Status:
COMPLETED
Tau Imaging of Chronic Traumatic Encephalopathy
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
U.S. Army Medical Research and Development Command
Boston University
Conditions:
Chronic Traumatic Encephalopathy
Eligibility:
MALE
40-69 years
Phase:
PHASE2
Brief Summary
Chronic traumatic encephalopathy (CTE) is a progressive degenerative brain disease with symptoms that include memory loss, problems with impulse control, and depression that can lead to suicide. As th...
Eligibility Criteria
Inclusion
- Presumed CTE Group (includes 20 former NFL players who will have already participated in the NIH-funded R01 "DETECT" (Diagnosis and Evaluation of Traumatic Encephalopathy with Clinical Tests) study (Stern, PI; Shenton, Neuroimaging Site PI). Eligibility criteria for presumed CTE group and the control group are based on findings from the DETECT study.
- significant cognitive impairment (and impairment in at least one of the following):
- behavioral (e.g., impulsivity, aggression),
- mood (e.g., elevated depression measures, elevated suicidality),
- and/or motor (e.g., impairments evidenced in neurological examination;
- demonstrated abnormalities on svMRI, DTI, or MRS
Exclusion
- weight \> 350 lbs
- known metallic implants preventing MRI
- history of stroke
- non-English speaking
- significant vision or hearing impairment
- unable to provide written informed consent
- Control Group (comprised of 5 male participants selected from 50 control subjects in the DETECT study).
- Inclusion Criteria:
- no history of mTBI or exposure to repetitive brain trauma
- normal functioning on DETECT clinical measures
- no abnormalities on svMRI, DTI, or MRS
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02191267
Start Date
January 1 2015
End Date
September 30 2016
Last Update
May 17 2018
Active Locations (2)
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1
Boston University Medical Center
Boston, Massachusetts, United States, 02118
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215