Clinical trial NCT04279431: Follow-up of MTBI Patients Discharged from the ED Using Standard Clinical Triage Including BrainScope One
Official title: Follow-up of MTBI Patients Discharged from the ED Using Standard Clinical Triage Including BrainScope One
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: TBI (Traumatic Brain Injury)
Concussion, Brain
MTBI - Mild Traumatic Brain Injury
Closed Head Injury
Keywords: BrainScope
Closed Head Injury
Concussion
EEG Evaluation
Cognitive Evaluation
Concussion Symptom Inventory
mTBI
Lead sponsor: BrainScope Company, Inc.
Sponsor class: INDUSTRY
First posted: 2020-02-21
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Clinical utility of integration of BSC SIC into the triage of closed head injured patients.
timeFrame: 30 days
Secondary outcomes:
measure: High NPV adds confidence to the clinical decision not to scan when the BrainScope SIC is negative
timeFrame: After enrollment closure
measure: 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.
timeFrame: After enrollment closure
measure: To correlate BFI and CI to the severity and duration of concussive symptom burden (measured by CSI)
timeFrame: After enrollment closure
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University - Detroit Receiving Hospital
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Detroit
country: United States
facility: Wayne State University - Sinai Grace Hospital
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Hospital
state: Michigan
city: Troy
country: United States
facility: Beaumont Hospital
state: Michigan
city: St. Louis
country: United States
facility: Washington University - Barnes Jewish Hospital
state: Missouri
city: El Paso
country: United States
facility: El Paso Medical Center
state: Texas
Study officials:
affiliation: BrainScope Company, Inc.
name: Leslie S Prichep, Ph.D.
role: STUDY_DIRECTOR
References: