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

Mild Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02812225
• Other study ID #: JMC-1502
• Status: Completed
• Start date: June 2016
• Est. completion date: January 2019

Study information

• Verified date: June 2022
• Source: Jan Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Jan Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	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.	Through study completion, expected to be 1 year
Primary	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	Specificity: Percentage of BrainPulse recordings from suspected concussed subjects that do not have the signal pattern seen within BrainPulse recordings from confirmed concussed subjects	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.	Through study completion, expected to be 1 year