Functional Brain Imaging in PTSD

Trauma Clinical Trial

Official title:

Functional Brain Imaging in PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02053532
• Other study ID #: S13-00313
• Status: Completed
• Phase: N/A
• First received: January 22, 2014
• Last updated: March 2, 2016
• Start date: May 2013
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Post-traumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Trauma

Intervention

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

Locations

Country	Name	City	State
United States	NYU School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No