Deployment of a Novel National Institute of Neurological Disorders and Stroke Clinical, Biomarker, Imaging, and Modifiers (CBI-M) Classification Framework for Emergency Department Patients With Glasgow Coma Scale 15 Traumatic Brain Injury (PIONEER-Prognosis)
Traumatic Brain Injury
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- 18 years - 65 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 500 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
This study is being done to learn how information from blood tests, medical records, and wearable devices that track sleep, activity, and heart rate can help predict how people recover after a concussion. The goal is to improve how doctors monitor recovery and give patients better information about what to expect after a head injury.
Read the full description
The PIONEER-Prognosis Study is a prospective, multicenter, observational cohort study of adults aged 18 to 65 years who present to the emergency department (ED) within 24 hours of a mild traumatic brain injury (TBI) and have a Glasgow Coma Scale (GCS) score of 15, meaning they are fully alert. Although these injuries are classified as mild, up to half of such patients report persistent symptoms such as headaches, cognitive difficulties, and mood disturbances a year after injury, and clinicians currently lack a reliable way to predict, at the time of the ED visit, which patients will recover fully and which will not.
This study will apply a new classification framework proposed by the National Institute of Neurological Disorders and Stroke (NINDS), called Clinical, Biomarker, Imaging, and Modifiers (CBI-M). This framework combines clinical findings; blood tests for two brain injury proteins, glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1); results of any head computed tomography (CT) scan performed as part of routine care; and psychosocial and environmental factors. The study will evaluate how well this framework predicts recovery.
A total of 500 participants will be enrolled from five EDs in Michigan, Oregon, and California that already use GFAP and UCH-L1 blood tests in clinical care. Participants will provide a blood sample and clinical information during their ED visit, wear a WHOOP wearable device continuously for 90 days to record heart rate, heart rate variability, sleep, and physical activity, complete a brief daily symptom survey through the device application, and complete additional symptom and sleep questionnaires by email or phone at 1 week, 1 month, and 2 months.
Trained interviewers from a central outcomes team will contact participants by telephone at 14 and 90 days to assess functional recovery using the Glasgow Outcome Scale-Extended (GOS-E), along with symptoms, cognition, life satisfaction, post-traumatic stress symptoms, and resilience.
The primary outcome is complete functional recovery, defined as a GOS-E score of 8 at 90 days. The study does not assign any treatment; participants receive standard ED care. Findings are intended to improve prognostic accuracy, patient counseling, and follow-up care for the largest subgroup of patients with TBI. The prediction models developed will be made available as a free web-based tool. The study is funded by the U.S. Department of Defense and is expected to take approximately 4 years to complete, with each participant followed for 3 months.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- Diagnosis of mild traumatic brain injury (TBI), as defined by the 2023 American Congress of Rehabilitation Medicine (ACRM) criteria.
- Enrollment within 24 hours of injury.
- Glasgow Coma Scale (GCS) score of 15 at emergency department (ED) enrollment.
- Consent to study procedures, including:
- Blood collection for biomarker measurement, including glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1).
- Continuous use of a health-monitoring device for 3 months.
- Follow-up assessments by telephone at 14 days and 90 days.
- Completion of a daily symptom inventory via WHOOP/smartphone.
Exclusion Criteria:
- Pre-existing neurological disability or pre-injury condition that would have resulted in a Glasgow Outcome Scale-Extended (GOS-E) score \<8 if assessed before the injury.
- High risk of loss to follow-up, including patients without a reliable phone, those experiencing homelessness, those who are incarcerated, or those who are wards of the state.
- Pregnancy at the time of enrollment.
- Inability to speak English or Spanish, which would prevent completion of the required assessments.
Study population
Adult patients aged 18 to 65 years at the time of enrollment who present to participating emergency departments (EDs) with suspected traumatic brain injury (TBI) meeting the 2023 American Congress of Rehabilitation Medicine (ACRM) criteria and a Glasgow Coma Scale (GCS) score of 15. Key exclusion criteria include pre-existing neurological disability resulting in a pre-injury Glasgow Outcome Scale-Extended (GOS-E) score \<8, high risk of loss to follow-up (e.g., no reliable phone, homelessness, incarceration, or ward of the state), pregnancy, and inability to speak English or Spanish
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not reported
- Masking
- Not reported
GCS 15 TBI patients
Patients presenting to a study emergency department with a Glasgow Coma Scale (GCS) score of 15 and traumatic brain injury (TBI).
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Functional recovery
Time frame: 3 months
Functional recovery will be assessed using the Glasgow Outcome Scale-Extended (GOS-E). The GOS-E rates patient status on one of eight levels. The minimum score is 1 and the maximum score is 8: 1 = death; 2 = vegetative state; 3 = lower severe disability; 4 = upper severe disability; 5 = lower moderate disability; 6 = upper moderate disability; 7 = lower good recovery; and 8 = upper good recovery.
