跳至主要内容
临床试验/NCT06901310
NCT06901310Enrolling By Invitation不适用

Effectiveness of Recruitment, Retention Strategies, and Data Collection Quality: A Feasibility Study in Combat Athletes With Mild Traumatic Brain Injury

Michael Harl1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年8月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
10
试验地点
1
主要终点
Impact Neurological Scores

研究概览

简要总结

The use of Hyberbaric Oxygen Therapy (HBOT) would be a new treatment plan rather than conventional rest. If effective, this new use technology would add to the clinical treatment among mild traumatic brain injury (mTBI) patients. The use of a point of care Glial Fibrillary Acidic Protein (GFAP) biomarker would aid in clinical decision making to create a new care plan of return to sport among unarmed combat athletes who suffer from mTBI. The innovation would be a new treatment and diagnosis strategy that will protect these athletes from serious long-term sequelae. There are no published randomized controlled studies using HBOT to treat concussed athletes within one week of injury. There are no published studies using GFAP levels to predict post concussive symptoms (PCS).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •18 Years or older
  • •Male Unarmed Combat Athlete
  • •30-day suspension (head injury without technical knockout or incapacitation)
  • •60-day suspension (head injury with technical knockout or incapacitation)
  • •90-day suspension (head injury with loss of consciousness)

排除标准

  • •Prisoner status
  • •Suspension group injury severity would not include moderate to severe GCS <13
  • •These suspension groups are not based on GCS; therefore, GCS is not part of the inclusion criteria. This group will be divided into randomized groups, patients who will be treated with HBOT and patients who will receive the standard of care, which is rest.

研究组 & 干预措施

HBOT Treatment Group

Experimental

干预措施: Hyberbaric Oxygen Therapy (Device)

Conventional Rest Control Group

No Intervention

结局指标

主要结局

Impact Neurological Scores

时间窗: 13 Weeks

The Impact scores are a percentile 1% to 100%. Any score under 50% is considered a need for neurological or primary care consultation for a concussion

次要结局

未报告次要终点

研究者

发起方
Michael Harl
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michael Harl

Physician - Plastic Surgery

Marshfield Clinic Research Foundation

研究点 (1)

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