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

Sponsor
BRAINBox Solutions Inc (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04423198
Collaborator
(none)
2,000
Enrollment
11
Locations
11
Anticipated Duration (Months)
181.8
Patients Per Site
16.5
Patients Per Site Per Month

Study Details

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 Phase
  • 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
Anticipated 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 :
Dec 31, 2020
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm 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 [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. [up to 90 days]

    Sensitivity and specificity of the risk for chronic symptoms as compared to the post-concussion symptoms at predefined time points

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Locations

Site City State Country Postal Code
1 University of Kansas Medical Center Kansas City Kansas United States 66160
2 Detroit Receiving Detroit Michigan United States 48201
3 Harper University Hospital Detroit Michigan United States 48201
4 Sinai Grace Hospital Detroit Michigan United States 48235
5 University of Rochester Medical Center Rochester New York United States 14620
6 Stony Brook Medicine Stony Brook New York United States 11794
7 University of Pennsylvania Philadelphia Pennsylvania United States 19104
8 John Peter Smith (JPS) Health Network Fort Worth Texas United States 76104
9 Baylor College of Medicine/Ben Taub Houston Texas United States 77030
10 Baylor College of Medicine/St. Luke's Medical Center Houston Texas United States 77030
11 Carilion Clinic Roanoke Virginia United States 24014

Sponsors and Collaborators

  • BRAINBox Solutions Inc

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
BRAINBox Solutions Inc
ClinicalTrials.gov Identifier:
NCT04423198
Other Study ID Numbers:
  • CLIN01001
First Posted:
Jun 9, 2020
Last Update Posted:
Aug 4, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
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

Study Results

No Results Posted as of Aug 4, 2021