TBI (Traumatic Brain Injury)MEDONCT04279431
Follow-up of MTBI Patients Discharged from the ED Using Standard Clinical Triage Including BrainScope One
An observational study of TBI (Traumatic Brain Injury) and Concussion, Brain, run by BrainScope Company, Inc. at 7 sites in United States.
Trial summary
The purpose of the study is to validate the clinical outcome in patients with closed head injuries (GCS 14-15, ages 18-85) who are being evaluated for head trauma, integrating the BrainScope One structural injury classifier (SIC) algorithm, with focus on SIC negative classification. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- TBI (Traumatic Brain Injury), Concussion, Brain, MTBI - Mild Traumatic Brain Injury
- What is being tested?
- EEG Recording, Neurocognitive Tests and Clinician Evaluation
- Type of treatment
- Medical device
- How many people
- 660 participants
- Where
- 7 sitesUnited States
- Study dates
- 25 May 2020to 30 Sep 2024
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: An estimated total of 660 patients (with target of 330 SIC negative patients) who are suspected of a traumatic, closed head injury within 3 days of injury, will be recruited from patients who enter the participating Hospital ED's as clinical sites for this study. Potential study subjects will be identified by the research staff based on the stated inclusion and exclusion criteria to determine their eligibility. Once identified, the research staff will recruit the subject for the study through an informed consent process. Participation in the study will not interfere with standard of care at the clinical sites.
Who may be able to join
- Patient can be of any gender;
- Patient must be admitted to the ED with a traumatic closed head injury within 72 hours of injury;
- Patient's Age must be ≥18 and <86 years old at time of enrollment;
- Patient must be Glasgow Coma Scale (GCS) 14-15 at time of BrainScope evaluation (even if GCS was lower prior to arrival e.g. at time of injury).
Who cannot join
- Patients with forehead, scalp, earlobe or skull abnormalities or other conditions that would prevent correct application of the electrode headset;
- Patients with Dementia, Parkinson's Disease, Multiple Sclerosis, brain tumors, history of brain surgery, evidence of acute psychosis or history of stroke with neurological deficit within the last year;
- Patients on anti-platelets, anti-coagulants, other than aspirin, currently receiving dialysis or in end-stage renal disease or current condition is "critical" in the opinion of the investigator;
- Patients with active fever defined as greater than 100oF or 37.7oC;
- Patients suffering from an open head injury or have suffered multi-trauma which requires hospitalization (for injuries not related to the head injury)
- Patients requiring advanced airway management (i.e. mechanical ventilation);
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- Patients currently receiving procedural sedation medications (e.g. benzodiazepine, anesthetic, NMDA receptor antagonist, or opioid agonist) Note: patient can be enrolled when they are no longer obtunded and have the capacity to consent;
- Pregnant women and prisoners;
- Patients who have had a Head CT scan for current traumatic injury event prior to screening.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Wayne State University - Detroit Receiving Hospital
Detroit, Michigan, 48201
Henry Ford Health System
Detroit, Michigan, 48202
Wayne State University - Sinai Grace Hospital
Detroit, Michigan, 48235
El Paso Medical Center
El Paso, Texas, 79905
Beaumont Hospital
Royal Oak, Michigan, 48073
Washington University - Barnes Jewish Hospital
St Louis, Missouri, 63110
Beaumont Hospital
Troy, Michigan, 48085
About this study
The purpose of the study is to validate the clinical outcome in patients with closed head injuries (GCS 14-15, ages 18-85) who are being evaluated for head trauma, integrating the BrainScope One structural injury classifier (SIC) algorithm, with focus on SIC negative classification. In addition, to assess functional impairment (concussion) in these patients, results from Brain Function Index (BFI) or Concussion Index (CI) algorithms will be used for analysis.
Read the detailed description
BrainScope One incorporates brain electrical activity (EEG, a proven electrophysiological core technology) and other multimodal assessment capabilities in a portable, point-of-care, non-invasive device containing algorithms designed to improve early identification, staging, and optimization of treatment for head injured patients (GCS 13-15) who are suspected of a brain injury. Structural Injury Classifier (SIC) provides objective results that indicate the likelihood of a structural brain injury being present, potentially visible on CT Scan. Brain Function Index (BFI) provides an objective measurement to determine the likelihood and severity of brain function impairment such as that seen in concussion/mTBI. The BFI is presented as a percentile compared to a normal corresponding population. Lastly, the Concussion Index (CI) was derived in the most recent BrainScope concussion assessment clinical study, and it is defined as a multivariate, multimodal index to assess the presence and severity of concussion and has been demonstrated to reliably reflect change over time.
