Functional Brain Imaging in PTSD

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.

Study Overview

• Status: Completed
• Conditions: Trauma; Post-traumatic Stress Disorder (PTSD)
• Intervention / Treatment: Procedure: Positron emission tomography/magnetic resonance imaging

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

For Patients with post-traumatic stress disorder (PTSD)

Inclusion criteria:

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

Exclusion criteria:

1. any primary Axis I disorder other than PTSD (e.g. psychosis)
2. medical or neurological illnesses likely to affect physiology or anatomy, i.e. uncontrolled hypertension, cardiovascular disorders
3. 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
4. current pregnancy (as documented by pregnancy testing at screening or on the day of PET imaging study)
5. current breast feeding
6. nicotine dependence
7. suicidal ideation or behavior
8. general magnetic resonance imaging (MRI) exclusion criteria, i.e. pacemakers, metals in the body;
9. Human immunodeficiency virus (HIV) (due to possible neuropsychiatric effects)
10. Hepatitis B or C (due to possible neuropsychiatric effects)
11. use of opioid medications within 2 weeks of the positron emission tomography (PET) study
12. 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
13. seriously claustrophobic
14. blood donation within 8 weeks prior to the study
15. positive alcohol breathalyzer test
16. Abnormal thyroid test indicated by thyroid stimulating hormone (TSH) < .15 mlU/L and/or thyroxine (T4) > 18 mcg/dL
17. Glucose > 200 mg/dL on two separate days

For Healthy Subjects

Inclusion criteria:

1. Age 18-55 years old
2. No personal or first-degree family history of any Axis I diagnosis

Exclusion criteria:

1. . any history or current primary Axis I disorder ;
2. . medical or neurological illnesses likely to affect physiology or anatomy, i.e. uncontrolled hypertension, cardiovascular disorders;
3. . a history of drug (including benzodiazepines [BZD]) dependence (DSM IV criteria) within 1 year of the study and lasting longer than 2 years, except for alcohol dependence;
4. . current pregnancy (as documented by pregnancy testing at screening or on the day of PET imaging study);
5. . current breast feeding;
6. . nicotine dependence;
7. . suicidal ideation or behavior;
8. . general MRI exclusion criteria, i.e. pacemakers, metals in the body;
9. . HIV (due to possible neuropsychiatric effects);
10. . Hepatitis B or C (due to possible neuropsychiatric effects);
11. . use of opioid medications within 2 weeks of the PET study;
12. . having an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participation in the study;
13. . seriously claustrophobic;
14. . blood donation within 8 weeks prior to the study;
15. . positive alcohol breathalyzer test;
16. . Abnormal thyroid test indicated by TSH < .15 mlU/L and/or T4 > 18 mcg/dL;
17. . Glucose > 200 mg/dL on two separate days;
18. . Does not have a lifetime history of trauma.

For Healthy Subjects with Trauma ("Trauma Controls")

Inclusion criteria:

1. . Age 18-55 years old;
2. . No personal or first-degree family history of any Axis I diagnosis;
3. . Has a lifetime history of trauma.

Exclusion criteria:

1. . any history or current primary Axis I disorder ;
2. . medical or neurological illnesses likely to affect physiology or anatomy, i.e. uncontrolled hypertension, cardiovascular disorders;
3. . a history of drug (including benzodiazepines [BZD]) dependence (DSM IV criteria) within 1 year of the study and lasting longer than 2 years, except for alcohol dependence;
4. . current pregnancy (as documented by pregnancy testing at screening or on the day of PET imaging study);
5. . current breast feeding;
6. . nicotine dependence;
7. . suicidal ideation or behavior;
8. . general MRI exclusion criteria, i.e. pacemakers, metals in the body;
9. . HIV (due to possible neuropsychiatric effects);
10. . Hepatitis B or C (due to possible neuropsychiatric effects);
11. . use of opioid medications within 2 weeks of the PET study;
12. . having an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participation in the study;
13. . seriously claustrophobic;
14. . blood donation within 8 weeks prior to the study;
15. . positive alcohol breathalyzer test;
16. . Abnormal thyroid test indicated by TSH < .15 mlU/L and/or T4 > 18 mcg/dL;
17. . Glucose > 200 mg/dL on two separate days.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Positron emission tomography/magnetic resonance imaging	Procedure: Positron emission tomography/magnetic resonance imaging; Positron emission tomography/magnetic resonance (PET/MR) imaging using 18-F-fluorodeoxyglucose (FDG) as radio tracer; Other Names: PET Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: NYU Langone Health

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: January 22, 2014
• First Submitted That Met QC Criteria: January 31, 2014
• First Posted (Estimate): February 3, 2014

Study Record Updates

• Last Update Posted (Estimate): March 3, 2016
• Last Update Submitted That Met QC Criteria: March 2, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Imaging; Neuroimaging; Trauma; Post-traumatic stress disorder (PTSD); F-18-fluorodeoxyglucose (FDG)
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: S13-00313