Brain Injuries, TraumaticAheadCASNCT02477943
Objective Brain Function Assessment of mTBI/Concussion in College Athletes
An observational study of Brain Injuries, Traumatic and Concussion, Mild, run by BrainScope Company, Inc. at 11 sites in United States.
Trial summary
This study (Part 1) is designed to build a database including EEG, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal EEG based algorithm for the identification of concussion and tracking of recovery. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Brain Injuries, Traumatic, Concussion, Mild, Concussion, Brain
- What is being tested?
- BrainScope Ahead 200iD and Advanced MRI Neuroimaging
- Type of treatment
- Medical device
- How many people
- 520 participants
- Where
- 11 sitesUnited States
- Study dates
- 8 Aug 2015to 31 Jul 2017
- 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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Study population: Approximately 450 male and female student-athletes from participating universities or colleges will be invited to participate.
Who may be able to join
- Concussion-Injury subjects will be defined as follows: Any player who, based on independent clinical impression, is suspected of having suffered a concussion of any severity level, and on whom a routine clinical examination for concussion or head injury would have been conducted prior to implementation of this research protocol according to current standard practice.
- If loss of consciousness, total duration less than <20 minutes
- No evidence of abnormality visible on Computerized Tomography (CT) of the head related to the traumatic event (Note: neuroimaging is not required for enrollment)
- No hospital admission due to either head injury or collateral injuries for >24 hours.
- GCS is between 13-15.
Who cannot join
- Evidence of illicit drug usage
- Do not speak or read English
- Current CNS active prescription medications, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD)
- Skull abnormalities, e.g. metal plate
- History of brain surgery or neurological disease.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of New Mexico
Albuquerque, New Mexico, 87106
University of Texas - Austin
Austin, Texas, 78712
University of South Carolina
Columbia, South Carolina, 29208
Michigan State University
East Lansing, Michigan, 48824
University of Arkansas
Fayetteville, Arkansas, 72701
Baylor College of Medicine
Houston, Texas, 77030
Houston Methodist Hospital
Houston, Texas, 77030
University of Rochester Medical Center
Rochester, New York, 14642
University of Connecticut
Storrs, Connecticut, 06269
SUNY Upstate Medical University
Syracuse, New York, 13210
University of South Florida
Tampa, Florida, 33612
About this study
Official title: Objective Brain Function Assessment of mTBI From Initial Injury to Rehabilitation and Treatment Optimization in College Athletes
This study (Part 1) is designed to build a database including EEG, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal EEG based algorithm for the identification of concussion and tracking of recovery. In addition, neuroimaging will be conducted at time of injury and following Return to Play (RTP).
Read the detailed description
Injured/concussed subjects will be studied at time of injury, and at 3 follow-up time points following injury. Matched controls will be tested following the same schedule as the injured athletes. In addition, the study will include an additional pool of contact and non-contact athletes who are not head injured and will be assessed prior to the season and then after the season has ended. This data will be used to populate a database for the purpose of deriving a multimodal concussion index.
- Conditions
- Brain Injuries, Traumatic, Concussion, Mild, Concussion, Brain, Concussion, Intermediate, Concussion, Severe
- Being tested
- BrainScope Ahead 200iD, Advanced MRI Neuroimaging
- Keywords
- Concussion, Mild Traumatic Brain Injury, Sport Related Concussion
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrainScope Ahead 200iDDevice
The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT3), Electrophysiological Function; Neurocognitive Performance Assessment and a balance/sway measurement. BrainScope Ahead 200iD device will be used to perform EEG.
Advanced MRI NeuroimagingDevice
Also called Magnetic Resonance Imaging, Diffusion Tension Imaging
Diffusion tensor imaging (DTI) is a magnetic resonance imaging technique that enables the measurement of the restricted diffusion of water in tissue in order to produce neural tract images instead of using this data solely for the purpose of assigning contrast or colors to pixels in a cross sectional image.
| Study group | Role | What they receive |
|---|---|---|
| Injured and Matched Control Subject Pool | Injured subjects consist of athletes who are head injured and meet the inclusion/exclusion criteria. Injured subjects will be tested within 72 hours (3 days) of injury and at specified time points post injury. Matched control subjects will be tested at the same time intervals as the injured subject. BrainScope Battery will be performed at each time point and consists of the following components: brain electrical activity (EEG), neurocognitive performance assessment, balance/sway measurement, and clinical symptoms/assessments. In addition, a subset of injured and matched control subjects will receive advanced MRI/DTI neuroimaging at time of injury and following RTP. Receives: Device: BrainScope Ahead 200iD; Device: Advanced MRI Neuroimaging | |
| Pre-Season and Post-Season Subject Pool | This subject pool will consist of uninjured (not head injured) contact and non-contact athletes and will be tested at two time points - pre-season and post-season. These subjects will perform the same BrainScope Battery as the injured and matched control subjects at each time points. Receives: Device: BrainScope Ahead 200iD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Algorithm for Likelihood of being concussed
Create a database of brain electrical activity (EEG) and clinical information collected from athletes who sustain a concussion during organized sports.
Measured: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Secondary outcomes (1)
Advanced Neuroimaging in concussion
Exploration of changes in functional neuroimaging which occur with concussion and change in these measures over time.
