Clinical trial NCT02849002: Un-blinded Data Collection Study of Concussion Using the BrainPulse(TM)
Official title: Non-Blinded Data Collection Study Of Concussion Using The BrainPulse
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Mild Traumatic Brain Injury
Keywords: Concussion
Lead sponsor: Jan Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-29
Enrollment: 25
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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)

Detailed description: Jan Medical is conducting a data collection study with the goal of developing further insight into understanding the signal features within a BrainPulse recording that are only present when the subject has a confirmed concussion. The initial pilot blinded study with Stanford University showed that there is increased energy in the 8-15 Hz range for BrainPulse recordings from adolescent male football players with a confirmed concussion. The current un-blinded study is designed to record the BrainPulse signal from a more diverse subject population to represent patients who have been diagnosed with a concussion in clinic setting. Subjects will include males and females ages 13 and older.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Number of BrainPulse recordings from suspected and confirmed concussed subjects
timeFrame: Through study completion, expected to be 6 months
Secondary outcomes:
measure: 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.
timeFrame: Through study completion, expected to be 1 year]
Other outcomes:
Locations:
city: Woodbridge
country: Canada
facility: Konkussion Inc.
state: Ontario
Study officials:
affiliation: Konkussion
name: Neilank Jha, MD
role: PRINCIPAL_INVESTIGATOR
References: