Skip to main content
OpenTrials
Completed

NCT Number: NCT02812225

Non-blinded Data Collection Study of Concussion Using the BrainPulse(TM)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Mild Traumatic Brain Injury Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beth Israel Deconess Medical Center Emergency Medicine, Boston, Massachusetts, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:
  • Headache
  • Pressure in head
  • Dizziness
  • Neck pain
  • Fatigue/ low energy
  • Nausea or vomiting
  • Irritability
  • Difficulty in concentrating/performing tasks
  • Memory impairment
  • Insomnia
  • Reduced tolerance to stress
  • Sensitivity to light
  • Difficulty balancing
  • Blurred vision
  • Confusion
  • More emotional than usual
  • Sadness
  • Nervous/Anxious
  • Vacant stare
  • Delayed verbal/motor response
  • 'Feeling like in a fog'
  • 'Don't feel right'

Exclusion criteria

  • 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)

Treatment and study plan

BrainPulse

Device

Jan Medical's BrainPulse measures the brain motion caused by pulsatile blood flow from the cardiac cycle, referred to as the BrainPulse signal. The BrainPulse measures skull acceleration in response to the brain motion using an array of sensors placed on the head.

Other names: BrainPulse 1100

Primary outcomes

  1. Number of BrainPulse recordings from suspected and confirmed concussed subjects

    Time frame: 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.

Secondary outcomes

  1. Specificity: Percentage of BrainPulse recordings from suspected concussed subjects that do not have the signal pattern seen within BrainPulse recordings from confirmed concussed subjects

    Time frame: Through study completion, expected to be 1 year

    The secondary endpoint is to compare the BrainPulse readings from patients with confirmed concussion with patients with a suspected concussion in order to study the differences and similarities between the signals. The specific signal patterns observed from confirmed concussed subjects' BrainPulse recordings will be evaluated against the BrainPulse recordings from suspected concussed subjects who are later confirmed to not have a concussion and the percentage of such subjects will be evaluated as part of the secondary outcome. This can be seen as a specificity evaluation.

Other outcomes

  1. Average number of days the signal pattern seen within BrainPulse recordings from confirmed concussed subjects from the initial recording persist over the course of the 21 day follow up period.

    Time frame: Through study completion, expected to be 1 year

    The tertiary endpoint is to assess the differences in BrainPulse recordings between the initial visit and each subsequent follow-up visit to better understand the recovery process post concussion.

Sponsors and collaborators

Lead sponsor

Jan Medical, Inc.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 24, 2016
Registry last updated
Jun 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.