Follow-up of MTBI Patients Discharged from the ED Using Standard Clinical Triage Including BrainScope One

NCT ID: NCT04279431

Last Updated: 2024-09-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 660 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-25
• Study Completion Date: 2024-09-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

EEG Recording

Intervention Type: DEVICE

EEG recording acquired on BrainScope One device.

Neurocognitive Tests

Intervention Type: OTHER

Cognitive performance tests performed on BrainScope One device.

Clinician Evaluation

Intervention Type: OTHER

Clinician evaluation performed as part of standard of care at the clinical site.

22-item CSI

Intervention Type: OTHER

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.

EEG Recording

Intervention Type: DEVICE

EEG recording acquired on BrainScope One device.

Neurocognitive Tests

Intervention Type: OTHER

Cognitive performance tests performed on BrainScope One device.

Clinician Evaluation

Intervention Type: OTHER

Clinician evaluation performed as part of standard of care at the clinical site.

22-item CSI

Intervention Type: OTHER

Self assessed 22-item Concussion Symptom Inventory (CSI).

Interventions

EEG Recording

EEG recording acquired on BrainScope One device.

Intervention Type: DEVICE

Neurocognitive Tests

Cognitive performance tests performed on BrainScope One device.

Intervention Type: OTHER

Clinician Evaluation

Clinician evaluation performed as part of standard of care at the clinical site.

Intervention Type: OTHER

22-item CSI

Self assessed 22-item Concussion Symptom Inventory (CSI).

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BrainScope Company, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leslie S Prichep, Ph.D.

Role: STUDY_DIRECTOR

BrainScope Company, Inc.

Locations

Wayne State University - Detroit Receiving Hospital

Detroit, Michigan, United States

Henry Ford Health System

Detroit, Michigan, United States

Wayne State University - Sinai Grace Hospital

Detroit, Michigan, United States

Beaumont Hospital

Royal Oak, Michigan, United States

Beaumont Hospital

Troy, Michigan, United States

Washington University - Barnes Jewish Hospital

St Louis, Missouri, United States

El Paso Medical Center

El Paso, Texas, United States

Countries

United States

Other Identifiers

MEDO-40

Identifier Type: -

Identifier Source: org_study_id