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

• ClinicalTrials.gov Identifier: NCT04423198
• Recruitment Status: Recruiting
• First Posted: June 9, 2020
• Last Update Posted: January 6, 2021
• Sponsor: BRAINBox Solutions Inc
• Information provided by (Responsible Party): BRAINBox Solutions Inc

Study Description

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).

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Donna Edmonds; 804-212-2975; dedmonds@brainboxinc.com

Contact: Andrea Brown, MS; 408-881-2611; abrown@brainboxinc.com

Locations

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

• Principal Investigator: Frank Peacock, MD; Baylor College of Medicine

More Information

• Responsible Party: BRAINBox Solutions Inc
• ClinicalTrials.gov Identifier: NCT04423198
• Other Study ID Numbers: CLIN01001
• First Posted: June 9, 2020
• Last Update Posted: January 6, 2021
• Last Verified: January 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

Keywords provided by BRAINBox Solutions Inc:

TBI, mTBI

Additional relevant MeSH terms:

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