PET Imaging in Chronic Traumatic Encephalopathy

NCT02211820 | Completed

• 2 other identifiers: 14016414-M-0164
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Chronic traumatic encephalopathy (CTE) is a brain disease caused in part by head injury. The brain changes from CTE can only be seen at autopsy. Researchers want to test a new brain scan to help diagnose CTE in living patients. Objective: \- To determine if a new type of brain scan can detect changes that occur in chronic traumatic encephalopathy. Eligibility: \- Adults age 18 60 with previous head injury or participation in certain sports. Design:

• Participants will be screened with:
• Physical exam
• Blood and urine tests
• Tests of thinking, mood, and memory
• 30-minute magnetic resonance imaging (MRI) brain scan. A magnetic field and radio waves take pictures of the brain. Participants will lie on a table that slides into a metal cylinder. They will get earplugs for the loud knocking sounds.
• Visit 1: Participants will have a 70-minute PET scan of the brain with a small amount of a radioactive chemical. That will be injected through an intravenous tube (catheter) in each arm. A catheter will also be put into an artery at the wrist or elbow.
• Participants will lie on a bed that slides in and out of a donut-shaped scanner. A plastic mask may be molded to their face and head. Vital signs and heart activity will be checked before and during the scan.
• Blood and urine will be taken before and after the scan.
• Participants will be checked on by phone the next day.
• Visit 2: Participants will repeat Visit 1 with a different chemical and no artery catheter.
• Visit 3: Participants may have a spinal tap. Some fluid will be removed by needle between the bones in the back.

Conditions

Brain Disease; Brain Mapping

Keywords

Encephalopathy; Imaging Studies; Dementia; Cerebellar Cortical Atrophy

Outcome Measures

Primary Outcomes (1)

• Amount of 11C-PBB3 binding in brain as measured with PET

  1 year

Secondary Outcomes (1)

• Amount of brain atrophy as measured with MRI.Amount of 11C-PIB binding in brain as measured with PET

  1 year

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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• For patients:
• History of head injury resulting from past or current participation in one or more contact sports (hockey, football, or boxing). Patients may have history of structural brain injury (i.e., injury accompanying abnormality on MRI or CT scan), concussion without structural injury (mild TBI), or repetitive sub-concussive injury.
• Meets DMS-V criteria for Major Neurocognitive Disorder or Mild Neurocognitive Disorder
• Age 18 to 60 years.
• Ambulatory.
• Patients unable to provide informed consent must have a surrogate decision maker.
• For healthy controls:
• Healthy without past or present history of brain disease.
• Age 18 to 60 years.
• Able to provide informed consent.

You may not qualify if:

• Past or present history of a brain disorder other than TBI.
• For patients: Subjects with abnormal brain imaging findings that suggest a diagnosis other than TBI or a second lesion such as brain tumor in addition to the changes consistent with TBI.
• For controls: past or present history of either a single concussion or more severe TBI, or of repetitive sub-concussive injury due to contact sport participation.
• Serious medical conditions, which make study procedures of the current study unsafe. Such serious medical conditions include uncontrolled epilepsy and multiple serious injuries. The Principal Investigator of this protocol will determine whether the subject needs to be excluded.
• The DSM-V criteria for Major Neurocognitive Disorder are as follows:
• Evidence of significant cognitive decline from a previous level of performance in one or more cognitive domains (complex attention, executive function, learning and memory, perceptual-motor, or social cognition) based on:
• Concern of the individual, a knowledgeable informant, of the clinician that there has been a significant decline in cognitive function.
• A substantial impairment in cognitive performance, preferably documented by standardized neuropsychological testing, or, in its absence, another qualified clinical assessment.
• The cognitive deficits interfere with independence in everyday activities (i.e. at a minimum, requiring assistance with complex instrumental activities of daily living such as paying bills or managing medications)
• The cognitive deficits do not occur exclusively in the context of delirium.
• The cognitive disorder is not better explained by another mental disorder (e.g. major depressive disorder, schizophrenia).
• Criteria for Mild Neurocognitive Disorder are as follows:
• There is evidence of modest cognitive decline from a previous level of performance in one or more of the domains outlined above based on:
• Concern of the individual, a knowledgeable informant, or the clinician.
• Decline in neurocognitive performance, preferably documented by standardized neuropsychological testing, or, in its absence, another qualified clinical assessment.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Baugh CM, Stamm JM, Riley DO, Gavett BE, Shenton ME, Lin A, Nowinski CJ, Cantu RC, McKee AC, Stern RA. Chronic traumatic encephalopathy: neurodegeneration following repetitive concussive and subconcussive brain trauma. Brain Imaging Behav. 2012 Jun;6(2):244-54. doi: 10.1007/s11682-012-9164-5.

  PMID: 22552850 BACKGROUND

• Braskie MN, Klunder AD, Hayashi KM, Protas H, Kepe V, Miller KJ, Huang SC, Barrio JR, Ercoli LM, Siddarth P, Satyamurthy N, Liu J, Toga AW, Bookheimer SY, Small GW, Thompson PM. Plaque and tangle imaging and cognition in normal aging and Alzheimer's disease. Neurobiol Aging. 2010 Oct;31(10):1669-78. doi: 10.1016/j.neurobiolaging.2008.09.012. Epub 2008 Nov 11.

  PMID: 19004525 BACKGROUND

• Chien DT, Bahri S, Szardenings AK, Walsh JC, Mu F, Su MY, Shankle WR, Elizarov A, Kolb HC. Early clinical PET imaging results with the novel PHF-tau radioligand [F-18]-T807. J Alzheimers Dis. 2013;34(2):457-68. doi: 10.3233/JAD-122059.

  PMID: 23234879 BACKGROUND

MeSH Terms

Conditions

Brain Diseases; Dementia

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Robert B Innis, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 8, 2014
• Study Start: August 1, 2014
• Primary Completion: June 20, 2016
• Study Completion: October 12, 2016
• Last Updated: July 5, 2018

Record last verified: 2016-10-12

Locations

US (1)