Secondary measures
Daily symptom burden
Time frame: Up to 90 days
Daily symptom burden will be measured using five commonly endorsed items-fatigue, headache, poor concentration, frustration, and sleep problems-from the Rivermead Post-Concussion Questionnaire (RPQ), a validated instrument that assesses post-concussive symptom severity. Each symptom is rated from 0 to 4, with 0 indicating that the symptom is not experienced and 4 indicating a severe problem. Scores for the five items are summed to yield a total score ranging from 0 to 20, with higher scores indicating greater daily post-concussive symptom burden.
Heart rate variability (HRV)
Time frame: Up to 90 days
HRV will be continuously measured using the WHOOP wearable device. HRV will be reported in milliseconds (ms) and reflects variation in the time intervals between successive heartbeats. HRV is a continuous physiological measure with no predefined minimum or maximum value. Higher or lower HRV values are not inherently classified as better or worse outcomes; values will be evaluated as physiological measures in relation to recovery following traumatic brain injury.
Resting heart rate (rHR)
Time frame: Up to 90 days
Physiological outcomes will be continuously measured via the WHOOP wearable device. WHOOP is a wearable health and fitness tracker that continuously monitors key physiological metrics
Sleep patterns - Sleep duration
Time frame: Up to 90 days
Sleep duration will be continuously measured using the WHOOP wearable device. WHOOP is a wearable health and fitness tracker that continuously monitors key physiological metrics.
Sleep patterns - Sleep efficiency
Time frame: Up to 90 days
Sleep efficiency will be continuously measured using the WHOOP wearable device. WHOOP is a wearable health and fitness tracker that continuously monitors key physiological metrics.
Sleep patterns - Sleep latency
Time frame: Up to 90 days
Sleep latency will be continuously measured using the WHOOP wearable device. WHOOP is a wearable health and fitness tracker that continuously monitors key physiological metrics.
Sleep patterns - Total amount of sleep
Time frame: Up to 90 days
Total amount of sleep will be continuously measured using the WHOOP wearable device. WHOOP is a wearable health and fitness tracker that continuously monitors key physiological metrics.
Sleep patterns - percentage of restorative sleep
Time frame: Up to 90 days
Percentage of restorative sleep will be continuously measured using the WHOOP wearable device. WHOOP is a wearable health and fitness tracker that continuously monitors key physiological metrics.
Strain
Time frame: Up to 90 days
Strain will be continuously measured using the WHOOP wearable device. WHOOP is a wearable health and fitness tracker that continuously monitors key physiological metrics.
Body temperature
Time frame: Up to 90 days
Body temperature will be continuously measured using the WHOOP wearable device. WHOOP is a wearable health and fitness tracker that continuously monitors key physiological metrics. ClinicalTrials.gov PRS\_ Protoco…
Oxygen saturation
Time frame: Up to 90 days
Oxygen saturation will be continuously measured using the WHOOP wearable device. WHOOP is a wearable health and fitness tracker that continuously monitors key physiological metrics.
Rivermead Post-Concussion Questionnaire score
Time frame: Up to 2 months
Post-concussive symptoms will be assessed using the Rivermead Post-Concussion Questionnaire (RPQ). The RPQ assesses 16 common post-concussive symptoms, with each symptom rated from 0 to 4, where 0 indicates that the symptom is not experienced, 1 indicates no more of a problem than before the injury, and 2-4 indicate mild, moderate, or severe problems, respectively. For standard scoring, responses of 1 are scored as 0, resulting in a total score ranging from 0 to 64. Higher scores indicate greater post-concussive symptom burden and therefore a worse outcome.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (5)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
5 locations
Harbor-UCLA Medical CenterTorrance, California, United StatesNot yet recruiting
University of MichiganAnn Arbor, Michigan, United StatesRecruiting
Henry Ford MacombClinton Township, Michigan, United StatesRecruiting
Henry Ford HospitalDetroit, Michigan, United StatesRecruiting
Oregon Health & Science UniversityPortland, Oregon, United StatesNot yet recruiting
Study team and timeline
- Lead sponsor
- University of Michigan
- Study start
- Oct 20, 2026 Actual
- Primary completion
- Dec 31, 2028 Estimated
- Study completion
- Aug 30, 2029 Estimated
- First posted
- Oct 5, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Deployment of a Novel NINDS Clinical, Biomarker, Imaging, and Modifiers (CBI-M) Classification Framework for ED Patients With GCS 15 TBI (PIONEER-Prognosis)
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026