Neurofeedback of Amygdala Activity for Post-traumatic Stress Disorder



Status:Recruiting
Conditions:Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:7/28/2018
Start Date:June 1, 2018
End Date:June 30, 2023
Contact:Charles Gordon, MA
Email:charles.gordon@yale.edu
Phone:(203) 937-4760

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

Neurofeedback of Amygdala Activity for Post-traumatic Stress Disorder (PTSD)

The primary purpose of this study is to investigate the efficacy of neurofeedback (NF) of
real-time functional magnetic resonance imaging (rt-fMRI) data of the amygdala with regards
to the reduction of post-traumatic stress disorder (PTSD) symptoms.

A secondary purpose of this study is to use fMRI as a method of investigating brain function
in individuals with PTSD. This study approach provides a tool for probing the neurobiology of
PTSD by (1) testing the critical role of the amygdala in this disorder, and by (2) examining
how amygdala connectivity is related to both amygdala regulation and clinical symptoms.

In pursuit of the overarching goals of this study, the investigators aim to:

- determine if an experimental feedback intervention increases control over the region of
interest (the amygdala) more than a control feedback intervention in which participants
receive feedback that is unassociated with their PTSD symptoms.

- determine if an experimental feedback intervention results in clinical improvements in
PTSD symptoms relative to a control feedback intervention, and examine whether these
improvements correlate with improved control over the amygdala.

- determine if an experimental feedback intervention results in changes in resting state
connectivity to the amygdala, and whether these changes correlate with symptom
improvement and an improved ability to regulate the amygdala.

Inclusion Criteria

- Ages 18 and up

- Diagnosis of chronic PTSD, as established by the Clinician Administered PTSD Scale for
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V; CAPS-5)

- Ability to give signed, informed consent in English

- Normal or corrected-to-normal vision

- Participants who are on a stable dose of selective serotonin reuptake inhibitor (SSRI)
antidepressants for 2 months (3 months if they are on sertraline), or who have been
un-medicated for at least 2 months, will be allowed to participate in this study

- At the time of recruitment, patients must have no intention of changing their
medication or psychotherapy during the 2.5-month period of the intervention

- Research group must be able to identify a trauma-related target region in or
immediately adjacent to the amygdala

Exclusion Criteria

- Any primary psychiatric diagnosis of a current major mood disorder, psychotic
disorder, autism, mental retardation, or DSM-5 substance use disorder of mild or
greater severity (2 or more symptoms) in the past 30 days. Comorbid mood and anxiety
disorders will be permitted if they are not the primary focus of clinical attention

- Any history of psychosis or mania

- Active suicidality within past year, or history of suicide attempt in past 2 years

- Any contraindication to MRI scanning (severe claustrophobia, ferromagnetic metal in
body, etc.)

- Pregnancy

- Any unstable medical or neurological condition

- Any history of severe past drug dependence (i.e., a focus of clinical attention or a
cause of substantial social or occupational difficulty)

- Any history of brain surgery, of penetrating, neurovascular, infectious, or other
major brain injury, of epilepsy, or of other major neurological abnormality (including
a history of traumatic brain injury [TBI] with loss of consciousness for more than 24
hours or posttraumatic amnesia for more than 7 days)

- Significant hearing loss or severe sensory impairment

- Any psychotropic medication other than a stable dose of selective serotonin reuptake
inhibitors (SSRIs)

- Any change in accepted psychotropic medication within the past 2 months

- Active engagement in cognitive-behavioral therapy or any evidence-based PTSD
psychotherapy (Cognitive Processing Therapy [CPT], Prolonged Exposure [PE], Eye
Movement Desensitization and Reprocessing [EMDR]) initiated within the past 3 months;
continuation of established maintenance supportive therapy will be permitted

- Enrollment in another research study testing an experimental/clinical/behavioral
intervention intended to affect symptoms initiated within the last 2 months, or
intended enrollment within the next 2.5 months
We found this trial at
2
sites
West Haven, Connecticut 06516
Principal Investigator: Ilan Harpaz-Rotem, PhD
Phone: 203-937-4760
?
mi
from
West Haven, CT
Click here to add this to my saved trials
New Haven, Connecticut 06520
Principal Investigator: Michelle Hampson, PhD
Phone: 203-737-6055
?
mi
from
New Haven, CT
Click here to add this to my saved trials