Brain Injuries, TraumaticCAS13-25NCT03963804
Objective Brain Function Assessment of mTBI/Concussion
An observational study of Brain Injuries, Traumatic and Concussion, Mild, run by BrainScope Company, Inc. at 4 sites in United States.
Trial summary
This study (Part 3) 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 13 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries, Traumatic, Concussion, Mild, Concussion, Intermediate
- What is being tested?
- BrainScope Ahead 300iP
- Type of treatment
- Medical device
- How many people
- 268 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Jun 2018to 29 Mar 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 13 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Approximately 490 Injured, Matched Control and Healthy Volunteer subjects will be recruited from high schools, college universities, concussion clinics and emergency rooms.
Who may be able to join
- For Injured subjects:
- Having sustained a traumatic closed head injury within 72 hours (3 days) from time of injury at time of BrainScope assessment;
- GCS 13-15 at time of BrainScope assessment;
- No hospital admission due to either head injury or collateral injuries for >24 hours.
- For Matched Controls:
- GCS 15 at time of BrainScope assessment;
- No prior history of concussion or TBI in the last year.
Who cannot join
- Previously enrolled in the BrainScope CAS Studies;
- Current CNS active prescription medications taken daily, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD) or Attention Deficit Hyperactivity Disorder (ADHD);
- Forehead, scalp or skull abnormalities that prevents headset application or EEG data collection;
- History of brain surgery or neurological disease;
- Pregnant women;
- Subjects who do not speak English (non-English speaking parents are allowed to consent so long as translation of the consent form in their native language is available);
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- Acute intoxication;
- Evidence of illicit drug usage;
- For Injured subjects:
- Loss of consciousness ≥ 20 minutes related to the concussion injury;
- Active fever defined as greater than 100ºF or 37.78ºC at time of BrainScope assessment;
- Evidence of abnormality visible on Computerized Tomography (CT) of the head related to the traumatic event (Note: neuroimaging is not required for enrollment).
- For Matched Controls:
- Any focal neurological signs including aphasia, apraxia, diplopia, facial droop, dysarthria/slurred speech;
- History of Motor Vehicle Accident (MVA) requiring an Emergency Department visit within the past 1 year.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Michigan State University
East Lansing, Michigan, 48824
University of Arkansas
Fayetteville, Arkansas, 72701
University of Miami
Miami, Florida, 33136
University of Rochester
Rochester, New York, 14642
About this study
Official title: Objective Brain Function Assessment of mTBI From Initial Injury to Rehabilitation in Concussion
This study (Part 3) 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 the detailed description
Injured/concussed subjects will be studied at time of injury, and at 3 follow-up time points following injury. Subjects will come from the sports and other populations of concussed individuals. They will be matched with controls i.e. not head injured subjects who will also undergo the same set of tests and the same time intervals as the injured subjects. An additional pool of uninjured (not head injured) subjects will be collected who will be assessed at a single time point. 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, Intermediate, Concussion, Severe, Concussion, Brain
- Being tested
- BrainScope Ahead 300iP
- Keywords
- Concussion, Mild Traumatic Brain Injury, Sport Related Concussion, Non-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 300iPDevice
The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT5), Electrophysiological Function; Neurocognitive Performance Assessment and Ocular Motor Assessment. BrainScope Ahead 300iP will be used to perform EEG and Cognitive assessments.
