Clinical trial NCT02812225: Non-blinded Data Collection Study of Concussion Using the BrainPulse(TM)
Official title: Non-blinded Data Collection Study of Concussion Using the BrainPulse(TM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Concussion
Mild Traumatic Brain Injury
Lead sponsor: Jan Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-24
Enrollment: 406
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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)

Primary outcomes:
measure: Number of BrainPulse recordings from suspected and confirmed concussed subjects
timeFrame: Through study completion, expected to be 1 year
Secondary outcomes:
measure: Specificity: Percentage of BrainPulse recordings from suspected concussed subjects that do not have the signal pattern seen within BrainPulse recordings from confirmed concussed subjects
timeFrame: Through study completion, expected to be 1 year
Other 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
Locations:
city: Boston
country: United States
facility: Beth Israel Deconess Medical Center Emergency Medicine
state: Massachusetts
city: Cincinnati
country: United States
facility: University of Cincinnati, Department of Emergency Medicine
state: Ohio
city: Johnson City
country: United States
facility: Mountain States Health Alliance
state: Tennessee
Study officials:
References:
citation: 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.
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.
citation: 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.