Neuraceq™ PET for Detection of Brain Changes in Young Athletes Post-concussion
- Conditions
- Concussion, Brain
- Interventions
- Diagnostic Test: NeuraCeq PET imaging with intravenous (IV) dose of 300MBq of Neuraceq™ ([F-18]Florbetaben)
- Registration Number
- NCT05270083
- Lead Sponsor
- Dartmouth-Hitchcock Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Athletes with mild to moderate traumatic brain injury (mTBI) and good outcome NeuraCeq PET imaging with intravenous (IV) dose of 300MBq of Neuraceq™ ([F-18]Florbetaben) Young athletes who have sustained one or more concussions without persistent cognitive complaints at least one year post-injury Athletes with persistent cognitive deficits due to mild to moderate traumatic brain injury (mTBI) NeuraCeq PET imaging with intravenous (IV) dose of 300MBq of Neuraceq™ ([F-18]Florbetaben) 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.
- Primary Outcome Measures
Name Time Method 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).
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.
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States