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

NCT ID: NCT04220112

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2022-09-30

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.

Conditions

Anorexia; Anorexia Nervosa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Real Time Functional MRI (rt-fMRI)

Real-time fMRI (rt-fMRI) neurofeedback (focused on amygdala down-regulation) intervention

Group Type: EXPERIMENTAL

Real-Time Functional Magnetic Resonance Imaging (RT-fMRI)

Intervention Type: PROCEDURE

RT-fMRI neurofeedback targeting down-regulation of the amygdala

Sham

Sham-controlled group

Group Type: SHAM_COMPARATOR

Sham Procedure

Intervention Type: PROCEDURE

RT-fMRI with feedback non-contingently tied to their activation patterns (activation patterns from a prior participant)

Interventions

Real-Time Functional Magnetic Resonance Imaging (RT-fMRI)

RT-fMRI neurofeedback targeting down-regulation of the amygdala

Intervention Type: PROCEDURE

Sham Procedure

RT-fMRI with feedback non-contingently tied to their activation patterns (activation patterns from a prior participant)

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ann Haynos, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minenesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

PSYCH-2019-28137

Identifier Type: -

Identifier Source: org_study_id