HEAD Injury Serum Markers and Multi-modalities for Assessing Response to Trauma

• Conditions: Mild Traumatic Brain Injury
• Interventions: Behavioral: Cognitive Assessment; Procedure: Blood Draw; Behavioral: Patient Reported Neurological Outcome Assessments

• Registration Number: NCT04423198
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-06-05
• Study First Submitted QC: 2020-06-08
• Study First Posted: 2020-06-09
• Study Start: 2020-12-31
• Status Verified: 2021-05
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-04
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Control	Blood Draw	Subjects that are healthy and not taking any prescription medications
Trauma Control	Blood Draw	Subjects presenting to the ED or UC requiring an Xray but do not have a head trauma
Target Condition	Patient Reported Neurological Outcome Assessments	Subjects presenting to the Emergency Department (ED) or Urgent Care (UC) with a blunt head trauma
Trauma Control	Cognitive Assessment	Subjects presenting to the ED or UC requiring an Xray but do not have a head trauma
Target Condition	Cognitive Assessment	Subjects presenting to the Emergency Department (ED) or Urgent Care (UC) with a blunt head trauma
Target Condition	Blood Draw	Subjects presenting to the Emergency Department (ED) or Urgent Care (UC) with a blunt head trauma
Trauma Control	Patient Reported Neurological Outcome Assessments	Subjects presenting to the ED or UC requiring an Xray but do not have a head trauma
Healthy Control	Cognitive Assessment	Subjects that are healthy and not taking any prescription medications

Primary Outcome Measures

Name	Time	Method
Correlation of mild traumatic brain injury diagnosis using the BRAINBox TBI Test compared to the Expert Clinical Diagnosis	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.	up to 90 days	Sensitivity and specificity of the risk for chronic symptoms as compared to the post-concussion symptoms at predefined time points

Trial Locations

Locations (11)

Detroit Receiving; 🇺🇸 Detroit, Michigan, United States

Harper University Hospital; 🇺🇸 Detroit, Michigan, United States

Sinai Grace Hospital; 🇺🇸 Detroit, Michigan, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

John Peter Smith (JPS) Health Network; 🇺🇸 Fort Worth, Texas, United States

Carilion Clinic; 🇺🇸 Roanoke, Virginia, United States

Stony Brook Medicine; 🇺🇸 Stony Brook, New York, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Baylor College of Medicine/Ben Taub; 🇺🇸 Houston, Texas, United States

Baylor College of Medicine/St. Luke's Medical Center; 🇺🇸 Houston, Texas, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States