NCT03241732
PET-MRI in Chronic Traumatic Brain Injury (CTBI)
Enrolling by Invitation
NAAges 18–80InterventionalDiagnosticThomas Jefferson UniversityInvestigator-initiated
~150 participants
Updated 2025-07-29 on ClinicalTrials.gov
What's tested:Anti-inflammatory DietN-acetyl CysteineNeuro Emotive Technique
At a glance
Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fluorodeoxyglucose positron emission tomography (FDG-PET).
Measured over Baseline in the primary study for waitlist and control groups, not in the NET substudy.
+1 more outcome measured
Conditions
Where it's being run
2 sites across 1 statesPennsylvania2
Study leadership
- Andrew B. Newberg, MD · PRINCIPAL_INVESTIGATOR · Thomas Jefferson University
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
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.
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
What this trial measures
- Fluorodeoxyglucose positron emission tomography (FDG-PET).Baseline in the primary study for waitlist and control groups, not in the NET substudy.
To measure inflammation and oxidative damage in the brain.
- Functional magnetic resonance imaging (fMRI).NET Substudy: Baseline, 90 ± 30 days and 180 ± 30 days.
This scan will be used to assess functional connectivity, tractography, and brain volume.