| Study group | Role | What they receive |
|---|---|---|
| Injured and Matched Control Subject Pool | Injured subjects consist of subjects 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, ocular motor assessment, and clinical symptoms/assessments. Receives: Device: BrainScope Ahead 300iP | |
| Healthy Volunteer Subject Pool | This subject pool will consist of uninjured (not head injured) subjects and will be tested at a single time point. These subjects will perform the same BrainScope Battery as the injured and matched control subjects. Receives: Device: BrainScope Ahead 300iP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Derivation of algorithm for Likelihood of being concussed using multimodal inputs
Create a database of all assessments including brain electrical activity (EEG features including all frequency bands and measures (power, connectivity,complexity), neurocognitive performance tests scores (throughput measures), balance, and clinical/symptom assessments (SCAT5), to support derivation of a multimodal brain function/concussion index. (NOTE: All EEG and Neurocognitive features are expressed as z-scores relative to age expected normal values to enable combination)
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 posted28 May 2019
- Study start11 Jun 2018
- Primary completion25 Jan 2019
- Study completion29 Mar 2019
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
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- BrainScope Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leslie Prichep, Ph.D., Study director, BrainScope Company, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963804
- Sponsor's protocol ID
- 31-Ahead
- Acronym
- CAS13-25
- Status last verified
- May 2019
- First submitted
- 21 May 2019
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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 28 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 in Concussion
- ClinicalTrials.gov ID
- NCT03963804
- Acronym / sponsor ID
- CAS13-25 / 31-Ahead
- Conditions
- Brain Injuries, Traumatic, Concussion, Mild, Concussion, Intermediate, Concussion, Severe, Concussion, Brain
- Keywords
- Concussion, Mild Traumatic Brain Injury, Sport Related Concussion, Non-Sport Related Concussion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- BrainScope Company, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 25 Jan 2019 (actual)
- Study completion
- 29 Mar 2019 (actual)
- First posted
- 28 May 2019 (actual)
- 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 3) 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.
Detailed description
Injured/concussed subjects will be studied at time of injury, and at 3 follow-up time points following injury. Subjects will come from the sports and other populations of concussed individuals. They will be matched with controls i.e. not head injured subjects who will also undergo the same set of tests and the same time intervals as the injured subjects. An additional pool of uninjured (not head injured) subjects will be collected who will be assessed at a single time point. 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 300iPInjured subjects consist of subjects 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, ocular motor assessment, and clinical symptoms/assessments. |
| Healthy Volunteer Subject Pool | – | Device: BrainScope Ahead 300iPThis subject pool will consist of uninjured (not head injured) subjects and will be tested at a single time point. These subjects will perform the same BrainScope Battery as the injured and matched control subjects. |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Approximately 490 Injured, Matched Control and Healthy Volunteer subjects will be recruited from high schools, college universities, concussion clinics and emergency rooms.
Key inclusion criteria (7 listed)
- Having sustained a traumatic closed head injury within 72 hours (3 days) from time of injury at time of BrainScope assessment;
- GCS 13-15 at time of BrainScope assessment;
- No hospital admission due to either head injury or collateral injuries for >24 hours.
- GCS 15 at time of BrainScope assessment;
- No prior history of concussion or TBI in the last year.
Key exclusion criteria (15 listed)
- Previously enrolled in the BrainScope CAS Studies;
- Current CNS active prescription medications taken daily, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD) or Attention Deficit Hyperactivity Disorder (ADHD);
- Forehead, scalp or skull abnormalities that prevents headset application or EEG data collection;
- History of brain surgery or neurological disease;
- Pregnant women;
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 300iPThe BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT5), Electrophysiological Function; Neurocognitive Performance Assessment and Ocular Motor Assessment. BrainScope Ahead 300iP will be used to perform EEG and Cognitive assessments. | Device | Healthy Volunteer Subject Pool, Injured and Matched Control Subject Pool |
Primary outcome
Derivation of algorithm for Likelihood of being concussed using multimodal inputs
Time frame: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Create a database of all assessments including brain electrical activity (EEG features including all frequency bands and measures (power, connectivity,complexity), neurocognitive performance tests scores (throughput measures), balance, and clinical/symptom assessments (SCAT5), to support derivation of a multimodal brain function/concussion index. (NOTE: All EEG and Neurocognitive features are expressed as z-scores relative to age expected normal values to enable combination)
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 28 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.
4 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 4 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 7 inclusion and 15 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 28 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 4 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?
Derivation of algorithm for Likelihood of being concussed using multimodal inputs (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 NCT03963804, 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 28 May 2019.