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

BrainScope Company

Status: Active, not recruiting

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

Treatments: Other: Clinician Evaluation; Other: 22-item CSI; Device: EEG Recording; Other: Neurocognitive Tests

Study type: Observational

Funder types: Industry

Identifiers

NCT04279431

MEDO-40

Details and patient eligibility

About

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.

Full 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.

Enrollment: 660 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

660 participants in 2 patient groups

SIC Negative

Description:

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.

Treatment:

Other: 22-item CSI

Other: Clinician Evaluation

Device: EEG Recording

Other: Neurocognitive Tests

SIC Positive/Equivocal

Description:

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.

Treatment:

Other: 22-item CSI

Other: Clinician Evaluation

Device: EEG Recording

Other: Neurocognitive Tests