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临床试验/NCT05474066
NCT05474066招募中不适用

Pilot Trial Examining the Impact of Training Related Sub-Concussive Forces On Cognition and Selected Electroencephalogram Measures In Canadian Special Forces Members

Canadian Forces Health Services Centre Ottawa1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年8月1日最近更新:
适应症

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
Event Related Potential Changes

研究概览

简要总结

This study looks to investigate the cognitive effects associated with intense, military combat training regimens or so-called repetitive sub-concussive forces. Specifically, study participants will undergo cognitive testing in tandem with EEG recordings pre- and post-military training to assess cognition.

详细描述

Background Despite the high prevalence of cognitive issues in Veterans and active military personnel, there is relatively little understanding regarding the cognitive effects following intense, military training regimens designed to reflect a combat environment and blast exposure. Anecdotal evidence has shown that soldiers complain of cognitive issues post-training similar to those who have sustained brain trauma. Accordingly, this study looks to investigate the cognitive effects associated with intense, military combat training regimens or so-called repetitive sub-concussive forces. Specifically, study participants will undergo cognitive testing in tandem with EEG recordings pre- and post-military training to assess cognition.

Research Objective To assess the effects of repetitive, sub-concussive exposure (RSCE) on cognitive functioning and brain electrophysiology in Special Operation Forces (SOF) personnel. Furthermore, the relation between repetitive sub-concussive exposure and symptoms will be clarified.

Participants and Procedure 20 SOF members will complete a symptom profile, a vestibular ocular motor screening (VOMS), ImPACTTM Cognitive Testing and VoxNeuroTM Electroencephalogram (EEG) assessment pre-and post-training to assess cognitive functioning in the following domains: attention and concentration, working memory, and information processing. Investigators will look for correlations pre and post training

The cognitive assessment(s) to be taken are:

  1. ImPact Cognitive Testing
  2. VoxNeuro Assessment (EEG)

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ● Male or female between 18 and 65
  • Normal or corrected to normal vision and hearing (Note: If the patient has hearing aids or wears glasses, they are still able to complete the assessment. They will need to remove hearing aids for the Attention & Concentration and Information Processing test)
  • Sit still for 10-15 minutes
  • Understand basic instructions of cognitive tests

排除标准

  • ● Metal plates under their scalp that cross the midline
  • Taking epilepsy medications
  • History of neurologic or neuropsychiatric disorder prior to concussion in controls
  • Taking psychotropic medications
  • History of complete deafness
  • Supplements or performance enhancing drugs that can affect brain function

结局指标

主要结局

Event Related Potential Changes

时间窗: baseline and within 1 week of completion of 4 week training course

changes on selected event related potentials (ie N100, P200, N200, P300, N400) when testing attention, concentration, continuous visual memory, executive function and comprehension

次要结局

  • VOMS(baseline and within 1 week of completion of 4 week training course)
  • Impact Cognitive testing(baseline and within 1 week of completion of 4 week training course)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gaurav Gupta

Co Investigator

Canadian Forces Health Services Centre Ottawa

研究点 (1)

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