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Neuraceq™ PET for Detection of Brain Changes in Young Athletes Post-concussion

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Dartmouth Health

Status

Completed

Conditions

Concussion, Brain

Treatments

Diagnostic Test: NeuraCeq PET imaging with intravenous (IV) dose of 300MBq of Neuraceq™ ([F-18]Florbetaben)

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 2 patient groups

Athletes with mild to moderate traumatic brain injury (mTBI) and good outcome
Active Comparator group
Description:
Young athletes who have sustained one or more concussions without persistent cognitive complaints at least one year post-injury
Treatment:
Diagnostic Test: NeuraCeq PET imaging with intravenous (IV) dose of 300MBq of Neuraceq™ ([F-18]Florbetaben)
Athletes with persistent cognitive deficits due to mild to moderate traumatic brain injury (mTBI)
Active Comparator group
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.
Treatment:
Diagnostic Test: NeuraCeq PET imaging with intravenous (IV) dose of 300MBq of Neuraceq™ ([F-18]Florbetaben)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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