Brain Injuries, TraumaticCAS13-25VNCT03671083
Validation of Brain Function Assessment Algorithm for mTBI/Concussion
An observational study of Brain Injuries, Traumatic and Concussion, Mild, run by BrainScope Company, Inc. at 5 sites in United States.
Trial summary
This study is Part 2 of data collection from 13-25 years old subject population for validation of previously derived algorithms. This data will be combined with that collected under NCT02957461 (Part 1 with subject age range 18-25 years) for the final analyses of validation of the algorithms. 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, Severe
- What is being tested?
- BrainScope Ahead 300iP
- Type of treatment
- Medical device
- How many people
- 309 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Oct 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 160 Injured and Matched Control 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
5 sites in 1 country.
5 sites in 1 country
United States5 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
Washington University
St Louis, Missouri, 63110
About this study
Official title: Validation of Brain Function Assessment Algorthm for mTBI From Initial Injury to Rehabilitation and Treatment Optimization in Concussion Clinics
This study is Part 2 of data collection from 13-25 years old subject population for validation of previously derived algorithms. This data will be combined with that collected under NCT02957461 (Part 1 with subject age range 18-25 years) for the final analyses of validation of the algorithms.
Read the detailed description
EEG, neurocognitive performance and clinical data will be collected at time of injury (within 3 days) at clinically determined Return to Play (RTP) and 45 days after RTP, for the purpose of independently validating the performance of the algorithms developed in prior studies (NCT02477943, NCT02661633 and NCTXXXXXX). Data collected under this study will be combined with that collected under NCT02957461 for the final analyses of prospective algorithm performance in an independent population ages 13-25 years. 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.
- Conditions
- Brain Injuries, Traumatic, Concussion, Mild, Concussion, Severe, Concussion, Intermediate, Concussion, Brain
- Being tested
- BrainScope Ahead 300iP
- Keywords
- Concussion, Sports Related Concussion, Mild Traumatic Brain Injury, 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, 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.
Likelihood of being concussed
Sensitivity and specificity forthe identification of the likelihood of concussion/mTBI at the time of injury using a multi-modal EEG-based Concussion Index (CI)
Measured: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Secondary outcomes (2)
Significance of change over time
Significant difference in concussion index between time of injury and return to play (RTP)
Measured: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Prediction of prolonged recovery
Accuracy of prediction of prolonged recovery from injury assessment using a multi-modal EEG-based concussion index
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 posted14 Sep 2018
- Study start1 Oct 2018
- Primary completion1 Mar 2019
- Study completion29 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 309 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
- NCT03671083
- Sponsor's protocol ID
- 52-Ahead
- Acronym
- CAS13-25V
- Status last verified
- May 2019
- First submitted
- 10 Aug 2018
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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
- Validation of Brain Function Assessment Algorthm for mTBI From Initial Injury to Rehabilitation and Treatment Optimization in Concussion Clinics
- ClinicalTrials.gov ID
- NCT03671083
- Acronym / sponsor ID
- CAS13-25V / 52-Ahead
- Conditions
- Brain Injuries, Traumatic, Concussion, Mild, Concussion, Severe, Concussion, Intermediate, Concussion, Brain
- Keywords
- Concussion, Sports Related Concussion, Mild Traumatic Brain Injury, Non-Sport Related Concussion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- BrainScope Company, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 29 Mar 2019 (actual)
- First posted
- 14 Sep 2018 (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 is Part 2 of data collection from 13-25 years old subject population for validation of previously derived algorithms. This data will be combined with that collected under NCT02957461 (Part 1 with subject age range 18-25 years) for the final analyses of validation of the algorithms.
Detailed description
EEG, neurocognitive performance and clinical data will be collected at time of injury (within 3 days) at clinically determined Return to Play (RTP) and 45 days after RTP, for the purpose of independently validating the performance of the algorithms developed in prior studies (NCT02477943, NCT02661633 and NCTXXXXXX). Data collected under this study will be combined with that collected under NCT02957461 for the final analyses of prospective algorithm performance in an independent population ages 13-25 years. 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.
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 160 Injured and Matched Control 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, 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
Likelihood of being concussed
Time frame: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Sensitivity and specificity forthe identification of the likelihood of concussion/mTBI at the time of injury using a multi-modal EEG-based Concussion Index (CI)
2 secondary outcomes
Significance of change over time
Time frame: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Prediction of prolonged recovery
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.
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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.
5 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 5 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 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 5 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?
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?
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.