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Phase I-II

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

  • Study HIC#:2000022668
  • Last Updated:07/15/2021

Brief Summary:

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.

  • Age18 years and older
  • GenderBoth
  • Start Date09/05/2018
  • End Date02/28/2022

Trial Purpose and Description

The primary purpose of this study is to investigate the efficacy of biofeedback (or neurofeedback ; “NF”) of real-time functional magnetic resonance imaging (rt-fMRI) data for reducing symptoms in patients with PTSD. The target mechanism for this intervention is control over amygdala activity following trauma recall. Namely, participants will be presented with rt-fMRI data that corresponds to amygdala activity in response to recalled trauma in order to help them improve control over this key region in the fear circuit. We hypothesize that improved control over the amygdala will reduce the core symptoms of PTSD and initiate a healthier clinical trajectory.

A secondary purpose of this study is to use fMRI as a method for 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 (2) examining how amygdala connectivity is related to both amygdala regulation and clinical symptoms.

Eligibility Criteria

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

Principal Investigator

Sub-Investigators

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