Neuraceq™ PET for Detection of Brain Changes in Young Athletes Post-concussion (NCT05270083) | Clinical Trial Compass
CompletedNot Applicable
Neuraceq™ PET for Detection of Brain Changes in Young Athletes Post-concussion
United States15 participantsStarted 2017-07-13
Plain-language summary
The purpose of the study is to learn if Neuraceq™ (Florbetaben F 18 Injection) PET can detect changes in the brains of young athletes who sustained one or more concussions with or without persistent cognitive complaints at least 5 years after injury.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18-40 years of age
* A minimum of 1 concussion prior to study entry
* A minimum of one year post first concussion
* mTBI as defined by the American Congress of Rehabilitative Medicine
* Participants in Cohort A must have either subjective or objective evidence of persistent cognitive deficits
Exclusion Criteria:
* Impaired decision-making capacity, i.e. inability to provide informed consent
* Pregnancy
* History of other neurologic disorders (e.g., epilepsy, cerebrovascular disease, neurodegenerative disorders, intellectual disability)
* Significant systemic medical illness
* Current DSM-IV Axis I diagnosis of psychiatric illness
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial used Neuraceq™ PET imaging specifically to look for brain changes after concussion in young athletes, could you explain what kind of brain changes this scan was designed to detect, and whether those findings might be relevant to my situation?
2This trial is already completed — is there any published data or results from it that you've had a chance to review, and what might those findings mean for how we think about my diagnosis or recovery?
3The trial combined PET brain imaging with at least two different types of cognitive assessments — can you help me understand what those cognitive tests were measuring, and how they compare to any cognitive evaluations I've already had?
4Because this was listed as a Phase NA study focused on detection rather than treatment, does that mean it was purely observational, and are there any treatment trials or next steps that might follow from this kind of research that we should be considering?
5Given that this study focused specifically on young athletes after concussion, how relevant do you think its approach or findings are to my own circumstances, and should we be exploring similar imaging or cognitive testing as part of my care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Neuraceq™ PET Imaging
Timeframe: Up to 90 minutes after injection
2
Cognitive Assessment_1
Timeframe: within 24 hours of [F-18]Florbetaben PET imaging
3
Cognitive Assessment_2
Timeframe: within 24 hours of [F-18]Florbetaben PET imaging