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

• Sponsor: University of Minnesota (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04220112
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 31
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Anorexia; Anorexia Nervosa	Procedure: Real-Time Functional Magnetic Resonance Imaging (RT-fMRI); Procedure: Sham Procedure	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: Comparing Real-time fMRI Neurofeedback Versus Sham for Altering Limbic and Eating Disturbances in Anorexia Nervosa
• Actual Study Start Date: Mar 1, 2020
• Actual Primary Completion Date: Jul 12, 2022
• Anticipated Study Completion Date: Sep 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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).

3. Test Meal Caloric Intake [2 months]

   Caloric consumption (in kilocalories) from a laboratory test meal

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• University of Minnesota

Investigators

• Principal Investigator: Ann Haynos, PhD, University of Minenesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT04220112
• Other Study ID Numbers: PSYCH-2019-28137
• First Posted: Jan 7, 2020
• Last Update Posted: Jul 13, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anorexia; Anorexia Nervosa

Study Results

No Results Posted as of Jul 13, 2022