitative assessment on a scale of 0 - 5 5 - normal strength 4 - give away weakness 3 - movement against gravity 2 - movement in anti-gravity position 1 - muscle twitch 0 - no movement
Change in Hand strength - Dynamometer grip and pinch strength (Newtons)
时间窗: Pre-op, intra-op, 1 week post-op and 3 months post-op; 2 visits 3 weeks apart for healthy volunteers
Scored using force production in kilograms (0-90) Standardized procedure for positioning
Chang in Hand function (Velocity)
时间窗: Pre-op, intra-op, 1 week post-op and 3 months post-op; 2 visits 3 weeks apart for healthy volunteers
The Cyberglove III collects data on the movement of the joints in the hand. Subjects will be asked to wear the Cyberglove III while doing various tasks. Velocity will be measured in degrees per second.
Chang in Hand function (Finger Individuation)
时间窗: Pre-op, intra-op, 1 week post-op and 3 months post-op; 2 visits 3 weeks apart for healthy volunteers
The Cyberglove III collects data on the movement of the joints in the hand. Subjects will be asked to wear the Cyberglove III while doing various tasks. Finger individuation will be calculated using joint angles.
Chang in Hand function (Smoothness)
时间窗: Pre-op, intra-op, 1 week post-op and 3 months post-op; 2 visits 3 weeks apart for healthy volunteers
The Cyberglove III collects data on the movement of the joints in the hand. Subjects will be asked to wear the Cyberglove III while doing various tasks. Smoothness will be calculated using joint angles.
次要结局
未报告次要终点
研究者
Max Krucoff, MD
Assistant Professor of Neurological Surgery
Medical College of Wisconsin