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

NCT02849002 | Terminated

• 1 other identifier: JMC-1601-P01
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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.BrainPulse(TM)

Conditions

Mild Traumatic Brain Injury

Keywords

Concussion

Outcome Measures

Primary Outcomes (1)

• Number of BrainPulse recordings from suspected and confirmed concussed subjects

  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.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 6 months

Secondary 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)

Interventional Device

The BrainPulse is used on a patient's head to non-invasively detect, amplify and capture the brain motion caused by pulsatile blood flow from the cardiac cycle. The BrainPulse consists of a reusable headset that contains the accelerometers used to measure motion caused by pulsatile blood flow. The system is powered by rechargeable battery pack. The headset is placed on the subject's head and outputs data to a data collector that forwards the data to the computer. Each accelerometer has an attached tip that makes contact with the subject's head through hair. The headset also includes a photoplethysmograph (PPG) that simultaneously captures the subject's heart-rate information. There is no energy delivered to the brain or subject by these highly sensitive sensors.

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

Interventional Device

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children and adults, ages 13 and older, who are diagnosed with a concussion or mild Traumatic Brain Injury (mTBI), typically due to a trauma event such as a fall, sports injury, motor vehicle accident, etc.

You may qualify if:

• Age \> 13 years old and not part of any other vulnerable population such as pregnant women.
• 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)
• An alternative diagnosis is made other than concussion

Sponsors & Collaborators

• Jan Medical, Inc.: lead

Study Sites (1)

Konkussion Inc.

Woodbridge, Ontario, L4L9R6, Canada

Location

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 Officials

• Neilank Jha, MD

  Konkussion

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: July 29, 2016
• Study Start: July 14, 2016
• Primary Completion: September 29, 2016
• Study Completion: September 29, 2016
• Last Updated: July 7, 2023

Record last verified: 2023-07

Locations

CA (1)