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

NCT04220112 | Completed DMC

• 1 other identifier: PSYCH-2019-28137
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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?

Conditions

Anorexia; Anorexia Nervosa

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Test Meal Caloric Intake

  Caloric consumption (in kilocalories) from a laboratory test meal

  2 months

Study Arms (2)

Real Time Functional MRI (rt-fMRI)

EXPERIMENTAL

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

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

Sham

SHAM COMPARATOR

Sham-controlled group

Procedure: Sham Procedure

Interventions

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

RT-fMRI neurofeedback targeting down-regulation of the amygdala

Real Time Functional MRI (rt-fMRI)

Sham Procedure PROCEDURE

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

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Anorexia; Anorexia Nervosa

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding and Eating Disorders; Mental Disorders

Study Officials

• Ann Haynos, PhD

  University of Minenesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 7, 2020
• Study Start: March 1, 2020
• Primary Completion: July 31, 2022
• Study Completion: September 30, 2022
• Last Updated: December 1, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)