Role of NeuraceqTM (Florbetaben F18 Injection) PET in Young Athletes With and Without Persistent Cognitive Complaints Following Multiple Concussions: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Cognitive Assessment_2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Cognitive Assessment_2
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Marc A. Seltzer
Principal Investigator, Section Chief, Diagnostic Radiology
Dartmouth-Hitchcock Medical Center