Neurofeedback of Amygdala Activity for Post-traumatic Stress Disorder (PTSD)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Yale University
- Enrollment
- 27
- Locations
- 4
- Primary Endpoint
- Change in Control Over the Amygdala
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Participants will be blind to group assignment (experimental feedback intervention or control feedback intervention). The outcome assessor will be blind to group assignment.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in Control Over the Amygdala
Time Frame: baseline; 30 day-day follow up
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
Secondary Outcomes
- Improvements in PTSD Symptoms(Baseline; 60-day follow-up)
- Number of Participants With Changes in Resting State Connectivity to the Amygdala(Baseline; 60 days follow up.)