Comparing Real-time fMRI Neurofeedback Versus Sham for Altering Limbic and Eating Disturbances in Anorexia Nervosa
Primary Purpose
Anorexia, Anorexia Nervosa
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Real-Time Functional Magnetic Resonance Imaging (RT-fMRI)
Sham Procedure
Sponsored by
About this trial
This is an interventional health services research trial for Anorexia
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)
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Real Time Functional MRI (rt-fMRI)
Sham
Arm Description
Real-time fMRI (rt-fMRI) neurofeedback (focused on amygdala down-regulation) intervention
Sham-controlled group
Outcomes
Primary Outcome Measures
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.
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).
Test Meal Caloric Intake
Caloric consumption (in kilocalories) from a laboratory test meal
Secondary Outcome Measures
Full Information
NCT ID
NCT04220112
First Posted
January 3, 2020
Last Updated
November 29, 2022
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT04220112
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia, Anorexia Nervosa
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Real Time Functional MRI (rt-fMRI)
Arm Type
Experimental
Arm Description
Real-time fMRI (rt-fMRI) neurofeedback (focused on amygdala down-regulation) intervention
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Sham-controlled group
Intervention Type
Procedure
Intervention Name(s)
Real-Time Functional Magnetic Resonance Imaging (RT-fMRI)
Intervention Description
RT-fMRI neurofeedback targeting down-regulation of the amygdala
Intervention Type
Procedure
Intervention Name(s)
Sham Procedure
Intervention Description
RT-fMRI with feedback non-contingently tied to their activation patterns (activation patterns from a prior participant)
Primary Outcome Measure Information:
Title
Change in Eating Disorder Symptoms Scale (CHEDS)
Description
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.
Time Frame
2 months
Title
Change in Body Mass Index (BMI)
Description
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).
Time Frame
2 months
Title
Test Meal Caloric Intake
Description
Caloric consumption (in kilocalories) from a laboratory test meal
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Haynos, PhD
Organizational Affiliation
University of Minenesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparing Real-time fMRI Neurofeedback Versus Sham for Altering Limbic and Eating Disturbances in Anorexia Nervosa
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