Status:
ENROLLING_BY_INVITATION
PET-MRI in Chronic Traumatic Brain Injury (CTBI)
Lead Sponsor:
Thomas Jefferson University
Conditions:
Chronic Traumatic Brain Injury
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Chronic Traumatic Brain Injury (cTBI) symptoms exist in individuals who experienced previous traumatic brain injuries. There are 80-90 thousand individuals who are clinically diagnosed with cTBI, with...
Detailed Description
The purpose of this project was to create a comprehensive, extensive, longitudinal diagnostic evaluation of cTBI patients. The evaluation uses a battery of neurocognitive tests, laboratory levels of s...
Eligibility Criteria
Inclusion
- Individuals with a history of TBI and complaints of persistent symptoms including cognitive impairment, emotional disturbances, headache, or other symptoms associated with TBI
- Age 18-80 years old
- Patients had no other pre-existing history (i.e. prior to the TBI) of significant medical, neurological, or psychological disorders such as schizophrenia or active substance abuse.
- Minor, stable health problems that should have no substantial effect on cerebral blood flow will be allowed (i.e. controlled hypertension, medication controlled diabetes)
- Able to give informed consent and willing to complete the study
- Patients will be allowed to be taking medications or supplements at the initial intake, but they must be on a stable dose regimen for at least 1 month
- Women of childbearing potential will confirm a negative pregnancy test NET Substudy: Anxiety and/or distress associated with TBI or TBI symptoms by measurement with Subjective Units of Distress, and biofeedback screening
Exclusion
- Previous brain surgery.
- Cognitive impairment with significant impact on activities of daily living and/or a score on the Mini-Mental Status examination (or similar) of 25 or lower
- Intracranial abnormalities that may complicate interpretation of the brain scans (e.g., stroke, tumor, vascular abnormality affecting the target area).
- Pregnant or lactating women.
- Enrollment in active clinical trial/ experimental therapy within the prior 30 days.
- Any pre-existing medical conditions that may interfere with cerebral function.
- Subject is unable or unwilling to lie still in the scanner (i.e. due to claustrophobia or weight \> 350 pounds)
- Subject has metal in their body or other reason that they cannot undergo magnetic resonance imaging.
- Additional exclusionary criteria for the NAC arm:
- Patients taking medications that might interact with the NAC involved in this study will be evaluated on a case by case basis by the PI or study physician.
- Patients that have a history of uncontrolled conditions, e.g.: diabetes, asthma, gastroesophageal reflex disease, or thyroid conditions
Key Trial Info
Start Date :
June 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 8 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03241732
Start Date
June 7 2017
End Date
July 8 2027
Last Update
July 29 2025
Active Locations (2)
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1
Thomas Jefferson University, Marcus Institute of Integrative Health Centers
Philadelphia, Pennsylvania, United States, 19107
2
Thomas Jefferson University, Marcus Institute of Integrative Health Centers
Villanova, Pennsylvania, United States, 19085