Mild Traumatic Brain InjuryNCT02849002
Un-blinded Data Collection Study of Concussion Using the BrainPulse(TM)
An observational study of Mild Traumatic Brain Injury, run by Jan Medical, Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- BrainPulse
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jul 2016to 29 Sep 2016
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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:
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)
- An alternative diagnosis is made other than concussion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Blinded Data Collection Study Of Concussion Using The BrainPulse
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)
Read the 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.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- BrainPulse
- Keywords
- Concussion
- 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 |
|---|---|---|
| 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. 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
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.
Measured: 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.
The secondary 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.
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 posted29 Jul 2016 (estimated)
- Study start14 Jul 2016
- Primary completion29 Sep 2016
- Study completion29 Sep 2016
Why it stopped: Study was stopped at site due to insufficient funding to continue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jan Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neilank Jha, MD, Principal investigator, Konkussion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849002
- Sponsor's protocol ID
- JMC-1601-P01
- Status last verified
- Jul 2023
- First submitted
- 25 Jul 2016
- Last updated
- 7 Jul 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. 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
- ClinicalTrials.gov ID
- NCT02849002
- Acronym / sponsor ID
- JMC-1601-P01
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- Concussion
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was stopped at site due to insufficient funding to continue
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Jan Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jul 2016 (actual)
- Primary completion
- 29 Sep 2016 (actual)
- Study completion
- 29 Sep 2016 (actual)
- First posted
- 29 Jul 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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Device | – | Device: BrainPulseThe 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. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (28 listed)
- 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.
Key exclusion criteria (5 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)
- An alternative diagnosis is made other than concussion
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 | Interventional Device |
Primary outcome
Number of BrainPulse recordings from suspected and confirmed concussed subjects
Time frame: Through study completion, expected to be 6 months
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.
1 secondary outcome
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.
Time frame: Through study completion, expected to be 1 year]
Results and safety
The study was stopped early (reason given: Study was stopped at site due to insufficient funding to continue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
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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.
Neilank Jha, MD principal investigator
Konkussion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Traumatic Brain Injury, run by Jan Medical, Inc. at 1 site in Canada.
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 5 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: stopped early, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 was stopped early (reason given: Study was stopped at site due to insufficient funding to continue). Results are not available in the source record.
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 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2023.