PET-MRI and the Effect of N-Acetyl Cysteine (NAC) and Anti-Inflammatory Diet in Traumatic Brain Injury

The purpose of this project will be to create a comprehensive, extensive, longitudinal
diagnostic evaluation of cTBI patients. The evaluation uses a battery of neurocognitive
tests, laboratory levels of specific inflammatory compounds, and functional MRI, PET, and
quantitative EEG. Participants shall be evaluated with this overall test battery initially,
and then at approximately 3 and 6 months to determine the time course of changes within the
brain associated with an integrative medicine approach. Three groups of participants will be
enrolled in the study: anti-inflammatory diet group, a group who receive N-acetyl cysteine,
and control group. NAC, is the N-acetyl derivative of the naturally occurring amino acid,
L-cysteine. It is a common over-the-counter supplement that is also available as an
injectable pharmaceutical that protects the liver in cases of acetaminophen overdose.
Laboratory studies have displayed some benefits to use of NAC. It has the potential to reduce
markers of oxidative damage, protect against cell death, and to increase glutathione in
blood, which might be useful in preventing oxidative damage in TBI patients.

Inclusion Criteria:

- 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 at Thomas Jefferson
University, Marcus Institute of Integrative Medicine Centers in Pennsylvania.

- 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 and must
practice effective contraception during the period of pilot study. In addition, male
subjects who have a partner of childbearing age should practice effective
contraception.

Exclusion Criteria:

- Previous brain surgery.

- Score on Mini-Mental Status examination 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 diabetes, asthma, gastroesophageal reflex
disease, or thyroid conditions.