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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 : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
BRAINBox Solutions Inc

Brief 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 tools to measure associated neurocognitive impairments.

Condition or disease Intervention/treatment
Mild Traumatic Brain Injury Behavioral: Cognitive Assessment Behavioral: Patient Reported Neurological Outcome Assessments Procedure: Blood Draw

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).

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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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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

  2. 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:

  1. Serum
  2. RNA
  3. Whole blood


Information from the National Library of Medicine

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.


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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
Study Population
Subjects presenting to the Emergency Department or Urgent Care with a blunt head trauma.
Criteria

Target Condition Subjects

Inclusion Criteria:

  1. Age >=18 years
  2. Ability to provide a blood sample; within 96 hours of injury
  3. Ability to provide informed consent. Consent may be obtained with assistance of a legally authorized representative (LAR)
  4. Must present to the Emergency Department (ED) or Urgent Care (UC) with a blunt head trauma

Exclusion Criteria:

  1. Glasgow Coma Scale (GCS) score < 13, as presented in ED at time of screening
  2. Need for general anesthesia at the time of presentation in the ED
  3. Diagnosed dementia requiring assistance for daily living
  4. Any head trauma requiring medical attention from a physician within the last 6 months
  5. Received chemotherapy or radiation within the last year
  6. History of stroke with disabling outcomes, brain tumor, epilepsy or intracranial surgery/hemorrhage
  7. Psychiatric hospitalization in the last 90 days
  8. Blood transfusion within the prior 4 weeks
  9. Non-working telephone number
  10. Current participant in an interventional clinical trial
  11. Cannot perform study tasks on an iPad (e.g. not wearing corrective lenses necessary to read, inability to use both hands)
  12. Subject considered unsuitable for participation in this clinical trial by PI, treating clinician or research study staff

Control Subjects

Inclusion:

  1. Age >=18 years
  2. Ability to provide a blood sample; (For Trauma Controls (TC's) within 96 hours of injury)
  3. Ability to provide informed consent. (For TC's consent may be obtained with assistance of a legally authorized representative (LAR)
  4. Presents to the Emergency Department or Urgent Care with at least one injury requiring an X-Ray (TC's only)
  5. Healthy and not taking prescription medications (Healthy Controls (HC's) only)

Exclusion:

  1. Head trauma or symptoms with head trauma at presentation
  2. Head trauma requiring medical attention from a physician within the last 6 months
  3. Internal organ injury (e.g. liver laceration, pulmonary contusion, spinal cord injury) that requires inpatient hospitalization
  4. Need for general anesthesia at the time of presentation in the ED
  5. Diagnosed dementia requiring assistance for daily living
  6. Received chemotherapy or radiation within the last year
  7. History of stroke with disabling outcomes, brain tumor, epilepsy or intracranial surgery/hemorrhage
  8. Psychiatric hospitalization in the last 90 days
  9. Blood transfusion within the prior 4 weeks
  10. Non-working telephone number
  11. Current participant in an interventional clinical trial
  12. Cannot perform study tasks on an iPad (e.g. not wearing corrective lenses necessary to read, inability to use both hands)
  13. Subject considered unsuitable for participation in this clinical trial by PI, treating clinician or research study staff

Information from the National Library of Medicine

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


Contacts
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Contact: Donna Edmonds 804-212-2975 dedmonds@brainboxinc.com
Contact: Andrea Brown, MS 408-881-2611 abrown@brainboxinc.com

Locations
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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         
Sponsors and Collaborators
BRAINBox Solutions Inc
Investigators
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Principal Investigator: Frank Peacock, MD Baylor College of Medicine
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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: January 6, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BRAINBox Solutions Inc:
TBI, mTBI
Additional relevant MeSH terms:
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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