Concussion, Brain
Conditions
Brief 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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTNeuraCeq PET imaging with intravenous (IV) dose of 300MBq of Neuraceq™ ([F-18]Florbetaben)
Participants will receive an intravenous (IV) dose of 300 MBq of Neuraceq™ in a volume of 10 mL or less. A 30 minute duration PET image will be acquired starting immediately after Neuraceq™ injection. A second 20-minute duration PET image will be acquired starting 90 minutes after Neuraceq™ injection.
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuraceq™ PET Imaging | Up to 90 minutes after injection | Participants will receive an intravenous (IV) dose of 300 MBq of Neuraceq™ (\[F-18\]Florbetaben) in a volume of 10 mL or less. A 30 minute duration PET image will be acquired starting immediately after Neuraceq™ injection. A second 20-minute duration PET image will be acquired starting 90 minutes after Neuraceq™ 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. |
| Cognitive Assessment_1 | within 24 hours of [F-18]Florbetaben PET imaging | 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. |
| Cognitive Assessment_2 | within 24 hours of [F-18]Florbetaben PET imaging | 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). |
Countries
United States
Outcome results
None listed