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Brain Imaging for Concussion in Former NFL Players

Phase 1
Waitlist Available
Led By Kevin Guskiewicz, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages between 50-70
No prior exposure to football, collision sports, or prior concussions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-year follow-up
Awards & highlights

Study Summary

This trialstudies brain health of former NFL players to see if concussions and sub-concussive exposure causes long-term effects. It uses detailed tests, such as MRI and PET, to understand and help those at risk.

Who is the study for?
This study is for former NFL players aged between 50-70 who have retired from professional football and have at least one year of NFL experience. It's also for individuals without prior exposure to football or other collision sports and concussions, matched by age and intellectual functioning to the player group.Check my eligibility
What is being tested?
The trial is examining how concussions affect long-term brain health in ex-NFL players using advanced MRI, PET scans with new tracers ([18F] PBR111, [18F] Flortaucipir, [11C] PiB), blood tests for biomarkers, and genetic testing over a five-year period.See study design
What are the potential side effects?
Since this study involves diagnostic procedures rather than treatments, there are minimal side effects expected. However, some may experience discomfort or reactions related to the MRI or PET scan processes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 50 and 70 years old.
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I have never played football, collision sports, or had a concussion.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-year follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-year follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Plasma Aliquots between Timepoints
Change in RNA between Timepoints
Change in Saliva Collection between Timepoints
+48 more
Secondary outcome measures
Alcohol Use Disorders Identification Test (AUDIT) at 3-Year Follow-Up
Alcohol Use Disorders Identification Test (AUDIT) at Baseline
Ascertain Dementia 8-Item (AD-8) Screening Interview Score at 3-Year Follow-Up
+93 more

Trial Design

10Treatment groups
Experimental Treatment
Group I: Medium Cognitive Functioning/Medium Concussion HistoryExperimental Treatment3 Interventions
Former NFL Players with medium cognitive functioning and medium concussion history with be included in this group.
Group II: Medium Cognitive Functioning/Low Concussion HistoryExperimental Treatment3 Interventions
Former NFL Players with medium cognitive functioning and low concussion history with be included in this group.
Group III: Medium Cognitive Functioning/High Concussion HistoryExperimental Treatment3 Interventions
Former NFL Players with medium cognitive functioning and high concussion history with be included in this group.
Group IV: Low Cognitive Functioning/Medium Concussion HistoryExperimental Treatment3 Interventions
Former NFL players with low cognitive function and medium concussion history will be included in this group.
Group V: Low Cognitive Functioning/Low Concussion HistoryExperimental Treatment3 Interventions
Former NFL players with low cognitive function and low concussion history will be included in this group.
Group VI: Low Cognitive Functioning/High Concussion HistoryExperimental Treatment3 Interventions
Former NFL players with low cognitive function and high concussion history will be included in this group.
Group VII: High Cognitive Functioning/Medium Concussion HistoryExperimental Treatment3 Interventions
Former NFL Players with high cognitive functioning and high concussion history with be included in this group.
Group VIII: High Cognitive Functioning/Low Concussion HistoryExperimental Treatment3 Interventions
Former NFL players with high cognitive function and low concussion history will be included in this group.
Group IX: High Cognitive Functioning/ High Concussion HistoryExperimental Treatment3 Interventions
Former NFL players with high cognitive function and high concussion history will be included in this group.
Group X: Healthy Male ControlsExperimental Treatment3 Interventions
Healthy male demographically matched controls will be included in this group.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
[18F] PBR111
2010
Completed Phase 1
~20

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,504 Previous Clinical Trials
4,187,412 Total Patients Enrolled
Boston Children's HospitalOTHER
760 Previous Clinical Trials
5,579,430 Total Patients Enrolled
Medical College of WisconsinOTHER
609 Previous Clinical Trials
1,162,351 Total Patients Enrolled

Media Library

Low Cognitive Functioning/Medium Concussion History Clinical Trial Eligibility Overview. Trial Name: NCT04263337 — Phase 1
Concussion Research Study Groups: Low Cognitive Functioning/Medium Concussion History, High Cognitive Functioning/Low Concussion History, Low Cognitive Functioning/Low Concussion History, Low Cognitive Functioning/High Concussion History, Healthy Male Controls, Medium Cognitive Functioning/Low Concussion History, Medium Cognitive Functioning/High Concussion History, High Cognitive Functioning/Medium Concussion History, High Cognitive Functioning/ High Concussion History, Medium Cognitive Functioning/Medium Concussion History
Concussion Clinical Trial 2023: Low Cognitive Functioning/Medium Concussion History Highlights & Side Effects. Trial Name: NCT04263337 — Phase 1
Low Cognitive Functioning/Medium Concussion History 2023 Treatment Timeline for Medical Study. Trial Name: NCT04263337 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How large is the current cohort for this clinical research?

"Unfortunately, no further participants are needed for this trial; it was initially posted on March 12th 2020 and the most recent update was November 23rd 2022. However, there are currently 76 different trials recruiting patients with concussion or brain issues and 2 distinct studies for this intervention that still require enrolment."

Answered by AI

Has this treatment been tested in other medical experiments?

"The therapeutic intervention was initially investigated in 2018 by Mayo Clinic. At present, two completed studies and two active trials exist; a considerable portion of these are administered out of Chapel Hill, North carolina."

Answered by AI

May I participate in this research experiment?

"Admission to this medical trial requires that participants have experienced a concussion, possess healthy brain tissue and fall in between the ages of 50-70. 250 individuals are needed for successful enrolment."

Answered by AI

Is this investigation actively looking for older adults to join the trial?

"This clinical trial has a narrow age requirement, seeking out patients between 50 and 70. There are separate studies for those younger than 18 or older than 65 with 26 and 35 trials respectively."

Answered by AI

Is there an open window for enrolling in this analysis?

"According to clinical trials.gov, this medical trial is not presently recruiting participants. Initially posted on March 12th 2020 and last updated on November 23rd 2022, the study has yet to accept any patients; however 78 other studies are actively enrolling at this time."

Answered by AI

Is this remedy risk-free for individuals?

"Our internal evaluation gives this treatment a rating of 1 due to the few data points available in Phase 1 trials that support its efficacy and safety."

Answered by AI

What purport does this research endeavor to achieve?

"The primary outcome sought by this clinical trial, to be measured at the baseline is Radial Diffusivity (RD) as derived from Tract-Based Diffusion. Secondary outcomes encompass Alcohol Use Disorders Identification Test (AUDIT), National Institute of Health Toolbox Cognitive Battery and Drug Abuse Screening Test-10 (DAST-10). These tests evaluate hazardous alcohol use, dependence symptoms, cognitive functioning and drug abuse over a 3 year followup respectively with scores ranging from 0 - 40 for AUDIT, infinite range for NIHTBXCogBatt and 0 - 10 for DAST-10."

Answered by AI
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~70 spots leftby Dec 2025