Comparing Real-time fMRI Neurofeedback Versus Sham for Altering Limbic and Eating Disturbances in Anorexia Nervosa

Study Overview
=================
Brief Summary
-----------------
The goal of the purposed research is to extend prior work (STUDY00003758: Real-time fMRI Neurofeedback to Alter Limbic Disturbances in Anorexia Nervosa) on real-time fMRI (rt-fMRI) neurofeedback (focused on amygdala down-regulation) as an innovative neurocircuitry-targeted intervention for anorexia nervosa (AN). This project will include randomization to rt-fMRI or a sham controlled group to answer the following important unresolved question: Does a patient-led procedure aimed at altering brain activity impact limbic circuit function and key eating disorder and psychiatric symptoms in AN above the effect of a matched, but non-targeted sham condition?

Detailed Description
-----------------
Aim 1: Establish that rt-fMRI neurofeedback of limbic activity can correct neural disturbances in AN. Hypothesis 1: Compared to the sham group, the amygdala neurofeedback group will show reduced amygdala activation to aversive images, which will increase with repeated training. This effect will generalize to non-neurofeedback test runs. Hypothesis 2: Compared to the sham group, the amygdala neurofeedback group will exhibit enhanced task and resting amygdala-prefrontal cortex (PFC) connectivity, which will increase with repeated training. Enhanced amygdala-PFC connectivity will be associated with less amygdala reactivity to aversive images during the emotion regulation task. Aim 2: Identify the impact of rt-fMRI neurofeedback targeting limbic functioning on symptoms of AN. Hypothesis 1: Compared to the sham group, the amygdala neurofeedback group will exhibit improvements in self-reported emotion regulation and eating disorder symptoms over the study visits. Hypothesis 2: Compared to the sham group, the amygdala neurofeedback group will engage in less restrictive eating (i.e., will consume more calories) at a post-training test meal. Hypothesis 3: Across groups, decreased aversive amygdala reactivity and enhanced amygdala-PFC connectivity will predict reduced emotion dysregulation and eating disorder symptoms, and less restriction.

Official Title
-----------------
Comparing Real-time fMRI Neurofeedback Versus Sham for Altering Limbic and Eating Disturbances in Anorexia Nervosa

Conditions
-----------------
Anorexia, Anorexia Nervosa

Intervention / Treatment
-----------------
* Procedure: Real-Time Functional Magnetic Resonance Imaging (RT-fMRI)
* Procedure: Sham Procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-5 diagnosis of AN, with the exception of body image disturbance and intense fear of weight gain Ability to read and speak in English Right-handed Exclusion Criteria: Medical instability or current pregnancy (self-reported) Acute suicidality, current substance use disorder, psychosis, or mania Contraindication for fMRI as determined by CMRR safety screening standards History of neurological disorder/injury (e.g., stroke; head injury with > 10 minutes loss of consciousness)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real Time Functional MRI (rt-fMRI)<br>Real-time fMRI (rt-fMRI) neurofeedback (focused on amygdala down-regulation) intervention | Procedure: Real-Time Functional Magnetic Resonance Imaging (RT-fMRI)<br>* RT-fMRI neurofeedback targeting down-regulation of the amygdala<br>|
| Sham Comparator: Sham<br>Sham-controlled group | Procedure: Sham Procedure<br>* RT-fMRI with feedback non-contingently tied to their activation patterns (activation patterns from a prior participant)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Eating Disorder Symptoms Scale (CHEDS) | CHEDS is a 35-item self-report measure designed to assess eating disorder symptom changes over a short-term (i.e. weekly) time span. Items are presented using a Likert response format in which symptoms are rated from 0 (never) to 4 (always) during the past week. Total score is a sum of the 35 item scores. | 2 months | 
| Change in Body Mass Index (BMI) | Change in body mass index (BMI) from baseline to end (2 months). BMI is calculated as body weight (in kg) divided by height (in cm) squared. BMI is reported in kg/(cm^2). | 2 months | 
| Test Meal Caloric Intake | Caloric consumption (in kilocalories) from a laboratory test meal | 2 months |