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

Anorexia Nervosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04220112
• Other study ID #: PSYCH-2019-28137
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 30, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Procedure:
• Real-Time Functional Magnetic Resonance Imaging (RT-fMRI)
RT-fMRI neurofeedback targeting down-regulation of the amygdala
• Sham Procedure
RT-fMRI with feedback non-contingently tied to their activation patterns (activation patterns from a prior participant)

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Test Meal Caloric Intake	Caloric consumption (in kilocalories) from a laboratory test meal	2 months