Concussion, Brain Clinical Trial
— MEDOOfficial title:
Follow-up of mTBI Patients Discharged From the ED Using Standard Clinical Triage Including BrainScope One
NCT number | NCT04279431 |
Other study ID # | 40 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 25, 2020 |
Est. completion date | March 31, 2024 |
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.
Status | Recruiting |
Enrollment | 660 |
Est. completion date | March 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Henry Ford Health System | Detroit | Michigan |
United States | Wayne State University - Detroit Receiving Hospital | Detroit | Michigan |
United States | Wayne State University - Sinai Grace Hospital | Detroit | Michigan |
United States | El Paso Medical Center | El Paso | Texas |
United States | Beaumont Hospital | Royal Oak | Michigan |
United States | Washington University - Barnes Jewish Hospital | Saint Louis | Missouri |
United States | Beaumont Hospital | Troy | Michigan |
Lead Sponsor | Collaborator |
---|---|
BrainScope Company, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | High NPV adds confidence to the clinical decision not to scan when the BrainScope SIC is negative | For those who were BSC SIC negative and who are referred to CT due to clinician's decision, CT results will be obtained to assess the accuracy of BrainScope finding, this will allow an estimate of NPV. | After enrollment closure | |
Secondary | 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. | Compare accuracy of Nexus II and CCHR Imaging rules to BrainScope in predicting true negatives | After enrollment closure | |
Secondary | To correlate BFI and CI to the severity and duration of concussive symptom burden (measured by CSI) | The BFI/CI can help to inform the clinical decision on the likely of concussion at the time of injury in the ED environment and predict prolonged recovery. | After enrollment closure |
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