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

Mild Traumatic Brain Injury Clinical Trial

— HeadSMART II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04423198
• Other study ID #: CLIN01001
• Status: Recruiting
• Start date: December 31, 2020
• Est. completion date: December 2021

Study information

• Verified date: May 2021
• Source: BRAINBox Solutions Inc
• Contact: Donna Edmonds
• Phone: 804-212-2975
• Email: dedmonds[@]brainboxinc.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 tools to measure associated neurocognitive impairments.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Craniocerebral Trauma
• Mild Traumatic Brain Injury
• Wounds and Injuries

Intervention

Behavioral:
• Cognitive Assessment
Self administered cognitive battery
• Patient Reported Neurological Outcome Assessments
Standard neurocognitive and neuropsychological tests

Procedure:
• Blood Draw
Specimen collection of whole blood, serum, RNA

Locations

Country	Name	City	State
United States	Detroit Receiving	Detroit	Michigan
United States	Harper University Hospital	Detroit	Michigan
United States	Sinai Grace Hospital	Detroit	Michigan
United States	John Peter Smith (JPS) Health Network	Fort Worth	Texas
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	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Carilion Clinic	Roanoke	Virginia
United States	University of Rochester Medical Center	Rochester	New York
United States	Stony Brook Medicine	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
BRAINBox Solutions Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days
Primary	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	up to 90 days