Brain ConcussionNCT02812225
Non-blinded Data Collection Study of Concussion Using the BrainPulse(TM)
An observational study of Brain Concussion and Mild Traumatic Brain Injury, run by Jan Medical, Inc. at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Brain Concussion, Mild Traumatic Brain Injury
- What is being tested?
- BrainPulse
- Type of treatment
- Medical device
- How many people
- 406 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2016to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients presenting to a hospital emergency department with a mechanism of injury and clinical presentation that is consistent with concussion
Who may be able to join
- 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:
Show all 28Show fewer
- 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'
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Beth Israel Deconess Medical Center Emergency Medicine
Boston, Massachusetts, 02215
University of Cincinnati, Department of Emergency Medicine
Cincinnati, Ohio, 45267-0769
Mountain States Health Alliance
Johnson City, Tennessee, 37604
About this study
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.
Read the 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.
- Conditions
- Brain Concussion, Mild Traumatic Brain Injury
- Being tested
- BrainPulse
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrainPulseDevice
Also called BrainPulse 1100
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: BrainPulse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Through study completion, expected to be 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jan Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812225
- Sponsor's protocol ID
- JMC-1502
- Status last verified
- Jun 2022
- First submitted
- 20 Jun 2016
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: All primary and secondary outcome measures will be made available within 6 months of study completion.
Publications
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.
PubMed 25010149Smith 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.
PubMed 25761424Coscia 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.
PubMed 33656471
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-blinded Data Collection Study of Concussion Using the BrainPulse(TM)
- ClinicalTrials.gov ID
- NCT02812225
- Acronym / sponsor ID
- JMC-1502
- Conditions
- Brain Concussion, Mild Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Jan Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 24 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BrainPulse | – | Device: BrainPulseBrainPulse 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. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients presenting to a hospital emergency department with a mechanism of injury and clinical presentation that is consistent with concussion
Key inclusion criteria (28 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrainPulseAlso: BrainPulse 1100Jan 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. | Device | BrainPulse |
Primary outcome
Number of BrainPulse recordings from suspected and confirmed concussed subjects
Time frame: Through study completion, expected to be 1 year
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.
1 secondary outcome
Specificity: Percentage of BrainPulse recordings from suspected concussed subjects that do not have the signal pattern seen within BrainPulse recordings from confirmed concussed subjects
Time frame: Through study completion, expected to be 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Background: PubMed 25010149Auerbach 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.
- Background: PubMed 25761424Smith 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.
- Derived from this study: PubMed 33656471Coscia 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.
- Individual participant dataSharing planned: No. All primary and secondary outcome measures will be made available within 6 months of study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Concussion and Mild Traumatic Brain Injury, run by Jan Medical, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of BrainPulse recordings from suspected and confirmed concussed subjects (time frame: Through study completion, expected to be 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02812225, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.