Measured: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study start8 Aug 2015
- Primary completion20 Feb 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain Injuries, TraumaticStudies 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
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- BrainScope Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Leslie Prichep, Ph.D., Study director, BrainScope Company, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477943
- Sponsor's protocol ID
- 14-Ahead
- Acronym
- AheadCAS
- Status last verified
- May 2019
- First submitted
- 15 Jun 2015
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Covassin T, McGowan AL, Bretzin AC, Anderson M, Petit KM, Savage JL, Katie SL, Elbin RJ, Pontifex MB. Preliminary investigation of a multimodal enhanced brain function index among high school and collegiate concussed male and female athletes. Phys Sportsmed. 2020 Nov;48(4):442-449. doi: 10.1080/00913847.2020.1745717. Epub 2020 Mar 31.
PubMed 32228157
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Brain Function Assessment of mTBI From Initial Injury to Rehabilitation and Treatment Optimization in College Athletes
- ClinicalTrials.gov ID
- NCT02477943
- Acronym / sponsor ID
- AheadCAS / 14-Ahead
- Conditions
- Brain Injuries, Traumatic, Concussion, Mild, Concussion, Brain, Concussion, Intermediate, Concussion, Severe
- Keywords
- Concussion, Mild Traumatic Brain Injury, Sport Related Concussion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- BrainScope Company, Inc.Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- 8 Aug 2015 (actual)
- Primary completion
- 20 Feb 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 23 Jun 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.
This study (Part 1) is designed to build a database including EEG, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal EEG based algorithm for the identification of concussion and tracking of recovery. In addition, neuroimaging will be conducted at time of injury and following Return to Play (RTP).
Detailed description
Injured/concussed subjects will be studied at time of injury, and at 3 follow-up time points following injury. Matched controls will be tested following the same schedule as the injured athletes. In addition, the study will include an additional pool of contact and non-contact athletes who are not head injured and will be assessed prior to the season and then after the season has ended. This data will be used to populate a database for the purpose of deriving a multimodal concussion index.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injured and Matched Control Subject Pool | – | Device: BrainScope Ahead 200iD, Device: Advanced MRI NeuroimagingInjured subjects consist of athletes who are head injured and meet the inclusion/exclusion criteria. Injured subjects will be tested within 72 hours (3 days) of injury and at specified time points post injury. Matched control subjects will be tested at the same time intervals as the injured subject. BrainScope Battery will be performed at each time point and consists of the following components: brain electrical activity (EEG), neurocognitive performance assessment, balance/sway measurement, and clinical symptoms/assessments. In addition, a subset of injured and matched control subjects will receive advanced MRI/DTI neuroimaging at time of injury and following RTP. |
| Pre-Season and Post-Season Subject Pool | – | Device: BrainScope Ahead 200iDThis subject pool will consist of uninjured (not head injured) contact and non-contact athletes and will be tested at two time points - pre-season and post-season. These subjects will perform the same BrainScope Battery as the injured and matched control subjects at each time points. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Approximately 450 male and female student-athletes from participating universities or colleges will be invited to participate.
Key inclusion criteria (5 listed)
- Concussion-Injury subjects will be defined as follows: Any player who, based on independent clinical impression, is suspected of having suffered a concussion of any severity level, and on whom a routine clinical examination for concussion or head injury would have been conducted prior to implementation of this research protocol according to current standard practice.
Key exclusion criteria (5 listed)
- Evidence of illicit drug usage
- Do not speak or read English
- Current CNS active prescription medications, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD)
- Skull abnormalities, e.g. metal plate
- History of brain surgery or neurological disease.
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 |
|---|---|---|
| BrainScope Ahead 200iDThe BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT3), Electrophysiological Function; Neurocognitive Performance Assessment and a balance/sway measurement. BrainScope Ahead 200iD device will be used to perform EEG. | Device | Injured and Matched Control Subject Pool, Pre-Season and Post-Season Subject Pool |
| Advanced MRI NeuroimagingAlso: Magnetic Resonance Imaging, Diffusion Tension ImagingDiffusion tensor imaging (DTI) is a magnetic resonance imaging technique that enables the measurement of the restricted diffusion of water in tissue in order to produce neural tract images instead of using this data solely for the purpose of assigning contrast or colors to pixels in a cross sectional image. | Device | Injured and Matched Control Subject Pool |
Primary outcome
Algorithm for Likelihood of being concussed
Time frame: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Create a database of brain electrical activity (EEG) and clinical information collected from athletes who sustain a concussion during organized sports.
1 secondary outcome
Advanced Neuroimaging in concussion
Time frame: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
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 23 May 2019.
- Derived from this study: PubMed 32228157Covassin T, McGowan AL, Bretzin AC, Anderson M, Petit KM, Savage JL, Katie SL, Elbin RJ, Pontifex MB. Preliminary investigation of a multimodal enhanced brain function index among high school and collegiate concussed male and female athletes. Phys Sportsmed. 2020 Nov;48(4):442-449. doi: 10.1080/00913847.2020.1745717. Epub 2020 Mar 31.
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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.
Leslie Prichep, Ph.D. study director
BrainScope Company, Inc.
11 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 Injuries, Traumatic and Concussion, Mild, run by BrainScope Company, Inc. at 11 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 5 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: finished, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Algorithm for Likelihood of being concussed (time frame: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP). 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 NCT02477943, which also lists 1 linked publication.
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 23 May 2019.