Brain ConcussionNCT02350699
Control Study of Nautilus BrainPulse for the Detection of Concussion
An observational study of Brain Concussion, run by Jan Medical, Inc. at 1 site in United States.
Trial summary
To use the Nautilus BrainPulse to compare and contrast the signal patterns from this cohort's signal patterns with those of concussed high school athletes. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Concussion
- What is being tested?
- Nautilus BrainPulse
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to May 2015
- 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 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Subjects who are healthy controls and participate in a non-contact sport at the high school level.
Who may be able to join
- Male and female between 14 and 19 years of age
- Participating in non-contact sport at the Freshman, JV, and varsity level in a Bay Area High School
- Able to provide signed informed consent or have a legally authorized representative willing to provide informed consent on the subject's behalf
Who cannot join
- History, if any, of concussion or stroke
- History, if any, of alcohol or drug abuse
- History, if any, of mental disorder or cerebrovascular disorder
- Pregnant women
- Failure to comply with recording schedule
- Not suitable for participation in the study in the opinion of the PI
Show all 9Show fewer
- Have suffered a concussion during the study
- Plays a contact sport (ex- football, lacrosse, basketball, soccer, ice hockey, cross-country)
- Related to a Jan Medical employee
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non Blinded Control Study of High School Athletes in Non Contact Sports
To use the Nautilus BrainPulse to compare and contrast the signal patterns from this cohort's signal patterns with those of concussed high school athletes.
Read the detailed description
This study is a non-blinded study in high school athletes who will be presumed to no be suffering from a concussion. Healthy controls will be recruited from high school sports that are not associated with physical contact, which could generate concussions.
The primary objective of this study is to improve Jan Medical's signal analysis. Jan Medical will perform analysis.
- Conditions
- Brain Concussion
- Being tested
- Nautilus 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.
Nautilus BrainPulseDevice
A noninvasive device to detect concussion utilizing headset and sensors
| Study group | Role | What they receive |
|---|---|---|
| Control | Nautilus BrainPulse Receives: Device: Nautilus BrainPulse |
What is being measured
The primary outcome is the main question the study is designed to answer.
To collect non-blinded Nautilus BrainPulseTM recordings from high school athletes who do not participate in a contact sport
BrainPulse recordings collected in this study will be used as an age-matched control cohort for comparison with already collected concussion data that is under development for identifying a concussion algorithm. The device recordings will be visually compared for similarities and differences using data mining practices looking for features that are consistent between the concussion subjects and healthy normals.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jan Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Lovoi, PhD, Principal investigator, Jan Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350699
- Sponsor's protocol ID
- Normal-001
- Status last verified
- Jun 2022
- First submitted
- 20 Jan 2015
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Blinded Control Study of High School Athletes in Non Contact Sports
- ClinicalTrials.gov ID
- NCT02350699
- Acronym / sponsor ID
- Normal-001
- Conditions
- Brain Concussion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Jan Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 30 Jan 2015 (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.
To use the Nautilus BrainPulse to compare and contrast the signal patterns from this cohort's signal patterns with those of concussed high school athletes.
Detailed description
This study is a non-blinded study in high school athletes who will be presumed to no be suffering from a concussion. Healthy controls will be recruited from high school sports that are not associated with physical contact, which could generate concussions.
The primary objective of this study is to improve Jan Medical's signal analysis. Jan Medical will perform analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control | – | Device: Nautilus BrainPulseNautilus BrainPulse |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Subjects who are healthy controls and participate in a non-contact sport at the high school level.
Key inclusion criteria (3 listed)
- Male and female between 14 and 19 years of age
- Participating in non-contact sport at the Freshman, JV, and varsity level in a Bay Area High School
- Able to provide signed informed consent or have a legally authorized representative willing to provide informed consent on the subject's behalf
Key exclusion criteria (9 listed)
- History, if any, of concussion or stroke
- History, if any, of alcohol or drug abuse
- History, if any, of mental disorder or cerebrovascular disorder
- Pregnant women
- Failure to comply with recording schedule
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 |
|---|---|---|
| Nautilus BrainPulseA noninvasive device to detect concussion utilizing headset and sensors | Device | Control |
Primary outcome
To collect non-blinded Nautilus BrainPulseTM recordings from high school athletes who do not participate in a contact sport
Time frame: 4 months
BrainPulse recordings collected in this study will be used as an age-matched control cohort for comparison with already collected concussion data that is under development for identifying a concussion algorithm. The device recordings will be visually compared for similarities and differences using data mining practices looking for features that are consistent between the concussion subjects and healthy normals.
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 6 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Paul Lovoi, PhD principal investigator
Jan Medical, Inc.
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 Brain Concussion, run by Jan Medical, Inc. at 1 site 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 3 inclusion and 9 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 6 Jul 2022. 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 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?
To collect non-blinded Nautilus BrainPulseTM recordings from high school athletes who do not participate in a contact sport (time frame: 4 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 6 Jul 2022.