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

Primary Purpose

Bulimia Nervosa, Anorexia Nervosa

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bulimia Nervosa focused on measuring Eating Disorders, rTMS, Anorexia, Bulimia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    10 Hz

    Arm Description

    10 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 4-6 weeks

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 21, 2020
    Last Updated
    May 26, 2020
    Sponsor
    University Health Network, Toronto
    Collaborators
    Klarman Family Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04409704
    Brief Title
    Repetitive Transcranial Magnetic Stimulation of the DMPFC for Anorexia and Bulimia: an Open-Label Case Series
    Official Title
    Repetitive Transcranial Magnetic Stimulation of the Dorsomedial Prefrontal Cortex as a Treatment for Anorexia Nervosa and Bulimia Nervosa: An Open-Label Case Series
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    December 11, 2011 (Actual)
    Primary Completion Date
    April 30, 2015 (Actual)
    Study Completion Date
    December 7, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Health Network, Toronto
    Collaborators
    Klarman Family Foundation

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bulimia Nervosa, Anorexia Nervosa
    Keywords
    Eating Disorders, rTMS, Anorexia, Bulimia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    10 Hz
    Arm Type
    Experimental
    Arm Description
    10 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 4-6 weeks
    Intervention Type
    Device
    Intervention Name(s)
    Repetitive Transcranial Magnetic Stimulation
    Other Intervention Name(s)
    High-frequency rTMS, Magventure DB80 Coil
    Intervention Description
    10 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week, 20-30 sessions.
    Primary Outcome Measure Information:
    Title
    Eating Disorder Examination (EDE)
    Description
    Weekly Binge/Purge Frequency on Eating Disorder Examination (EDE), a semi-structured interview assessing the full range of the specific psychopathology of eating disorders.
    Time Frame
    Change from baseline to 1 week post-treatment completion.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: Past or current neurological illness Comorbid schizophrenia Current suicidal intent or plan Contraindications to MRI or rTMS (e.g., metallic implants/foreign bodies) Pregnancy.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jonathan Downar, MD
    Organizational Affiliation
    University Health Network, Toronto
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Blake Woodside, MD
    Organizational Affiliation
    University Health Network, Toronto
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33865456
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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