NCT04279431

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 660 (estimated)
• Sponsor: BrainScope Company, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2020-05-25
• Primary completion: 2024-09-01
• Completion: 2024-09-30
• First posted: 2020-02-21
• Last updated: 2024-09-03

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study