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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Page 1 of 1 (2 locations)

1

Boston University Medical Center

Boston, Massachusetts, United States, 02118

2

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02215