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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mild Traumatic Brain Injury
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Donna Edmonds; Phone Number: 804-212-2975; Email: dedmonds@brainboxinc.com
• Study Contact Backup: Name: Andrea Brown, MS; Phone Number: 408-881-2611; Email: abrown@brainboxinc.com

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Contact: Lucas Lemar; Phone Number: 913-588-3580
      • Principal Investigator: Chad Cannon, MD
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Harper University Hospital
      • Contact: Justin Sabol
      • Principal Investigator: Robert Welch, MD
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Detroit Receiving
      • Contact: Justin Sabol
      • Principal Investigator: Robert Welch, MD
    • Detroit, Michigan, United States, 48235
      • Recruiting
      • Sinai Grace Hospital
      • Contact: Justin Sabol
      • Principal Investigator: Robert Welch, MD
  • New York
    • Rochester, New York, United States, 14620
      • Recruiting
      • University of Rochester Medical Center
      • Contact: Kian Merchant-Borna, MPH, MBA
      • Principal Investigator: Jeffrey Bazarian, MD
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook Medicine
      • Principal Investigator: Adam Singer, MD
      • Contact: Maria Taylor
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Hannah Zamore
      • Principal Investigator: Danielle Sandsmark, MD
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Recruiting
      • John Peter Smith (JPS) Health Network
      • Contact: Maximillian Masuda
      • Principal Investigator: James P d'Etienne, MD
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine/Ben Taub
      • Contact: Kelly Keene; Phone Number: 713-873-9818
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine/St. Luke's Medical Center
      • Contact: Kelly Keene
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Recruiting
      • Carilion Clinic
      • Contact: Daniella Rodriguez; Phone Number: 540-588-3183
      • Principal Investigator: Damon R Kuehl, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: BRAINBox Solutions Inc
• Investigators: Principal Investigator: Frank Peacock, MD, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: TBI, mTBI
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Craniocerebral Trauma; Brain Concussion
• Other Study ID Numbers: CLIN01001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No