The present study population targets those patients who sustained a head injury, have high GCS scores (14-15) and present mild symptoms, for whom the suspicion of structural brain injury is therefore low. Having a rapid, reliable, and sensitive assessment tool to aid in the triage of patients who are suspected of a traumatically induced structural brain injury could aid in appropriate and timely diagnosis and subsequent medical care. It may also result in more appropriate utilization of medical imaging (potentially having associated health risks) and reductions in hospitalizations. Patients discharged from the ED who were deemed to not require a CT scan will be followed-up for outcome.
- Conditions
- TBI (Traumatic Brain Injury), Concussion, Brain, MTBI - Mild Traumatic Brain Injury, Closed Head Injury
- Being tested
- EEG Recording, Neurocognitive Tests, Clinician Evaluation, 22-item CSI
- Keywords
- BrainScope, Closed Head Injury, Concussion, EEG Evaluation, Cognitive Evaluation, Concussion Symptom Inventory, mTBI
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion, Head Injuries, Closed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG RecordingDevice
EEG recording acquired on BrainScope One device.
Neurocognitive TestsOther
Cognitive performance tests performed on BrainScope One device.
Clinician EvaluationOther
Clinician evaluation performed as part of standard of care at the clinical site.
22-item CSIOther
Self assessed 22-item Concussion Symptom Inventory (CSI).
| Study group | Role | What they receive |
|---|---|---|
| SIC Negative | Subjects will include males and females ranging from ages 18 to 85 who are admitted to the ED with a traumatic, closed head injury within 3 days of injury. Subject will undergo site standard clinical ED evaluation and a BrainScope evaluation. The SIC negative group are those patients who obtain a 'Negative' result on the BrainScope One Structural Injury Classifier (SIC) algorithm. Receives: Device: EEG Recording; Other: Neurocognitive Tests; Other: Clinician Evaluation; Other: 22-item CSI | |
| SIC Positive/Equivocal | Subjects will include males and females ranging from ages 18 to 85 who are admitted to the ED with a traumatic, closed head injury within 3 days of injury. Subject will undergo site standard clinical ED evaluation and a BrainScope evaluation. The SIC positive group are those patients who obtain a 'Positive' or 'Equivocal' result on the BrainScope One SIC algorithm. Receives: Device: EEG Recording; Other: Neurocognitive Tests; Other: Clinician Evaluation; Other: 22-item CSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical utility of integration of BSC SIC into the triage of closed head injured patients.
Demonstrate the accuracy of the BrainScope Structural Injury Classifier (SIC) negative findings through repeated follow ups of those patients discharged from the ED without receiving a CT scan, as determined by the ED physician.
Measured: 30 days
Secondary outcomes (3)
High NPV adds confidence to the clinical decision not to scan when the BrainScope SIC is negative
For those who were BSC SIC negative and who are referred to CT due to clinician's decision, CT results will be obtained to assess the accuracy of BrainScope finding, this will allow an estimate of NPV.
Measured: After enrollment closure
Higher specificity in BSC SIC compared to Nexus II and CCHR could result in decrease of referral for unnecessary CT scans due to higher specificity.
Compare accuracy of Nexus II and CCHR Imaging rules to BrainScope in predicting true negatives
Measured: After enrollment closure
To correlate BFI and CI to the severity and duration of concussive symptom burden (measured by CSI)
The BFI/CI can help to inform the clinical decision on the likely of concussion at the time of injury in the ED environment and predict prolonged recovery.
Measured: After enrollment closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start25 May 2020
- Primary completion1 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBI (Traumatic Brain Injury)Studies 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
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BrainScope Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leslie S Prichep, Ph.D., Study director, BrainScope Company, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279431
- Sponsor's protocol ID
- MEDO-40
- Acronym
- MEDO
- Status last verified
- Aug 2024
- First submitted
- 19 Feb 2020
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of MTBI Patients Discharged from the ED Using Standard Clinical Triage Including BrainScope One
- ClinicalTrials.gov ID
- NCT04279431
- Acronym / sponsor ID
- MEDO / MEDO-40
- Conditions
- TBI (Traumatic Brain Injury), Concussion, Brain, MTBI - Mild Traumatic Brain Injury, Closed Head Injury
- Keywords
- BrainScope, Closed Head Injury, Concussion, EEG Evaluation, Cognitive Evaluation, Concussion Symptom Inventory, mTBI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- BrainScope Company, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 May 2020 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 21 Feb 2020 (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.
The purpose of the study is to validate the clinical outcome in patients with closed head injuries (GCS 14-15, ages 18-85) who are being evaluated for head trauma, integrating the BrainScope One structural injury classifier (SIC) algorithm, with focus on SIC negative classification. In addition, to assess functional impairment (concussion) in these patients, results from Brain Function Index (BFI) or Concussion Index (CI) algorithms will be used for analysis.
Detailed description
BrainScope One incorporates brain electrical activity (EEG, a proven electrophysiological core technology) and other multimodal assessment capabilities in a portable, point-of-care, non-invasive device containing algorithms designed to improve early identification, staging, and optimization of treatment for head injured patients (GCS 13-15) who are suspected of a brain injury. Structural Injury Classifier (SIC) provides objective results that indicate the likelihood of a structural brain injury being present, potentially visible on CT Scan. Brain Function Index (BFI) provides an objective measurement to determine the likelihood and severity of brain function impairment such as that seen in concussion/mTBI. The BFI is presented as a percentile compared to a normal corresponding population. Lastly, the Concussion Index (CI) was derived in the most recent BrainScope concussion assessment clinical study, and it is defined as a multivariate, multimodal index to assess the presence and severity of concussion and has been demonstrated to reliably reflect change over time.
The present study population targets those patients who sustained a head injury, have high GCS scores (14-15) and present mild symptoms, for whom the suspicion of structural brain injury is therefore low. Having a rapid, reliable, and sensitive assessment tool to aid in the triage of patients who are suspected of a traumatically induced structural brain injury could aid in appropriate and timely diagnosis and subsequent medical care. It may also result in more appropriate utilization of medical imaging (potentially having associated health risks) and reductions in hospitalizations. Patients discharged from the ED who were deemed to not require a CT scan will be followed-up for outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIC Negative | – | Device: EEG Recording, Other: Neurocognitive Tests, Other: Clinician Evaluation, Other: 22-item CSISubjects will include males and females ranging from ages 18 to 85 who are admitted to the ED with a traumatic, closed head injury within 3 days of injury. Subject will undergo site standard clinical ED evaluation and a BrainScope evaluation. The SIC negative group are those patients who obtain a 'Negative' result on the BrainScope One Structural Injury Classifier (SIC) algorithm. |
| SIC Positive/Equivocal | – | Device: EEG Recording, Other: Neurocognitive Tests, Other: Clinician Evaluation, Other: 22-item CSISubjects will include males and females ranging from ages 18 to 85 who are admitted to the ED with a traumatic, closed head injury within 3 days of injury. Subject will undergo site standard clinical ED evaluation and a BrainScope evaluation. The SIC positive group are those patients who obtain a 'Positive' or 'Equivocal' result on the BrainScope One SIC algorithm. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- An estimated total of 660 patients (with target of 330 SIC negative patients) who are suspected of a traumatic, closed head injury within 3 days of injury, will be recruited from patients who enter the participating Hospital ED's as clinical sites for this study. Potential study subjects will be identified by the research staff based on the stated inclusion and exclusion criteria to determine their eligibility. Once identified, the research staff will recruit the subject for the study through an informed consent process. Participation in the study will not interfere with standard of care at the clinical sites.
Key inclusion criteria (4 listed)
Key exclusion criteria (9 listed)
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 |
|---|---|---|
| EEG RecordingEEG recording acquired on BrainScope One device. | Device | SIC Negative, SIC Positive/Equivocal |
| Neurocognitive TestsCognitive performance tests performed on BrainScope One device. | Other | SIC Negative, SIC Positive/Equivocal |
| Clinician EvaluationClinician evaluation performed as part of standard of care at the clinical site. | Other | SIC Negative, SIC Positive/Equivocal |
| 22-item CSISelf assessed 22-item Concussion Symptom Inventory (CSI). | Other | SIC Negative, SIC Positive/Equivocal |
Primary outcome
Clinical utility of integration of BSC SIC into the triage of closed head injured patients.
Time frame: 30 days
Demonstrate the accuracy of the BrainScope Structural Injury Classifier (SIC) negative findings through repeated follow ups of those patients discharged from the ED without receiving a CT scan, as determined by the ED physician.
3 secondary outcomes
High NPV adds confidence to the clinical decision not to scan when the BrainScope SIC is negative
Time frame: After enrollment closure
Higher specificity in BSC SIC compared to Nexus II and CCHR could result in decrease of referral for unnecessary CT scans due to higher specificity.
Time frame: After enrollment closure
To correlate BFI and CI to the severity and duration of concussive symptom burden (measured by CSI)
Time frame: After enrollment closure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- 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.
Leslie S Prichep, Ph.D. study director
BrainScope Company, Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TBI (Traumatic Brain Injury) and Concussion, Brain, run by BrainScope Company, Inc. at 7 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 4 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: status not confirmed, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Results are not available in the source record.
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?
Clinical utility of integration of BSC SIC into the triage of closed head injured patients. (time frame: 30 days). 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 3 Sep 2024.