PET Imaging in Chronic Traumatic Encephalopathy

Completed

Conditions studied: Brain Disease, Brain Mapping

In brief

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.

Key facts

Study ID

NCT02211820

Run by

National Institute of Mental Health (NIMH)

People needed

6

Starts

2014-08-01

Expected to finish

2016-10-12

Last updated by the study team

2018-07-05

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

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.
• The cognitive deficits are insufficient to interfere with independence (eg, instrumental activities of daily living, like more complex tasks such as paying bills or managing medications,
• are preserved), but greater effort, compensatory strategies, or accommodation may be required to maintain independence.
• The cognitive deficits do not occur exclusively in the context of a delirium.
• The cognitive deficits are not primarily attributable to another mental disorder (eg, major depressive disorder, schizophrenia).
• There are no restrictions on medications. Since disease modifying therapy for tauopathies (including CTE and Alzheimer s disease) do not currently exist, no currently available medications, either prescribed or over-the-counter, are expected to confound the results of this study. Anti-inflammatory medications, including NSAIDs, are not expected to significantly reduce tau aggregation in CTE patients, based on the failure of these medications to prevent disease progression in Alzheimer s disease.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.