Clinical trial NCT03574974: Neurofeedback of Amygdala Activity for Post-traumatic Stress Disorder
Official title: Neurofeedback of Amygdala Activity for Post-traumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Keywords: PTSD
Neurofeedback
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: VA Connecticut Healthcare System
name: National Institute of Mental Health (NIMH)
First posted: 2018-07-02
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will receive either an experimental feedback intervention or a control feedback intervention. Participants who receive the control feedback intervention will be offered to return to receive the experimental feedback intervention upon completion of the study.
Primary purpose: TREATMENT

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.

Detailed description: 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.

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

Primary outcomes:
measure: Change in Control Over the Amygdala
timeFrame: baseline; 30 day-day follow up
Secondary outcomes:
measure: Improvements in PTSD Symptoms
timeFrame: Baseline; 30-day follow-up
measure: Improvements in PTSD Symptoms
timeFrame: Baseline; 60-day follow-up
measure: Number of Participants With Changes in Resting State Connectivity to the Amygdala
timeFrame: Baseline; 60 days follow up.
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: West Haven
country: United States
facility: VA Connecticut Healthcare System - West Haven Campus
state: Connecticut
Study officials:
affiliation: Yale University School of Medicine, VA
name: Ilan Harpaz-Rotem, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Michelle Hampson, PhD
role: PRINCIPAL_INVESTIGATOR
References: