Mild Traumatic Brain InjuryHeadSMART IINCT04423198
HEAD Injury Serum Markers and Multi-modalities for Assessing Response to Trauma
An observational study of Mild Traumatic Brain Injury, run by BRAINBox Solutions Inc at 11 sites in United States.
Trial summary
The goal of HeadSMART II (HEAD injury Serum markers and Multi-modalities for Assessing Response to Trauma II) is to develop an In-Vitro Diagnostic, the BRAINBox TBI test, to aid in the diagnosis and prognosis of patients with mild traumatic brain injury, by incorporating blood biomarkers, clinical assessments, and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- Cognitive Assessment, Patient Reported Neurological Outcome Assessments and Blood Draw
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 2,000 participants
- Where
- 11 sitesUnited States
- Study dates
- 31 Dec 2020to Dec 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects presenting to the Emergency Department or Urgent Care with a blunt head trauma.
Who may be able to join
- Age >=18 years
- Ability to provide a blood sample; within 96 hours of injury
- Ability to provide informed consent. Consent may be obtained with assistance of a legally authorized representative (LAR)
- Must present to the Emergency Department (ED) or Urgent Care (UC) with a blunt head trauma
- Age >=18 years
- Ability to provide a blood sample; (For Trauma Controls (TC's) within 96 hours of injury)
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- Ability to provide informed consent. (For TC's consent may be obtained with assistance of a legally authorized representative (LAR)
- Presents to the Emergency Department or Urgent Care with at least one injury requiring an X-Ray (TC's only)
- Healthy and not taking prescription medications (Healthy Controls (HC's) only)
Who cannot join
- Glasgow Coma Scale (GCS) score < 13, as presented in ED at time of screening
- Need for general anesthesia at the time of presentation in the ED
- Diagnosed dementia requiring assistance for daily living
- Any head trauma requiring medical attention from a physician within the last 6 months
- Received chemotherapy or radiation within the last year
- History of stroke with disabling outcomes, brain tumor, epilepsy or intracranial surgery/hemorrhage
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- Psychiatric hospitalization in the last 90 days
- Blood transfusion within the prior 4 weeks
- Non-working telephone number
- Current participant in an interventional clinical trial
- Cannot perform study tasks on an iPad (e.g. not wearing corrective lenses necessary to read, inability to use both hands)
- Subject considered unsuitable for participation in this clinical trial by PI, treating clinician or research study staff
- Control Subjects
- Head trauma or symptoms with head trauma at presentation
- Head trauma requiring medical attention from a physician within the last 6 months
- Internal organ injury (e.g. liver laceration, pulmonary contusion, spinal cord injury) that requires inpatient hospitalization
- Need for general anesthesia at the time of presentation in the ED
- Diagnosed dementia requiring assistance for daily living
- Received chemotherapy or radiation within the last year
- History of stroke with disabling outcomes, brain tumor, epilepsy or intracranial surgery/hemorrhage
- Psychiatric hospitalization in the last 90 days
- Blood transfusion within the prior 4 weeks
- Non-working telephone number
- Current participant in an interventional clinical trial
- Cannot perform study tasks on an iPad (e.g. not wearing corrective lenses necessary to read, inability to use both hands)
- Subject considered unsuitable for participation in this clinical trial by PI, treating clinician or research study staff
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
Detroit Receiving
Detroit, Michigan, 48201
Justin Sabol
Robert Welch, MD
- Recruiting
Harper University Hospital
Detroit, Michigan, 48201
Justin Sabol
Robert Welch, MD
- Recruiting
Sinai Grace Hospital
Detroit, Michigan, 48235
Justin Sabol
Robert Welch, MD
- Recruiting
John Peter Smith (JPS) Health Network
Fort Worth, Texas, 76104
Maximillian Masuda
James P d'Etienne, MD
- Recruiting
Baylor College of Medicine/Ben Taub
Houston, Texas, 77030
Kelly Keene, 713-873-9818
Zubaid Rafique, MD
- Recruiting
Baylor College of Medicine/St. Luke's Medical Center
Houston, Texas, 77030
Kelly Keene
Zubaid Rafique, MD
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Lucas Lemar, 913-588-3580
Chad Cannon, MD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Hannah Zamore
Danielle Sandsmark, MD
- Recruiting
Carilion Clinic
Roanoke, Virginia, 24014
Daniella Rodriguez, 540-588-3183
Damon R Kuehl, MD
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14620
Kian Merchant-Borna, MPH, MBA
Jeffrey Bazarian, MD
- Recruiting
Stony Brook Medicine
Stony Brook, New York, 11794
Maria Taylor
Adam Singer, MD
About this study
Official title: HEAD Injury Serum Markers and Multi-modalities for Assessing Response to Trauma II
The goal of HeadSMART II (HEAD injury Serum markers and Multi-modalities for Assessing Response to Trauma II) is to develop an In-Vitro Diagnostic, the BRAINBox TBI test, to aid in the diagnosis and prognosis of patients with mild traumatic brain injury, by incorporating blood biomarkers, clinical assessments, and tools to measure associated neurocognitive impairments.
