Back to resultsNeuraceq™ PET for Detection of Brain Changes in Young Athletes Post-concussion
Primary Purpose
Concussion, Brain
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NeuraCeq PET imaging with intravenous (IV) dose of 300MBq of Neuraceq™ ([F-18]Florbetaben)
Sponsored by
About this trial
This is an interventional other trial for Concussion, Brain
Eligibility Criteria
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
Sites / Locations
- Dartmouth-Hitchcock Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Athletes with mild to moderate traumatic brain injury (mTBI) and good outcome
Athletes with persistent cognitive deficits due to mild to moderate traumatic brain injury (mTBI)
Arm Description
Young athletes who have sustained one or more concussions without persistent cognitive complaints at least one year post-injury
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.
Outcomes
Primary Outcome Measures
Neuraceq™ PET Imaging
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
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
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT05270083
First Posted
February 24, 2022
Last Updated
September 5, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05270083
Brief Title
Neuraceq™ PET for Detection of Brain Changes in Young Athletes Post-concussion
Official Title
Role of NeuraceqTM (Florbetaben F18 Injection) PET in Young Athletes With and Without Persistent Cognitive Complaints Following Multiple Concussions: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 13, 2017 (Actual)
Primary Completion Date
October 10, 2019 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Brain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Athletes with mild to moderate traumatic brain injury (mTBI) and good outcome
Arm Type
Active Comparator
Arm Description
Young athletes who have sustained one or more concussions without persistent cognitive complaints at least one year post-injury
Arm Title
Athletes with persistent cognitive deficits due to mild to moderate traumatic brain injury (mTBI)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
NeuraCeq PET imaging with intravenous (IV) dose of 300MBq of Neuraceq™ ([F-18]Florbetaben)
Other Intervention Name(s)
18F-Florbetaben
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neuraceq™ PET Imaging
Description
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.
Time Frame
Up to 90 minutes after injection
Title
Cognitive Assessment_1
Description
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.
Time Frame
within 24 hours of [F-18]Florbetaben PET imaging
Title
Cognitive Assessment_2
Description
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).
Time Frame
within 24 hours of [F-18]Florbetaben PET imaging
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc A Seltzer, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neuraceq™ PET for Detection of Brain Changes in Young Athletes Post-concussion
We'll reach out to this number within 24 hrs