Validation Of TBI Detection System For Head Injured Patients (B-AHEAD III)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02367300 |
Recruitment Status :
Completed
First Posted : February 20, 2015
Last Update Posted : June 21, 2016
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Condition or disease | Intervention/treatment |
---|---|
Brain Injuries | Device: BrainScope Ahead 200 |
Study Type : | Observational |
Actual Enrollment : | 981 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Validation Of Point-Of-Care TBI Detection System For Head Injured Patients |
Study Start Date : | February 2015 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | January 2016 |
- Device: BrainScope Ahead 200
A single-use, proprietary headset containing pre-gelled electrodes will be placed on the subject's forehead according to the standard locations of the modified International 10/20 system. Subjects will undergo approximately 5 minutes of eyes closed brain electrical activity recording.
- The primary objective of this study is to validate the clinical utility of the BrainScope Ahead 300 device for the acute identification of structural brain injuries in the TBI population, following closed head injury. [ Time Frame: 30 days ]The co-primary endpoints for this study are the sensitivity/specificity pair for CT+ identified by the Ahead 300 algorithm classification.
- To demonstrate the utility of the EEG normality indicator (NI) score from a given subject presented as a percentile of the normal population and an indicator score. [ Time Frame: 30 days ]
- To evaluate the utility of creating a three-tier system for CT+ (CT-, Equivocal Zone (require close observation), and CT+). [ Time Frame: 30 days ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Subjects who are admitted to the ED and are suspected of a traumatic, closed head injury within 72 hours. The patient will have a GCS 12-15 upon arrival to the ED even if GCS was lower prior to arrival to the ED (e.g., at the time of injury).
Exclusion Criteria:
- Subjects will be excluded who have forehead, scalp, or skull abnormalities or other conditions that would prevent correct application of the electrode headset on the skin.
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In addition,
- subjects with dementia,
- Parkinson's Disease,
- multiple sclerosis,
- seizure disorder,
- brain tumors,
- history of brain surgery,
- evidence of acute psychosis,
- substance dependence,
- history of TIA or stroke within the last year,
- currently receiving dialysis or in end-stage renal disease,
- active fever defined as greater than 100 degrees F or 37.7 degrees C,
- current condition is "critical" in the opinion of the investigator,
- subject is suffering from an open head injury,
- subject requires advanced airway management (i.e. mechanical ventilation),
- currently receiving procedural sedation medications.
- Subjects below the age of 18 years, and prisoners will not be eligible for study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02367300
United States, Connecticut | |
Hartford Hospital | |
Hartford, Connecticut, United States, 06102 | |
United States, Georgia | |
Emory University- Grady Hospital | |
Atlanta, Georgia, United States, 30303 | |
United States, Maryland | |
R Cowley Shock Trauma Hospital | |
Baltimore, Maryland, United States, 21201 | |
United States, Michigan | |
Wayne State University - Detroit Receiving Hospital | |
Detroit, Michigan, United States, 48235 | |
Wayne State University - Sinai Grace Hospital | |
Detroit, Michigan, United States, 48235 | |
United States, Missouri | |
Washington University - Barnes Jewish Hospital | |
St. Louis, Missouri, United States, 63110 | |
United States, New York | |
University of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
United States, Pennsylvania | |
Allegheny General Hospital | |
Pittsburgh, Pennsylvania, United States, 15212 | |
United States, Texas | |
Baylor University Medical Center | |
Dallas, Texas, United States, 75246 | |
UT-Houston Health Science Center | |
Houston, Texas, United States, 77030 | |
United States, Virginia | |
University of Virginia Medical Center | |
Charlottesville, Virginia, United States, 22908 |
Principal Investigator: | Douglas C Oberly | BrainScope Company, Inc. |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | BrainScope Company, Inc. |
ClinicalTrials.gov Identifier: | NCT02367300 |
Other Study ID Numbers: |
22-Ahead |
First Posted: | February 20, 2015 Key Record Dates |
Last Update Posted: | June 21, 2016 |
Last Verified: | June 2016 |
Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |