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

Phase 1

Completed

• Conditions: Bulimia Nervosa; Anorexia Nervosa
• Interventions: Device: Repetitive Transcranial Magnetic Stimulation

• Registration Number: NCT04409704
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-11
• Primary Completion: 2015-04-30
• Study Completion: 2015-12-07
• Status Verified: 2020-05
• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-05-26
• Last Update Submitted: 2020-05-26
• Study First Posted: 2020-06-01
• Last Update Posted: 2020-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
10 Hz	Repetitive Transcranial Magnetic Stimulation	10 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 4-6 weeks

Primary Outcome Measures

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