Follow-up of mTBI Patients Discharged From the ED Using Standard Clinical Triage Including BrainScope One (MEDO)

The purpose of the study is to validate the clinical outcome in patients with closed head injuries (GCS 14-15, ages 18-85) who are being evaluated for head trauma, integrating the BrainScope One structural injury classifier (SIC) algorithm, with focus on SIC negative classification. In addition, to assess functional impairment (concussion) in these patients, results from Brain Function Index (BFI) or Concussion Index (CI) algorithms will be used for analysis.

Study Overview

• Status: Recruiting
• Conditions: TBI (Traumatic Brain Injury); Concussion, Brain; MTBI - Mild Traumatic Brain Injury; Closed Head Injury
• Intervention / Treatment: Device: EEG Recording; Other: Neurocognitive Tests; Other: Clinician Evaluation; Other: 22-item CSI

Detailed Description

BrainScope One incorporates brain electrical activity (EEG, a proven electrophysiological core technology) and other multimodal assessment capabilities in a portable, point-of-care, non-invasive device containing algorithms designed to improve early identification, staging, and optimization of treatment for head injured patients (GCS 13-15) who are suspected of a brain injury. Structural Injury Classifier (SIC) provides objective results that indicate the likelihood of a structural brain injury being present, potentially visible on CT Scan. Brain Function Index (BFI) provides an objective measurement to determine the likelihood and severity of brain function impairment such as that seen in concussion/mTBI. The BFI is presented as a percentile compared to a normal corresponding population. Lastly, the Concussion Index (CI) was derived in the most recent BrainScope concussion assessment clinical study, and it is defined as a multivariate, multimodal index to assess the presence and severity of concussion and has been demonstrated to reliably reflect change over time.

The present study population targets those patients who sustained a head injury, have high GCS scores (14-15) and present mild symptoms, for whom the suspicion of structural brain injury is therefore low. Having a rapid, reliable, and sensitive assessment tool to aid in the triage of patients who are suspected of a traumatically induced structural brain injury could aid in appropriate and timely diagnosis and subsequent medical care. It may also result in more appropriate utilization of medical imaging (potentially having associated health risks) and reductions in hospitalizations. Patients discharged from the ED who were deemed to not require a CT scan will be followed-up for outcome.

• Study Type: Observational
• Enrollment (Estimated): 660

Contacts and Locations

• Study Contact: Name: Saloni Kanakia, MS; Phone Number: 1042 240-752-7680; Email: saloni.kanakia@brainscope.com
• Study Contact Backup: Name: Brian O'Neil, MD; Phone Number: 313-993-2530; Email: boneil@med.wayne.edu

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Health System
      • Principal Investigator: Joseph Miller, MD
      • Contact: Joseph Miller, MD; Phone Number: 800-653-6568; Email: JMILLER6@hfhs.org
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Wayne State University - Detroit Receiving Hospital
      • Contact: Brian O'Neil, MD; Phone Number: 313-745-9269; Email: boneil@med.wayne.edu
      • Principal Investigator: Brian O'Neil, MD
    • Detroit, Michigan, United States, 48235
      • Recruiting
      • Wayne State University - Sinai Grace Hospital
      • Contact: Brian O'Neil, MD; Phone Number: 313-745-9269; Email: boneil@med.wayne.edu
      • Principal Investigator: Brian J O'Neil, MD
    • Royal Oak, Michigan, United States, 48073
      • Terminated
      • Beaumont Hospital
    • Troy, Michigan, United States, 48085
      • Terminated
      • Beaumont Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University - Barnes Jewish Hospital
      • Contact: Rosanne Naunheim, MD; Phone Number: 314-758-6787; Email: naunheir@wustl.edu
      • Principal Investigator: Rosanne Naunheim, MD
  • Texas
    • El Paso, Texas, United States, 79905
      • Recruiting
      • El Paso Medical Center
      • Principal Investigator: Edward Michelson, MD
      • Contact: Edward Michelson, MD; Phone Number: 915-215-4609; Email: Edward.Michelson@ttuhsc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

An estimated total of 660 patients (with target of 330 SIC negative patients) who are suspected of a traumatic, closed head injury within 3 days of injury, will be recruited from patients who enter the participating Hospital ED's as clinical sites for this study. Potential study subjects will be identified by the research staff based on the stated inclusion and exclusion criteria to determine their eligibility. Once identified, the research staff will recruit the subject for the study through an informed consent process. Participation in the study will not interfere with standard of care at the clinical sites.

