Neurofeedback of Amygdala Activity for Post-traumatic Stress Disorder

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.

Conditions

• Post-Traumatic Stress Disorder

Interventions

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.

DEVICE

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.

Sponsors & Collaborators

• VA Connecticut Healthcare System

  collaborator FED

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Yale University

  lead OTHER

Principal Investigators

• Ilan Harpaz-Rotem, PhD · Yale University School of Medicine, VA

• Michelle Hampson, PhD · Yale University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-01

Primary Completion

2022-03-08

Completion

2022-03-08

Countries

• United States

Study Locations