Functional Brain Imaging in PTSD

NCT02053532 | Completed DMC

• 1 other identifier: S13-00313
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with post-traumatic stress disorder (PTSD) have abnormalities in the function of the amygdala and medial prefrontal cortex (particularly anterior cingulate), in addition to abnormalities of hippocampal volume. In this pilot study we propose to use the combined positron emission tomography/magnetic resonance (PET/MR) scanner and F-18-fluorodeoxyglucose (FDG, an analog of glucose, the most commonly used PET ligand) to examine brain function and directly correlate the data with the intrinsic functional connectivity of brain circuits that are responsible for social, emotional and cognitive processing in both individuals with PTSD and group-matched trauma controls (TC) and healthy controls (HC). Once the machine is validated, we will then use a more specific biomarker to better understand the neurochemical factors that contribute to individual differences in PTSD. Thus, the data obtained from this pilot study will guide our future molecular imaging studies. The link between general brain function, specific molecular target and the intrinsic functional connectivity of brain circuits that are responsible for social, emotional and cognitive processing in PTSD, TC and HC will be explored.

Conditions

Post-traumatic Stress Disorder (PTSD); Trauma

Keywords

Trauma; Post-traumatic stress disorder (PTSD); Imaging; Neuroimaging; F-18-fluorodeoxyglucose (FDG)

Outcome Measures

Primary Outcomes (1)

• F-18- fluorodeoxyglucose (FDG) metabolism in the brain of healthy controls (HC) vs trauma controls (TC) vs individuals with post-traumatic stress disorder (PTSD)

  In this pilot study we propose to use the combined positron emission tomography/magnetic resonance (PET/MR) scanner and F-18-fluorodeoxyglucose (FDG, an analog of glucose, the most commonly used PET ligand) to examine brain function and directly correlate the data with the intrinsic functional connectivity of brain circuits that are responsible for social, emotional and cognitive processing in both individuals with post-traumatic stress disorder (PTSD) and group-matched trauma controls (TC) and healthy controls (HC). These groups are matched based on gender, age and ethnicity. Once the machine is validated, we will then use a more specific biomarker to better understand the neurochemical factors that contribute to individual differences in PTSD. The link between general brain function, specific molecular target and the intrinsic functional connectivity of brain circuits that are responsible for social, emotional and cognitive processing in PTSD, TC and HC will be explored.

  Two months

Study Arms (1)

Positron emission tomography/magnetic resonance imaging

Procedure: Positron emission tomography/magnetic resonance imaging

Interventions

Positron emission tomography/magnetic resonance imaging PROCEDURE

Positron emission tomography/magnetic resonance (PET/MR) imaging using 18-F-fluorodeoxyglucose (FDG) as radio tracer

Also known as: PET Imaging

Positron emission tomography/magnetic resonance imaging

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects are between the age range of 18 to 65, are medically healthy and currently not taking any medications to treat any medical illness, and either have no history of post-traumatic stress disorder (PTSD) or have been diagnosed with PTSD.

You may qualify if:

• Age 18-55 years old
• Currently diagnosed with PTSD and symptomatic with a Clinician-Administered PTSD Scale (CAPS) score \> 50

You may not qualify if:

• any primary Axis I disorder other than PTSD (e.g. psychosis)
• medical or neurological illnesses likely to affect physiology or anatomy, i.e. uncontrolled hypertension, cardiovascular disorders
• a history of drug (including benzodiazepines (BZD)) dependence (Diagnostic and Statistical Manual (DSM) IV criteria) within 1 year of the study and lasting longer than 2 years, except for alcohol dependence
• current pregnancy (as documented by pregnancy testing at screening or on the day of PET imaging study)
• current breast feeding
• nicotine dependence
• suicidal ideation or behavior
• Human immunodeficiency virus (HIV) (due to possible neuropsychiatric effects)
• Hepatitis B or C (due to possible neuropsychiatric effects)
• use of opioid medications within 2 weeks of the positron emission tomography (PET) study
• having an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participation in the study
• seriously claustrophobic
• blood donation within 8 weeks prior to the study
• positive alcohol breathalyzer test
• Abnormal thyroid test indicated by thyroid stimulating hormone (TSH) \< .15 mlU/L and/or thyroxine (T4) \> 18 mcg/dL

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: February 3, 2014
• Study Start: May 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: February 1, 2016
• Last Updated: March 3, 2016

Record last verified: 2016-03

Locations

US (1)