Repetitive Transcranial Magnetic Stimulation of the DMPFC for Anorexia and Bulimia: an Open-Label Case Series

Repetitive Transcranial Magnetic Stimulation of the Dorsomedial Prefrontal Cortex as a Treatment for Anorexia Nervosa and Bulimia Nervosa: An Open-Label Case Series

This project proposes to perform a pilot study of fMRI targeted Dorsomedial Prefrontal Cortex repetitive transcranial magnetic stimulation (DMPFC-rTMS) on individuals diagnosed with Bulimia Nervosa (BN) and Anorexia Nervosa (AN). The DMFPC is a novel target for rTMS, is heavily implicated in the regulation of mood and affect, and has been suggested to be involved in AN, BN, major depression, OCD, and PTSD. Improved function in this area might lead to reduced AN and BN symptoms, such as bingeing, purging, and over-activity, perhaps by improved regulation of mood and affect. Improvements in important areas of comorbidity might allow for better response to intensive treatment for AN and BN, and reduce relapse rates after such treatment. The DMPFC may be a more appropriate target for compared to the Dorsolateral Prefrontal Cortex (DLPFC), which has typically been the focus of stimulation in the past. Our initial preliminary pilot work has noted unexpected and significant improvements in some core ED symptoms (bingeing and purging) and in important areas of comorbidity (OCD and PTSD), along with expected improvements in mood. These changes have allowed some treatment resistant patients to either complete intensive treatment or be successful in maintaining their progress post intensive treatment. Subjects will receive up to 30 sessions of bilateral DMPFC-rTMS. Response will be evaluated clinically, via psychometric measures, and pre and post fMRI.

Study Overview

• Status: Completed
• Conditions: Anorexia Nervosa; Bulimia Nervosa
• Intervention / Treatment: Device: Repetitive Transcranial Magnetic Stimulation

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients will be included if they:

• Are voluntary and competent to consent to treatment.
• Have met DSM-5 diagnostic criteria for Anorexia Nervosa or Bulimia Nervosa, over the last 6 months at minimum

Exclusion Criteria:

Patients will be excluded if they have:

1. Past or current neurological illness
2. Comorbid schizophrenia
3. Current suicidal intent or plan
4. Contraindications to MRI or rTMS (e.g., metallic implants/foreign bodies)
5. Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10 Hz; 10 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 4-6 weeks	Device: Repetitive Transcranial Magnetic Stimulation; 10 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week, 20-30 sessions.; Other Names: High-frequency rTMS; Magventure DB80 Coil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eating Disorder Examination (EDE)	Weekly Binge/Purge Frequency on Eating Disorder Examination (EDE), a semi-structured interview assessing the full range of the specific psychopathology of eating disorders.	Change from baseline to 1 week post-treatment completion.

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Klarman Family Foundation
• Investigators: Principal Investigator: Jonathan Downar, MD, University Health Network, Toronto; Principal Investigator: Blake Woodside, MD, University Health Network, Toronto

Publications and helpful links

General Publications

• Woodside DB, Dunlop K, Sathi C, Lam E, McDonald B, Downar J. A pilot trial of repetitive transcranial magnetic stimulation of the dorsomedial prefrontal cortex in anorexia nervosa: resting fMRI correlates of response. J Eat Disord. 2021 Apr 17;9(1):52. doi: 10.1186/s40337-021-00411-x.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2011
• Primary Completion (Actual): April 30, 2015
• Study Completion (Actual): December 7, 2015

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 26, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: rTMS; Anorexia; Bulimia; Eating Disorders
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Hyperphagia; Anorexia; Anorexia Nervosa; Bulimia; Bulimia Nervosa
• Other Study ID Numbers: 11-0771

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No