Read the detailed description
This study proposes to collect data using a multi-modality approach including blood biomarkers, clinical assessments, neurocognitive performance, and neuropsychological characteristics, to identify subjects with a mild Traumatic Brain Injury (TBI) and their likelihood of chronic symptoms.
This is an observational study with an expectation of enrolling up to 2000 subjects. These subjects will include the intended use population, subjects presenting to the Emergency Department or Urgent Care with a blunt head trauma. Data will be collected across four time points, T=0, 14 days, 30 days and 90 days, to allow for building and validating the algorithms for both diagnosis and prognosis claims.
Control populations, healthy and trauma only (no head trauma) will be included for assay development. Data will be collected for these groups at T=0 and 14 days (trauma control only).
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- Cognitive Assessment, Patient Reported Neurological Outcome Assessments, Blood Draw
- Keywords
- TBI, mTBI
- Medical subject headings
- Brain Concussion, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive AssessmentBehavioural
Self administered cognitive battery
Patient Reported Neurological Outcome AssessmentsBehavioural
Standard neurocognitive and neuropsychological tests
Blood DrawProcedure or surgery
Specimen collection of whole blood, serum, RNA
| Study group | Role | What they receive |
|---|---|---|
| Target Condition | Subjects presenting to the Emergency Department (ED) or Urgent Care (UC) with a blunt head trauma Receives: Behavioral: Cognitive Assessment; Behavioral: Patient Reported Neurological Outcome Assessments; Procedure: Blood Draw | |
| Trauma Control | Subjects presenting to the ED or UC requiring an Xray but do not have a head trauma Receives: Behavioral: Cognitive Assessment; Behavioral: Patient Reported Neurological Outcome Assessments; Procedure: Blood Draw | |
| Healthy Control | Subjects that are healthy and not taking any prescription medications Receives: Behavioral: Cognitive Assessment; Procedure: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of mild traumatic brain injury diagnosis using the BRAINBox TBI Test compared to the Expert Clinical Diagnosis
Sensitivity and specificity of the diagnosis as compared to a clinical diagnosis by an expert committee
Measured: 30 days
Determine the risk stratification of having symptoms at 14, 30 and 90 days, for subjects with mild traumatic brain injury using the BRAINBox TBI Test results.
Sensitivity and specificity of the risk for chronic symptoms as compared to the post-concussion symptoms at predefined time points
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start31 Dec 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BRAINBox Solutions Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Peacock, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423198
- Sponsor's protocol ID
- CLIN01001
- Acronym
- HeadSMART II
- Status last verified
- May 2021
- First submitted
- 5 Jun 2020
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEAD Injury Serum Markers and Multi-modalities for Assessing Response to Trauma II
- ClinicalTrials.gov ID
- NCT04423198
- Acronym / sponsor ID
- HeadSMART II / CLIN01001
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- TBI, mTBI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- BRAINBox Solutions IncIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 9 Jun 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 goal of HeadSMART II (HEAD injury Serum markers and Multi-modalities for Assessing Response to Trauma II) is to develop an In-Vitro Diagnostic, the BRAINBox TBI test, to aid in the diagnosis and prognosis of patients with mild traumatic brain injury, by incorporating blood biomarkers, clinical assessments, and tools to measure associated neurocognitive impairments.
