Status:
TERMINATED
Imaging [18F]PI-2620 and [18F]Florbetaben in Military Service Members With Blast Related Mild Traumatic Brain Injury
Lead Sponsor:
Life Molecular Imaging SA
Collaborating Sponsors:
Walter Reed National Military Medical Center
Conditions:
Mild Traumatic Brain Injury
Eligibility:
MALE
25-54 years
Phase:
PHASE1
Brief Summary
The main objective of this interdisciplinary study is to develop an understanding of the molecular imaging features of blast-related mild traumatic brain injury (mTBI) in military personnel, while hel...
Detailed Description
The main objective of this interdisciplinary study is to develop an understanding of the molecular imaging features of blast-related mild traumatic brain injury (mTBI) in military personnel, while hel...
Eligibility Criteria
Inclusion
- Male
- Right-handed
- Age 25-54
- Agree to participate in ALL study procedures
- English speaking
- Ambulatory
- Must be able to identify a study partner who is well acquainted with the participant for at least 2 years, to answer questions either in person or over the telephone about the participants' activities of daily living, and to corroborate behavioral and cognitive problems and history of brain injury
- History of combat deployment
- For blast-related mTBI group: must be active duty or DEERS-eligible, currently or formerly enrolled in the 4 week intensive outpatient program at NICoE, have experienced 1 or more blast-related mTBIs during tours of duty and report experiencing changes in mood, behavioral or cognitive problems (blast-related mTBI considered here and confirmed in EMR as: blast exposure from explosive device resulting in mTBI which fits criteria defined by VA DoD mTBI guidelines which include at least one of: at time of injury - LOC 0-30 minutes, AOC up to 24hrs, PTA 0-1 day, GCS 13-15)
- DEERS-eligible for all participants
- For control group 1: history of mTBI with no blast-related mTBIs (as confirmed in EMR and/or by the BISQ and QCube) 12. For control group 2: No lifetime history of TBI (as confirmed by the BISQ and/or EMR)
Exclusion
- Had a moderate or severe brain injury that required hospitalization
- Significant systemic illness or unstable medical conditions including: uncontrolled diabetes mellitus, uncorrected hypothyroidism or hyperthyroidism, or systemic cancer
- Diagnosis of schizophrenia, psychosis, or other psychological disorder (Note: blast-related mTBI group will not be excluded if they have a stable diagnosis of post-traumatic stress disorder, depression and anxiety resulting from their military experience; disorders existing prior to military service will serve as an exclusion)
- Current and active alcohol or substance abuse or dependence (DSM V criteria) within the past 6 months
- Clinically significant laboratory test abnormalities (such as hematology, chemistry, urinalysis, ECG) or significant impairment of liver or renal function
- Significant cerebrovascular disease (such as TIA, stroke) or cardiovascular disease (such as uncontrolled hypertension, atrial fibrillation)
- Impairment of visual or auditory acuity sufficient to interfere with completion of study procedures
- Education level \< 10 years
- The presence of any MRI-incompatible prostheses or ferromagnetic metal, or any other condition that would preclude ability to undergo MRI or PET (such as claustrophobia or obesity, \>350 lbs and/or unable to fit in scanners)
- History of risk factors for torsade de pointes or take drugs known to prolong the QT interval
- Had 2 or more PET scans in the last year, or other significant exposure to radiation (i.e. radiation therapy)
- Diagnosis of neurodegenerative or neurological diseases and dementia (other than CTE) such as Alzheimer's disease, Parkinson's disease, vascular dementia, Huntington's disease, Pick's disease, Lewy Body Dementia, frontotemporal dementia, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, or multiple sclerosis
Key Trial Info
Start Date :
June 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05337774
Start Date
June 7 2021
End Date
April 30 2022
Last Update
May 14 2024
Active Locations (1)
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1
Walter Reed National Military Medical Center (WRNMMC)
Bethesda, Maryland, United States, 20889