Non-blinded Data Collection Study of Concussion Using the BrainPulse(TM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 406
- 试验地点
- 3
- 主要终点
- Number of BrainPulse recordings from suspected and confirmed concussed subjects
研究概览
简要总结
The multi-center study evaluates BrainPulse recordings from subjects with a suspected or confirmed concussion to improve a concussion detection algorithm. Subjects may also consent for a 5 additional follow-ups over a 21-day period to compare the progression of change in their BrainPulse recordings.
详细描述
The primary objective of this study is to collect un-blinded BrainPulse recordings from youth and adults that have a confirmed diagnosis of concussion per protocol guidelines in order to improve a concussion detection algorithm previously developed by Jan Medical, Inc. In order to gather sufficient variability, subjects with both confirmed concussion and suspected concussion will be included in the study as long as they meet eligibility criteria. BrainPulse recordings from subjects with suspected concussion will be compared to the recordings of subjects diagnosed with concussion. Subjects will be followed for 21 days after the initial injury with BrainPulse recordings to study the subject's recovery process. The symptomatic evaluation, physical examination, and BrainPulse recordings will be entered in a database to assess clinical outcome and device utilization.
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
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 5 years old
- •Suspected or confirmed concussion by medical professional
- •Not more than 3 days since injury/trauma event
- •Willing and able to participate in all required study evaluations and allow access to medical testing and records
- •Signed informed consent/assent, and/or have a legally authorized representative willing to provide informed consent on behalf of the subject
- •Demonstrates a minimum of 3 of the following symptoms:
- •Pressure in head
- •Dizziness
- •Neck pain
- •Fatigue/ low energy
- •Nausea or vomiting
- •Irritability
- •Difficulty in concentrating/performing tasks
- •Memory impairment
- •Reduced tolerance to stress
- •Sensitivity to light
- •Difficulty balancing
- •Blurred vision
- •Confusion
- •More emotional than usual
- •Nervous/Anxious
- •Vacant stare
- •Delayed verbal/motor response
- •'Feeling like in a fog'
- •'Don't feel right'
排除标准
- •Wound or open laceration on the head in the area of one of the BrainPulse sensors that would impede use of the BrainPulse device
- •Any serious medical condition that in the opinion of the medical professional would impair ability to provide informed consent/assent or otherwise disqualify a patient from participation
- •Currently participating in or planning to participate in another clinical study during the course of the current clinical study
- •Implantation of any medical device in head (e.g. ventriculoperitoneal shunt)
结局指标
主要结局
Number of BrainPulse recordings from suspected and confirmed concussed subjects
时间窗: Through study completion, expected to be 1 year
The primary endpoint is to enroll and record BrainPulse signals from 500 subjects with a suspected concussion. To gather sufficiently diverse data, at least 300 participants will have had a confirmed diagnosis of concussion. The data will be used to improve the algorithm for aiding in the diagnosis of concussion.
次要结局
- Specificity: Percentage of BrainPulse recordings from suspected concussed subjects that do not have the signal pattern seen within BrainPulse recordings from confirmed concussed subjects(Through study completion, expected to be 1 year)