Traumatic Brain InjuryNCT07858266
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)
An observational study of Traumatic Brain Injury, run by University of Michigan at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 500 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2026to 30 Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
University of Michigan
Ann Arbor, Michigan, 48109
Devon Newman, MS, 734-763-1702, devonn@med.umich.edu
Frederick Korley, MD, PhD
Henry Ford Macomb
Clinton Township, Michigan, 48038
Kathleen Mays-Wilson, 313-916-9551, Kwilso10@hfhs.org
Joseph Miller, MD, MS
Henry Ford Hospital
Detroit, Michigan, 48202 ·
Kathleen Mays-Wilson, 313-916-9551, Kwilso10@hfhs.org
Joseph Miller, MD, MS
Oregon Health & Science University
Portland, Oregon, 97239-3098
Maja Strusinska-Thayer, (503) 418-2713, strusins@ohsu.edu
Bori Kea, MD, MCR
Harbor-UCLA Medical Center
Torrance, California, 90509
Yesenia Perez, 7472103472, yperez@dhs.lacounty.gov
Kabir Yadav, MD, MS, MSHS,
About this study
Official title: Deployment of a Novel NINDS Clinical, Biomarker, Imaging, and Modifiers (CBI-M) Classification Framework for ED Patients With GCS 15 TBI (PIONEER-Prognosis)
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 detailed 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.
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury, prognosis, biomarker, wearable, gfap, uch-l1, GCS 15 TBI, whoop
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 is being measured
The primary outcome is the main question the study is designed to answer.
Functional recovery
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.
Measured: 3 months
Secondary outcomes (12)
Daily symptom burden
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.
Measured: Up to 90 days
Heart rate variability (HRV)
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.
Measured: Up to 90 days
Resting heart rate (rHR)
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
Measured: Up to 90 days
Sleep patterns - Sleep duration
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.
Measured: Up to 90 days
Sleep patterns - Sleep efficiency
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.
Measured: Up to 90 days
Sleep patterns - Sleep latency
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.
Measured: Up to 90 days
Sleep patterns - Total amount of sleep
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.
Measured: Up to 90 days
Sleep patterns - percentage of restorative sleep
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.
Measured: Up to 90 days
Strain
Strain will be continuously measured using the WHOOP wearable device. WHOOP is a wearable health and fitness tracker that continuously monitors key physiological metrics.
Measured: Up to 90 days
Body temperature
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…
Measured: Up to 90 days
Oxygen saturation
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.
Measured: Up to 90 days
Rivermead Post-Concussion Questionnaire score
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.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startOct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Frederick Korley, MD, PhD, University of Michigan
- Investigators
- Frederick Korley, MD, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858266
- Sponsor's protocol ID
- HUM00284360
- Other IDs
- HT942524TBIPHRPFPA
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data collected during this study may be retained for future secondary analyses and will be shared in accordance with applicable U.S. Department of Defense (DoD) data-sharing policies and requirements.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deployment of a Novel NINDS Clinical, Biomarker, Imaging, and Modifiers (CBI-M) Classification Framework for ED Patients With GCS 15 TBI (PIONEER-Prognosis)
- ClinicalTrials.gov ID
- NCT07858266
- Acronym / sponsor ID
- HUM00284360
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury, prognosis, biomarker, wearable, gfap, uch-l1, GCS 15 TBI, whoop
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- Oct 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Aug 2029 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
12 secondary outcomes
Daily symptom burden
Time frame: Up to 90 days
Heart rate variability (HRV)
Time frame: Up to 90 days
Resting heart rate (rHR)
Time frame: Up to 90 days
Sleep patterns - Sleep duration
Time frame: Up to 90 days
Sleep patterns - Sleep efficiency
Time frame: Up to 90 days
Sleep patterns - Sleep latency
Time frame: Up to 90 days
Sleep patterns - Total amount of sleep
Time frame: Up to 90 days
Sleep patterns - percentage of restorative sleep
Time frame: Up to 90 days
Strain
Time frame: Up to 90 days
Body temperature
Time frame: Up to 90 days
Oxygen saturation
Time frame: Up to 90 days
Rivermead Post-Concussion Questionnaire score
Time frame: Up to 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data collected during this study may be retained for future secondary analyses and will be shared in accordance with applicable U.S. Department of Defense (DoD) data-sharing policies and requirements.
Related trials for Traumatic Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frederick Korley, MD, PhD principal investigator
University of Michigan
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by University of Michigan at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Devon Newman, MS (734-764-1602, devonn@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional recovery (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.