跳至主要内容
临床试验/NCT06480370
NCT06480370招募中不适用

Optimization of Transcranial Motor Evoked Potentials in Supratentorial Surgeries

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2025年2月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
203
试验地点
1
主要终点
threshold of stimulation and patient movement

研究概览

简要总结

This project aims to optimize the methodology to elicite transcranial motor evoked potentials in intraoperative neurophysiological monitoring of brain surgery. It includes accelerometer measurements and microscope video image to determine movement of the surgical field, making possible minimization of movement during brain stimulation.

详细描述

Background: During supratentorial brain surgery there is a risk of iatrogenic injury resulting in post-operative motor deficits. Intraoperative neurophysiological monitoring (IONM) can help surgeons avoid this outcome, while also expanding evidence of its prognostic and preventive benefit (1, 2). However, there are still pending issues, such as standardization of optimal methodologies for data acquisition and interpretation as well as technical improvement.

There are two main IONM strategies: mapping to localize nervous structures, and monitoring to provide real-time assessment of functional integrity (3). With respect to monitoring, muscle motor evoked potentials (MEPs) enable motor system assessment. They can be elicited by pulse train transcranial electric stimulation (TES) through scalp electrodes placed at standard 10-20 system sites (C1, C2, C3, C4, Cz-1cm, Cz+6cm), or at neuronavigation-guided scalp sites. The stimulation circuit consists of the user-selected anode and cathode sites chosen from the scalp electrodes (4). The stimulation parameters are user-selected pulse duration, interstimulus interval (ISI), number of pulses, and single train stimulation vs. double-train or multi-train facilitation. MEP threshold is the stimulation intensity required to elicit a certain number of MEPs with a predefined amplitude. The recording montage consists of user-selected recording electrode orientation and target muscles. Practitioner preferences for these technical aspects vary widely (5), and can influence monitoring efficacy.

During surgery, significant MEP deterioration from an earlier baseline indicates a warning based on various criteria such as amplitude reduction or threshold elevation (2). Warnings trigger rescue manoeuvres to recover MEPs. With reversible MEP deterioration (recovery to values above the warning level), a post-operative motor deficit might be prevented. Continuous real-time monitoring facilitates this favourable result by providing early warnings, and is therefore important. With irreversible MEP deterioration there is an increased risk of a motor deficit (1), and discontinuous intermittent monitoring may fail to help prevent this adverse outcome.

A major concern regarding TES MEPs is that the stimuli often produce movement of the surgical field, which entails the risk of the patient being harmed by surgical manoeuvres if they are not paused during the measurements (4). This can delay the surgical procedure and/or preclude real-time monitoring. Thus, there is a need to establish optimal TES MEP methodology that minimizes objectively assessed movement.

Objective: The hypothesis of this project is that MEP stimulation and recording paradigms can be optimized to minimize movement of the surgical field during supratentorial brain surgery. Consequently, the overall aim is to identify the most effective stimulation and recording techniques to maximize TES MEP performance by minimizing movement. The specific objectives are to determine:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • •Informed consent signed by the subject
  • •The patient has a supra-tentorial lesion requiring surgery
  • •The patient is undergoing neurosurgery with the use of MEP monitoring during surgery to protect functional tissue* (During routine preparation for the surgery, patients are checked for any relative contraindications as listed in the user manual of the ISIS IOM System (see p. 11, chapter 2.2.4 of the user manual). Every relative contraindication must be weighed against the risk and benefits of the measurement signals which are routinely needed for the surgical intervention. There are no absolute contraindications for the ISIS IOM System.)
  • •The patient is older than 18 years

排除标准

  • •No need for MEP monitoring
  • •Vulnerable subjects (pregnant, impaired consciousness)
  • •People who do not want to participate in the study
  • •Emergency procedures in which no consent was obtained before the operation
  • •Multiple surgeries on the same patient
  • •Preoperative non-affected arm or leg motor deficit (MRC <5), that is to say, no motor deficit of the arm or leg ipsilateral to the surgery
  • •Inhalational anesthesia
  • •Persisting neuromuscular blockade
  • •Impossibility to place the stimulating or recording electrodes in the appropriate site

研究组 & 干预措施

Study Arm

Experimental

Application of TES at different stimulation circuits, with different stimulation parameters and recording montages.

干预措施: ISIS IOM System (Device)

结局指标

主要结局

threshold of stimulation and patient movement

时间窗: during surgery

threshold of stimulation and patient movement quantified by an accelerometer placed on the forehead of the patient

次要结局

  • patient movement(during surgery)
  • subjective evaluation of magnitude of motion(end of surgery)
  • quantification of magnitude(end of surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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