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The purpose of the study is to learn if Neuraceqâ„¢ (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.
Former college athletes who sustained at least one previous concussion will undergo computerized neurocognitive testing and a structured questionnaire of present symptoms. [F-18] Florbetaben PET images will be acquired dynamically, with data binned in 20 time frames of 1 min each (early phase), followed by 4 frames of 5 min each (late phase), with image frames summed within each phase after linearly coregistering to subjects' mean images, then elastically transformed to template space of a florbetaben scan used in standardized volume of interest quantification, and intensity normalized to mean voxel value within each phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Athletes with mild to moderate traumatic brain injury (mTBI) and good outcome | Active Comparator | Young athletes who have sustained one or more concussions without persistent cognitive complaints at least one year post-injury |
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| Athletes with persistent cognitive deficits due to mild to moderate traumatic brain injury (mTBI) | Active Comparator | Young athletes who have sustained one or more concussions with persistent cognitive complaints at least one year post-injury in spite of medical and cognitive treatment intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuraCeq PET imaging with intravenous (IV) dose of 300MBq of Neuraceqâ„¢ ([F-18]Florbetaben) | Diagnostic Test | Participants will receive an intravenous (IV) dose of 300 MBq of Neuraceqâ„¢ in a volume of 10 mL or less. A 30 minute duration PET image will be acquired starting immediately after Neuraceqâ„¢ injection. A second 20-minute duration PET image will be acquired starting 90 minutes after Neuraceqâ„¢ injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Neuraceqâ„¢ PET Imaging | Participants will receive an intravenous (IV) dose of 300 MBq of Neuraceqâ„¢ ([F-18]Florbetaben) in a volume of 10 mL or less. A 30 minute duration PET image will be acquired starting immediately after Neuraceqâ„¢ injection. A second 20-minute duration PET image will be acquired starting 90 minutes after Neuraceqâ„¢ injection. Imaging data will be reconstructed using standard iterative reconstruction algorithm and with CT-based attenuation correction. Images will be interpreted both visually and semi-quantitatively (cortical-to-cerebellum standardized uptake value rations) for 6 target cortical regions of interest (frontal, temporal, parietal, anterior cingulate, posterior cingulate, and precuneus), using the whole cerebellum as the reference region. | Up to 90 minutes after injection |
| Cognitive Assessment_1 | Participants will complete a set of cognitive questionnaires to assess presence or absence of cognitive complaints. Altered cognitive performance will be defined as either one score of more than 2 standard deviations or two scores of 1 standard deviation below the age-adjusted norm or estimates of baseline premorbid function (using the Barona Index) on tests of attention and/or memory. | within 24 hours of [F-18]Florbetaben PET imaging |
| Cognitive Assessment_2 | Participants will complete a set of cognitive questionnaires to assess presence or absence of cognitive complaints. Significant cognitive complaints will be defined as scores of 1 standard deviation below the mean on the Multiple Ability Self-Report Questionnaire (MASQ). | within 24 hours of [F-18]Florbetaben PET imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc A Seltzer, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
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| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |