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

NCT04279431 | Active Not Recruiting FDA Device

• 1 other identifier: MEDO-40
• Study Type: observational
• Target: 660
• Locations: 1 country
• Sites: 7

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.

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

Outcome Measures

Primary Outcomes (1)

• Clinical utility of integration of BSC SIC into the triage of closed head injured patients.

  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.

  30 days

Secondary Outcomes (3)

• High NPV adds confidence to the clinical decision not to scan when the BrainScope SIC is negative

  After enrollment closure

• 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

• To correlate BFI and CI to the severity and duration of concussive symptom burden (measured by CSI)

  After enrollment closure

Study Arms (2)

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.

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

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

Interventions

EEG Recording DEVICE

EEG recording acquired on BrainScope One device.

SIC Negative; SIC Positive/Equivocal

Neurocognitive Tests OTHER

Cognitive performance tests performed on BrainScope One device.

SIC Negative; SIC Positive/Equivocal

Clinician Evaluation OTHER

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

SIC Negative; SIC Positive/Equivocal

22-item CSI OTHER

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

SIC Negative; SIC Positive/Equivocal

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient can be of any gender;
• Patient must be admitted to the ED with a traumatic closed head injury within 72 hours of injury;
• Patient's Age must be ≥18 and \<86 years old at time of enrollment;
• 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).

You may not qualify if:

• Patients with forehead, scalp, earlobe or skull abnormalities or other conditions that would prevent correct application of the electrode headset;
• 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;
• 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;
• Patients with active fever defined as greater than 100oF or 37.7oC;
• Patients suffering from an open head injury or have suffered multi-trauma which requires hospitalization (for injuries not related to the head injury)
• Patients requiring advanced airway management (i.e. mechanical ventilation);
• 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;
• Pregnant women and prisoners;
• Patients who have had a Head CT scan for current traumatic injury event prior to screening.

Sponsors & Collaborators

• BrainScope Company, Inc.: lead

Study Sites (7)

Wayne State University - Detroit Receiving Hospital

Detroit, Michigan, 48201, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Wayne State University - Sinai Grace Hospital

Detroit, Michigan, 48235, United States

Location

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Beaumont Hospital

Troy, Michigan, 48085, United States

Location

Washington University - Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

El Paso Medical Center

El Paso, Texas, 79905, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion; Head Injuries, Closed

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Leslie S Prichep, Ph.D.

  BrainScope Company, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 21, 2020
• Study Start: May 25, 2020
• Primary Completion: September 1, 2024
• Study Completion: September 30, 2024
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)