Description

• Inclusion Criteria:

  1. Patient can be of any gender;
  2. Patient must be admitted to the ED with a traumatic closed head injury within 72 hours of injury;
  3. Patient's Age must be ≥18 and <86 years old at time of enrollment;
  4. Patient must be Glasgow Coma Scale (GCS) 14-15 at time of BrainScope evaluation (even if GCS was lower prior to arrival e.g. at time of injury).

• Exclusion Criteria:

  1. Patients with forehead, scalp, earlobe or skull abnormalities or other conditions that would prevent correct application of the electrode headset;
  2. Patients with Dementia, Parkinson's Disease, Multiple Sclerosis, brain tumors, history of brain surgery, evidence of acute psychosis or history of stroke with neurological deficit within the last year;
  3. Patients on anti-platelets, anti-coagulants, other than aspirin, currently receiving dialysis or in end-stage renal disease or current condition is "critical" in the opinion of the investigator;
  4. Patients with active fever defined as greater than 100oF or 37.7oC;
  5. Patients suffering from an open head injury or have suffered multi-trauma which requires hospitalization (for injuries not related to the head injury)
  6. Patients requiring advanced airway management (i.e. mechanical ventilation);
  7. Patients currently receiving procedural sedation medications (e.g. benzodiazepine, anesthetic, NMDA receptor antagonist, or opioid agonist) Note: patient can be enrolled when they are no longer obtunded and have the capacity to consent;
  8. Pregnant women and prisoners;
  9. Patients who have had a Head CT scan for current traumatic injury event prior to screening.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SIC Negative; Subjects will include males and females ranging from ages 18 to 85 who are admitted to the ED with a traumatic, closed head injury within 3 days of injury. Subject will undergo site standard clinical ED evaluation and a BrainScope evaluation. The SIC negative group are those patients who obtain a 'Negative' result on the BrainScope One Structural Injury Classifier (SIC) algorithm.	Device: EEG Recording; EEG recording acquired on BrainScope One device.; Other: Neurocognitive Tests; Cognitive performance tests performed on BrainScope One device.; Other: Clinician Evaluation; Clinician evaluation performed as part of standard of care at the clinical site.; Other: 22-item CSI; Self assessed 22-item Concussion Symptom Inventory (CSI).
SIC Positive/Equivocal; Subjects will include males and females ranging from ages 18 to 85 who are admitted to the ED with a traumatic, closed head injury within 3 days of injury. Subject will undergo site standard clinical ED evaluation and a BrainScope evaluation. The SIC positive group are those patients who obtain a 'Positive' or 'Equivocal' result on the BrainScope One SIC algorithm.	Device: EEG Recording; EEG recording acquired on BrainScope One device.; Other: Neurocognitive Tests; Cognitive performance tests performed on BrainScope One device.; Other: Clinician Evaluation; Clinician evaluation performed as part of standard of care at the clinical site.; Other: 22-item CSI; Self assessed 22-item Concussion Symptom Inventory (CSI).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical utility of integration of BSC SIC into the triage of closed head injured patients.	Demonstrate the accuracy of the BrainScope Structural Injury Classifier (SIC) negative findings through repeated follow ups of those patients discharged from the ED without receiving a CT scan, as determined by the ED physician.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High NPV adds confidence to the clinical decision not to scan when the BrainScope SIC is negative	For those who were BSC SIC negative and who are referred to CT due to clinician's decision, CT results will be obtained to assess the accuracy of BrainScope finding, this will allow an estimate of NPV.	After enrollment closure
Higher specificity in BSC SIC compared to Nexus II and CCHR could result in decrease of referral for unnecessary CT scans due to higher specificity.	Compare accuracy of Nexus II and CCHR Imaging rules to BrainScope in predicting true negatives	After enrollment closure
To correlate BFI and CI to the severity and duration of concussive symptom burden (measured by CSI)	The BFI/CI can help to inform the clinical decision on the likely of concussion at the time of injury in the ED environment and predict prolonged recovery.	After enrollment closure

Collaborators and Investigators

• Sponsor: BrainScope Company, Inc.
• Investigators: Study Director: Leslie S Prichep, Ph.D., BrainScope Company, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2020
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: mTBI; Concussion; Closed Head Injury; BrainScope; EEG Evaluation; Cognitive Evaluation; Concussion Symptom Inventory
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds, Nonpenetrating; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Craniocerebral Trauma; Brain Concussion; Head Injuries, Closed
• Other Study ID Numbers: 40

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes