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

NCT02812225 | Completed DMC

• 1 other identifier: JMC-1502
• Study Type: observational
• Target: 406
• Locations: 1 country
• Sites: 3

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.

Conditions

Brain Concussion; Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Number of BrainPulse recordings from suspected and confirmed concussed subjects

  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.

  Through study completion, expected to be 1 year

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

  Through study completion, expected to be 1 year

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.

  Through study completion, expected to be 1 year

Study Arms (1)

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.

Device: BrainPulse

Interventions

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.

Also known as: BrainPulse 1100

BrainPulse

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients presenting to a hospital emergency department with a mechanism of injury and clinical presentation that is consistent with concussion

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jan Medical, Inc.: lead

Study Sites (3)

Beth Israel Deconess Medical Center Emergency Medicine

Boston, Massachusetts, 02215, United States

Location

University of Cincinnati, Department of Emergency Medicine

Cincinnati, Ohio, 45267-0769, United States

Location

Mountain States Health Alliance

Johnson City, Tennessee, 37604, United States

Location

Related Publications (3)

• 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.

  PMID: 25010149 BACKGROUND

• 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.

  PMID: 25761424 BACKGROUND

• 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.

  PMID: 33656471 DERIVED

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 24, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: June 9, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)