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

Not Applicable

Completed

• Conditions: Anorexia Nervosa; Anorexia
• Interventions: Procedure: Real-Time Functional Magnetic Resonance Imaging (RT-fMRI); Procedure: Sham Procedure

• Registration Number: NCT04220112
• Lead Sponsor: University of Minnesota

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-01-03
• Study First Submitted QC: 2020-01-03
• Study First Posted: 2020-01-07
• Study Start: 2020-03-01
• Primary Completion: 2022-07-31
• Study Completion: 2022-09-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-29
• Last Update Posted: 2022-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real Time Functional MRI (rt-fMRI)	Real-Time Functional Magnetic Resonance Imaging (RT-fMRI)	Real-time fMRI (rt-fMRI) neurofeedback (focused on amygdala down-regulation) intervention
Sham	Sham Procedure	Sham-controlled group

Primary Outcome Measures

Name	Time	Method
Test Meal Caloric Intake	2 months	Caloric consumption (in kilocalories) from a laboratory test meal
Change in Eating Disorder Symptoms Scale (CHEDS)	2 months	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.
Change in Body Mass Index (BMI)	2 months	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).

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States