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



Status:Recruiting
Conditions:Hospital, Neurology
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 80
Updated:1/19/2018
Start Date:June 7, 2017
End Date:February 11, 2021
Contact:Nancy Wintering, LCSW
Email:nancy.wintering@jefferson.edu
Phone:2155033423

Use our guide to learn which trials are right for you!

Defining Neurobiological Signatures for Chronic Traumatic Brain Injury Using PET-MRI

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 estimated costs at greater than 60 billion dollars. However, there is a lack
of studies using comprehensive diagnostic imaging tools to better understand physiological
ramifications of the injury that may help guide therapy.

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.
We found this trial at
2
sites
789 Lancaster Avenue
Villanova, Pennsylvania 19085
Principal Investigator: Andrew B Newberg, MD
Phone: 215-503-3423
?
mi
from
Villanova, PA
Click here to add this to my saved trials
925 Chestnut Street
Philadelphia, Pennsylvania 19107
Principal Investigator: Andrew B Newberg, MD
Phone: 215-503-3423
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials