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

NCT ID: NCT02812225

Last Updated: 2022-06-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 406 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2019-01-31

Brief Summary

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.

Detailed Description

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.

Conditions

Brain Concussion; Mild Traumatic Brain Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

BrainPulse

BrainPulse recordings will be obtained from patients when they come in to the ED after a trauma event. BrainPulse recordings will be also obtained from those subjects who also consent for follow-up.

BrainPulse

Intervention Type: 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.

Interventions

BrainPulse

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.

Intervention Type: DEVICE

Other Intervention Names

BrainPulse 1100

Eligibility Criteria

Inclusion Criteria

1. Age >= 5 years old

2. Suspected or confirmed concussion by medical professional

3. Not more than 3 days since injury/trauma event

4. Willing and able to participate in all required study evaluations and allow access to medical testing and records

5. Signed informed consent/assent, and/or have a legally authorized representative willing to provide informed consent on behalf of the subject

6. 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

1. Wound or open laceration on the head in the area of one of the BrainPulse sensors that would impede use of the BrainPulse device

2. 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

3. Currently participating in or planning to participate in another clinical study during the course of the current clinical study

4. Implantation of any medical device in head (e.g. ventriculoperitoneal shunt)

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jan Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beth Israel Deconess Medical Center Emergency Medicine

Boston, Massachusetts, United States

University of Cincinnati, Department of Emergency Medicine

Cincinnati, Ohio, United States

Mountain States Health Alliance

Johnson City, Tennessee, United States

Countries

United States

References

Auerbach PS, Baine JG, Schott ML, Greenhaw A, Acharya MG, Smith WS. Detection of concussion using cranial accelerometry. Clin J Sport Med. 2015 Mar;25(2):126-32. doi: 10.1097/JSM.0000000000000117.

Reference Type: BACKGROUND

PMID: 25010149 (View on PubMed)

Smith WS, Browne JL, Ko NU. Cranial Accelerometry Can Detect Cerebral Vasospasm Caused by Subarachnoid Hemorrhage. Neurocrit Care. 2015 Dec;23(3):364-9. doi: 10.1007/s12028-015-0118-9.

Reference Type: BACKGROUND

PMID: 25761424 (View on PubMed)

Coscia A, Stolz U, Barczak C, Wright N, Mittermeyer S, Shams T, Epstein S, Kreitzer N. Use of the Sports Concussion Assessment Tool 3 in Emergency Department Patients With Psychiatric Disease. J Head Trauma Rehabil. 2021 Sep-Oct 01;36(5):E302-E311. doi: 10.1097/HTR.0000000000000648.

Reference Type: DERIVED

PMID: 33656471 (View on PubMed)

Other Identifiers

JMC-1502

Identifier Type: -

Identifier Source: org_study_id