ConcussionNCT02370914
Concussion Testing: A Novel Non-invasive Concussion Detection Device
An observational study of Concussion, run by Jan Medical, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to establish and evaluate a distinctive signal for concussion. Read more about this study
- Who is it for?
- Ages 14 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Concussion
- What is being tested?
- Nautilus NeuroWaveTM System and SCAT
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Dec 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: Varsity high school football players at a local High School.
Who may be able to join
- Junior Varsity and Varsity Players a local High School.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to establish and evaluate a distinctive signal for concussion.
Read the detailed description
The purpose of this study is to establish a non-invasive objective measurement for the detection of concussions with the Jan Medical Device (JMD). The study will assess the ability of this device to demonstrate unique signals that correlate with concussions. The study will also test the athletes at baseline at rest and during exertion to determine if there is a difference in the signal from exertion alone. The JMD is a non-invasive band that is placed around the participants head. The JMD detects a unique pattern of signals based on displacement of the skull from changes in blood flow during individual heartbeats. The athletes will be tested longitudinally to assess to changes over time, in addition to changes after impact
- Conditions
- Concussion
- Being tested
- Nautilus NeuroWaveTM System, SCAT
- 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.
Nautilus NeuroWaveTM SystemDevice
Also called Jan Medical Nautilus NeuroWave
Recording of subjects with Nautilus NeuroWave diagnostic device
SCATBehavioural
Also called Sports Concussion Assessment Test, SCAT2
A Neurocognitive evaluation of the patients to assess for concussion.
| Study group | Role | What they receive |
|---|---|---|
| Suspected Concussive Event (SCE) | When a subject is suspected of a concussion, a Nautilus NeuroWaveTM System recording is obtained from the subject and the recording is evaluated by a Jan Medical concussion algorithm. The subject is declared concussed or not per the algorithm. This is compared to a Sport Concussion Assessment Tool (SCAT) test. Receives: Device: Nautilus NeuroWaveTM System; Behavioral: SCAT | |
| Control | All subjects at the start of study have a baseline recording using the Nautilus NeuroWaveTM System. These subjects are enrolled into the study as non-concussed and these recordings serve as control recordings. Additionally, some subjects from this cohort will be recorded again at the end of the study to obtain end of season recordings. These results are compared to a Sport Concussion Assessment Tool (SCAT) test. Receives: Device: Nautilus NeuroWaveTM System; Behavioral: SCAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Measure Assessing the Sensitivity and Specificity Rate Based on the Nautilus Neurowave Data
Sensitivity (also called the true positive rate) measures the proportion of concussed participants that are correctly identified as such by utilizing the information within the Nautilus Neurowave data. Specificity (also called the true negative rate) measures the proportion of non-concussed participants that are correctly identified as such by utilizing the information within the Nautilus Neurowave data
The information that is evaluated from within this data is recognized through the computation of two parameters, R1 and R2. Both R1 and R2 are measured by computing the frequency spectrum using an FFT of the Neurowave data and computing a ratio of the signal intensities at specific higher frequencies against specific lower frequencies within that spectrum. Based on this computation, the recorded data is evaluated as coming from a concussed participant if R1 >= 1.0 and R2 >= 0.66 and is considered non-concussed otherwise.
Measured: Individual assessments were made within 2 days of recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startAug 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jan Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul S Auerbach, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370914
- Sponsor's protocol ID
- 21114
- Status last verified
- Jul 2022
- First submitted
- 21 Feb 2014
- Last updated
- 2 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concussion Testing: A Novel Non-invasive Concussion Detection Device
- ClinicalTrials.gov ID
- NCT02370914
- Acronym / sponsor ID
- 21114
- Conditions
- Concussion
- Keywords
- Concussion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Jan Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2011 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Feb 2015 (estimated)
- Results
- Posted 20 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to establish and evaluate a distinctive signal for concussion.
Detailed description
The purpose of this study is to establish a non-invasive objective measurement for the detection of concussions with the Jan Medical Device (JMD). The study will assess the ability of this device to demonstrate unique signals that correlate with concussions. The study will also test the athletes at baseline at rest and during exertion to determine if there is a difference in the signal from exertion alone. The JMD is a non-invasive band that is placed around the participants head. The JMD detects a unique pattern of signals based on displacement of the skull from changes in blood flow during individual heartbeats. The athletes will be tested longitudinally to assess to changes over time, in addition to changes after impact
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suspected Concussive Event (SCE) | – | Device: Nautilus NeuroWaveTM System, Behavioral: SCATWhen a subject is suspected of a concussion, a Nautilus NeuroWaveTM System recording is obtained from the subject and the recording is evaluated by a Jan Medical concussion algorithm. The subject is declared concussed or not per the algorithm. This is compared to a Sport Concussion Assessment Tool (SCAT) test. |
| Control | – | Device: Nautilus NeuroWaveTM System, Behavioral: SCATAll subjects at the start of study have a baseline recording using the Nautilus NeuroWaveTM System. These subjects are enrolled into the study as non-concussed and these recordings serve as control recordings. Additionally, some subjects from this cohort will be recorded again at the end of the study to obtain end of season recordings. These results are compared to a Sport Concussion Assessment Tool (SCAT) test. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Varsity high school football players at a local High School.
Key inclusion criteria (1 listed)
- Junior Varsity and Varsity Players a local High School.
Key exclusion criteria (1 listed)
- None
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 NeuroWaveTM SystemAlso: Jan Medical Nautilus NeuroWaveRecording of subjects with Nautilus NeuroWave diagnostic device | Device | Control, Suspected Concussive Event (SCE) |
| SCATAlso: Sports Concussion Assessment Test, SCAT2A Neurocognitive evaluation of the patients to assess for concussion. | Behavioural | Control, Suspected Concussive Event (SCE) |
Primary outcome
A Measure Assessing the Sensitivity and Specificity Rate Based on the Nautilus Neurowave Data
Time frame: Individual assessments were made within 2 days of recording
Sensitivity (also called the true positive rate) measures the proportion of concussed participants that are correctly identified as such by utilizing the information within the Nautilus Neurowave data. Specificity (also called the true negative rate) measures the proportion of non-concussed participants that are correctly identified as such by utilizing the information within the Nautilus Neurowave data The information that is evaluated from within this data is recognized through the computation of two parameters, R1 and R2. Both R1 and R2 are measured by computing the frequency spectrum using an FFT of the Neurowave data and computing a ratio of the signal intensities at specific higher frequencies against specific lower frequencies within that spectrum. Based on this computation, the recorded data is evaluated as coming from a concussed participant if R1 >= 1.0 and R2 >= 0.66 and is considered non-concussed otherwise.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Concussion
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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 S Auerbach principal investigator
Stanford University
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 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 1 inclusion and 1 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 2 Aug 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?
Yes. Results are posted in the registry (first posted 20 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
A Measure Assessing the Sensitivity and Specificity Rate Based on the Nautilus Neurowave Data (time frame: Individual assessments were made within 2 days of recording). 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 2 Aug 2022.