Neurofeedback of Amygdala Activity for Post-traumatic Stress Disorder

Post-Traumatic Stress Disorder Clinical Trial

— PTSD  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03574974
• Other study ID #: 2000022668
• Secondary ID: 1R61MH115110-01A
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: March 8, 2022

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: March 8, 2022
• Est. primary completion date: March 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Device:
• Experimental Feedback
Feedback is presented in the form of a line graph that is updated every 2 seconds throughout the scan to indicate activity in the target area. A red diamond will indicate periods of symptom provocation, during which participants are exposed to symptom-provoking auditory stimuli in the form of personalized trauma scripts and sound clips. A blue arrow will indicate periods of down-regulation, where participants will try to bring the feedback line down as much as possible (by trying to decrease their fear/anxiety). The investigators believe that this feedback may help participants learn to control their PTSD symptoms. Participants will attend a total of 18 feedback scans over the course of 3 sessions.
• Control Feedback
Feedback is presented in the form of a line graph that is updated every 2 seconds throughout the scan to indicate activity in the target area. A red diamond will indicate periods of symptom provocation, during which participants are exposed to symptom-provoking auditory stimuli in the form of personalized trauma scripts and sound clips. A blue arrow will indicate periods of down-regulation, where participants will try to bring the feedback line down as much as possible (by trying to decrease their fear/anxiety). The investigators do not believe this feedback can help participants' PTSD symptoms. Participants will attend a total of 18 feedback scans over the course of 3 sessions.

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut
United States	VA Connecticut Healthcare System - West Haven Campus	West Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	National Institute of Mental Health (NIMH), VA Connecticut Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Control Over the Amygdala	Control over the amygdala will be defined as the change in the blood-oxygen-level dependent (BOLD) signal in the target area (an individually-localized region of interest (ROI) in the amygdala) during down-regulation blocks following symptom provocation relative to rest. Investigators will assess the magnitude of change in control over the amygdala to trauma reminders from baseline to 30-day post treatment follow-up. This measure is based on beta values, which are unitless	baseline; 30 day-day follow up
Secondary	Improvements in PTSD Symptoms	Clinical improvement will be defined as the change from baseline at the post-intervention assessments (based on the past-month Clinician-Administered PTSD scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V ) [CAPS-5]). Score ranges from 0 - no PTSD symptoms to a maximum of 80. Higher score is associated with increase severity of PTSD. A change in CAPS score of more than 5 points over the course of treatment is considered a meaningful change and a change of 10 point or more is considered to be a clinically meaningful change.	Baseline; 30-day follow-up
Secondary	Improvements in PTSD Symptoms	Clinical improvement will be defined as the change from baseline at the post-intervention assessments (based on the past-month Clinician-Administered PTSD scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V ) [CAPS-5]). Score ranges from 0 - no PTSD symptoms to a maximum of 80. Higher score is associated with increase severity of PTSD. A change in CAPS score of more than 5 points over the course of treatment is considered a meaningful change and a change of 10 point or more is considered to be a clinically meaningful change.	Baseline; 60-day follow-up
Secondary	Number of Participants With Changes in Resting State Connectivity to the Amygdala	The number of participants with a significant whole brain change in seed region connectivity to the amygdala from pre- to post-intervention will be assessed in the blood-oxygen-level dependent (BOLD) signal collected during resting state runs.	Baseline; 60 days follow up.