Detailed description
This study proposes to collect data using a multi-modality approach including blood biomarkers, clinical assessments, neurocognitive performance, and neuropsychological characteristics, to identify subjects with a mild Traumatic Brain Injury (TBI) and their likelihood of chronic symptoms.
This is an observational study with an expectation of enrolling up to 2000 subjects. These subjects will include the intended use population, subjects presenting to the Emergency Department or Urgent Care with a blunt head trauma. Data will be collected across four time points, T=0, 14 days, 30 days and 90 days, to allow for building and validating the algorithms for both diagnosis and prognosis claims.
Control populations, healthy and trauma only (no head trauma) will be included for assay development. Data will be collected for these groups at T=0 and 14 days (trauma control only).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Target Condition | – | Behavioral: Cognitive Assessment, Behavioral: Patient Reported Neurological Outcome Assessments, Procedure: Blood DrawSubjects presenting to the Emergency Department (ED) or Urgent Care (UC) with a blunt head trauma |
| Trauma Control | – | Behavioral: Cognitive Assessment, Behavioral: Patient Reported Neurological Outcome Assessments, Procedure: Blood DrawSubjects presenting to the ED or UC requiring an Xray but do not have a head trauma |
| Healthy Control | – | Behavioral: Cognitive Assessment, Procedure: Blood DrawSubjects that are healthy and not taking any prescription medications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects presenting to the Emergency Department or Urgent Care with a blunt head trauma.
Key inclusion criteria (9 listed)
- Age >=18 years
- Ability to provide a blood sample; within 96 hours of injury
- Ability to provide informed consent. Consent may be obtained with assistance of a legally authorized representative (LAR)
- Must present to the Emergency Department (ED) or Urgent Care (UC) with a blunt head trauma
- Age >=18 years
Key exclusion criteria (26 listed)
- Glasgow Coma Scale (GCS) score < 13, as presented in ED at time of screening
- Need for general anesthesia at the time of presentation in the ED
- Diagnosed dementia requiring assistance for daily living
- Any head trauma requiring medical attention from a physician within the last 6 months
- Received chemotherapy or radiation within the last year
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 |
|---|---|---|
| Cognitive AssessmentSelf administered cognitive battery | Behavioural | Healthy Control, Target Condition, Trauma Control |
| Patient Reported Neurological Outcome AssessmentsStandard neurocognitive and neuropsychological tests | Behavioural | Target Condition, Trauma Control |
| Blood DrawSpecimen collection of whole blood, serum, RNA | Procedure or surgery | Healthy Control, Target Condition, Trauma Control |
Primary outcome
Correlation of mild traumatic brain injury diagnosis using the BRAINBox TBI Test compared to the Expert Clinical Diagnosis
Time frame: 30 days
Sensitivity and specificity of the diagnosis as compared to a clinical diagnosis by an expert committee
Determine the risk stratification of having symptoms at 14, 30 and 90 days, for subjects with mild traumatic brain injury using the BRAINBox TBI Test results.
Time frame: up to 90 days
Sensitivity and specificity of the risk for chronic symptoms as compared to the post-concussion symptoms at predefined time points
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
Frank Peacock, MD principal investigator
Baylor College of Medicine
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 Mild Traumatic Brain Injury, run by BRAINBox Solutions 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 9 inclusion and 26 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 4 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donna Edmonds (804-212-2975, dedmonds@brainboxinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of mild traumatic brain injury diagnosis using the BRAINBox TBI Test compared to the Expert Clinical Diagnosis (time frame: 30 days). The study lists 2 primary outcomes in all. 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 4 Aug 2021.