Deployment of a Novel NINDS Clinical, Biomarker, Imaging, and Modifiers (CBI-M) Classification Framework for ED Patients With GCS 15 TBI (PIONEER-Prognosis)
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Department of Defense- Defense Health Program
observational
500
1 country
5
Study Start
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 29, 2026
Actual (reported)October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 5, 2026
Actual (reported)December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
3 months
Daily symptom burden
Up to 90 days
Heart rate variability (HRV)
Up to 90 days
Resting heart rate (rHR)
Up to 90 days
Sleep patterns - Sleep duration
Up to 90 days
Sleep patterns - Sleep efficiency
Up to 90 days
Patients presenting to a study emergency department with a Glasgow Coma Scale (GCS) score of 15 and traumatic brain injury (TBI).
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
Harbor-UCLA Medical Center
Torrance, California, 90509, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Macomb
Plasma samples at baseline
Frederick Korley, MD, PhD
University of Michigan
First Submitted
September 29, 2026
First Posted
October 5, 2026
Study Start
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2028
Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials
Contact the study team to confirm eligibility.
Clinton Township, Michigan, 48038, United States
Henry Ford Hospital
Detroit, Michigan, 48202 ·, United States
Oregon Health & Science University
Portland, Oregon, 97239-3098, United States
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 13, 2026
Record last verified: 2026-10
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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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