HEAD Injury Serum Markers and Multi-modalities for Assessing Response to Trauma (HeadSMART II)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04423198 |
Recruitment Status :
Recruiting
First Posted : June 9, 2020
Last Update Posted : August 4, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Mild Traumatic Brain Injury | Behavioral: Cognitive Assessment Behavioral: Patient Reported Neurological Outcome Assessments Procedure: Blood Draw |
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 Type : | Observational |
Estimated Enrollment : | 2000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | HEAD Injury Serum Markers and Multi-modalities for Assessing Response to Trauma II |
Actual Study Start Date : | December 31, 2020 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 2021 |

Group/Cohort | Intervention/treatment |
---|---|
Target Condition
Subjects presenting to the Emergency Department (ED) or Urgent Care (UC) with a blunt head trauma
|
Behavioral: Cognitive Assessment
Self administered cognitive battery Behavioral: Patient Reported Neurological Outcome Assessments Standard neurocognitive and neuropsychological tests Procedure: Blood Draw Specimen collection of whole blood, serum, RNA |
Trauma Control
Subjects presenting to the ED or UC requiring an Xray but do not have a head trauma
|
Behavioral: Cognitive Assessment
Self administered cognitive battery Behavioral: Patient Reported Neurological Outcome Assessments Standard neurocognitive and neuropsychological tests Procedure: Blood Draw Specimen collection of whole blood, serum, RNA |
Healthy Control
Subjects that are healthy and not taking any prescription medications
|
Behavioral: Cognitive Assessment
Self administered cognitive battery Procedure: Blood Draw Specimen collection of whole blood, serum, RNA |
- 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
Biospecimen Retention: Samples With DNA
Specimen Samples for the analysis of biomarkers include:
- Serum
- RNA
- Whole blood

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Target Condition Subjects
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Inclusion:
- Age >=18 years
- Ability to provide a blood sample; (For Trauma Controls (TC's) within 96 hours of injury)
- 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)
Exclusion:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04423198
Contact: Donna Edmonds | 804-212-2975 | dedmonds@brainboxinc.com | |
Contact: Andrea Brown, MS | 408-881-2611 | abrown@brainboxinc.com |
United States, Kansas | |
University of Kansas Medical Center | Recruiting |
Kansas City, Kansas, United States, 66160 | |
Contact: Lucas Lemar 913-588-3580 | |
Principal Investigator: Chad Cannon, MD | |
United States, Michigan | |
Detroit Receiving | Recruiting |
Detroit, Michigan, United States, 48201 | |
Contact: Justin Sabol | |
Principal Investigator: Robert Welch, MD | |
Harper University Hospital | Recruiting |
Detroit, Michigan, United States, 48201 | |
Contact: Justin Sabol | |
Principal Investigator: Robert Welch, MD | |
Sinai Grace Hospital | Recruiting |
Detroit, Michigan, United States, 48235 | |
Contact: Justin Sabol | |
Principal Investigator: Robert Welch, MD | |
United States, New York | |
University of Rochester Medical Center | Recruiting |
Rochester, New York, United States, 14620 | |
Contact: Kian Merchant-Borna, MPH, MBA | |
Principal Investigator: Jeffrey Bazarian, MD | |
Stony Brook Medicine | Recruiting |
Stony Brook, New York, United States, 11794 | |
Contact: Maria Taylor | |
Principal Investigator: Adam Singer, MD | |
United States, Pennsylvania | |
University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Hannah Zamore | |
Principal Investigator: Danielle Sandsmark, MD | |
United States, Texas | |
John Peter Smith (JPS) Health Network | Recruiting |
Fort Worth, Texas, United States, 76104 | |
Contact: Maximillian Masuda | |
Principal Investigator: James P d'Etienne, MD | |
Baylor College of Medicine/Ben Taub | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Kelly Keene 713-873-9818 | |
Principal Investigator: Zubaid Rafique, MD | |
Baylor College of Medicine/St. Luke's Medical Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Kelly Keene | |
Principal Investigator: Zubaid Rafique, MD | |
United States, Virginia | |
Carilion Clinic | Recruiting |
Roanoke, Virginia, United States, 24014 | |
Contact: Daniella Rodriguez 540-588-3183 | |
Principal Investigator: Damon R Kuehl, MD |
Principal Investigator: | Frank Peacock, MD | Baylor College of Medicine |
Responsible Party: | BRAINBox Solutions Inc |
ClinicalTrials.gov Identifier: | NCT04423198 |
Other Study ID Numbers: |
CLIN01001 |
First Posted: | June 9, 2020 Key Record Dates |
Last Update Posted: | August 4, 2021 |
Last Verified: | May 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
TBI, mTBI |
Brain Injuries Brain Injuries, Traumatic Brain Concussion Craniocerebral Trauma Wounds and Injuries Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Head Injuries, Closed Wounds, Nonpenetrating |