Clinical trial NCT04220112: Comparing Real-time fMRI Neurofeedback Versus Sham for Altering Limbic and Eating Disturbances in Anorexia Nervosa
Official title: Comparing Real-time fMRI Neurofeedback Versus Sham for Altering Limbic and Eating Disturbances in Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia
Anorexia Nervosa
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Change in Eating Disorder Symptoms Scale (CHEDS)
timeFrame: 2 months
measure: Change in Body Mass Index (BMI)
timeFrame: 2 months
measure: Test Meal Caloric Intake
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minenesota
name: Ann Haynos, PhD
role: PRINCIPAL_INVESTIGATOR
References: