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

Recruiting

• Conditions: Closed Head Injury; Concussion, Brain; MTBI - Mild Traumatic Brain Injury; TBI (Traumatic Brain Injury)

• Registration Number: NCT04279431
• Lead Sponsor: BrainScope Company, Inc.

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-02-19
• Study First Posted: 2020-02-21
• Study Start: 2020-05-25
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-27
• Primary Completion: 2023-12-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 660

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical utility of integration of BSC SIC into the triage of closed head injured patients.	30 days	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.

Secondary Outcome Measures

Name	Time	Method
To correlate BFI and CI to the severity and duration of concussive symptom burden (measured by CSI)	After enrollment closure	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.
High NPV adds confidence to the clinical decision not to scan when the BrainScope SIC is negative	After enrollment closure	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.
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.	After enrollment closure	Compare accuracy of Nexus II and CCHR Imaging rules to BrainScope in predicting true negatives