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A Clinical Trial Into the Efficacy of rTMS Treatment for Treating Anorexia Nervosa and Bulimia Nervosa

Primary Purpose

Eating Disorders, Anorexia Nervosa, Bulimia Nervosa

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Sham Transcranial Magnetic Stimulation
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders focused on measuring rTMS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Confirmed diagnosis of Anorexia Nervosa or Bulimia Nervosa, must pass rTMS screening questionnaire

Exclusion Criteria:

  • Diagnosis of another psychiatric disorder, except MDD.
  • Any rTMS counter-indications:
  • History of seizures
  • Metal in head
  • Currently pregnant
  • Having received rTMS for any reason in the past as this would interfere with participant blinding.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Sham Comparator

    Sham Comparator

    Arm Label

    Active rTMS (Anorexia Nervosa)

    Active rTMS (Bulimia Nervosa)

    Sham rTMS (Anorexia Nervosa)

    Sham rTMS (Bulimia Nervosa)

    Arm Description

    Patients in this arm will receive 40 sessions of active rTMS. Every day, the first session of rTMS for both groups will be applied to the left DLPFC using intermittent Theta Burst Stimulation (iTBS). For the second session each day the patients in the anorexia group will receive low-frequency treatment (1 Hz, 60 second cycles, 30 second inter-train interval, 20 trains, 1200 total pulses) at 120% of the resting motor threshold to the orbitofrontal cortex

    Patients in this arm will receive 40 sessions of active rTMS. Every day, the first session of rTMS for both groups will be applied to the left DLPFC using intermittent Theta Burst Stimulation (iTBS). For the second session each day the patients in the bulimia group will receive high-frequency (10 Hz, 5 second cycles, 50 pulses, 25 second inter-train interval, 60 trains, 3000 total) at 120% of the resting motor threshold treatment to the left dorsomedial prefrontal cortex

    Patients in this arm will receive 40 sessions of sham rTMS. They will be set up the same as the active Anorexia Nervosa group however their will be no actual brain stimulation.

    Patients in this arm will receive 40 sessions of sham rTMS. They will be set up the same as the active Bulimia Nervosa group however their will be no actual brain stimulation.

    Outcomes

    Primary Outcome Measures

    Weekly Binge/Purge Frequency on Eating Disorder Examination
    Outcome measured by change of binge/purge episodes from baseline to the end of treatment. If the participant has a final score of 0 binges and 0 purges they will be considered in remission. A 50% improvement will be defined as a response to the rTMS.

    Secondary Outcome Measures

    Change in Beck Anxiety Inventory (BAI)
    Outcome range: 0-63, with higher scores reflecting higher levels of anxiety. A total of 21 questions are summed for a total score out of 63.
    Change in Beck Depression Inventory (BDI)
    Outcome range: 0-63, with higher scores reflecting higher levels of depression. A total of 21 questions are summed for a total score out of 63.

    Full Information

    First Posted
    July 2, 2019
    Last Updated
    October 1, 2021
    Sponsor
    University of Manitoba
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04061304
    Brief Title
    A Clinical Trial Into the Efficacy of rTMS Treatment for Treating Anorexia Nervosa and Bulimia Nervosa
    Official Title
    A Clinical Trial Into the Efficacy of rTMS Treatment for Treating Anorexia Nervosa and Bulimia Nervosa
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Challenges with funding acquisition prevented study commencement.
    Study Start Date
    June 1, 2020 (Actual)
    Primary Completion Date
    March 19, 2021 (Actual)
    Study Completion Date
    March 19, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Manitoba

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a pilot study to test the efficacy of repetitive transcranial magnetic stimulation (rTMS) in treating individuals with Anorexia Nervosa and Bulimia Nervosa. The main objective of this study is to determine the short and long-term efficacy of repetitive transcranial magnetic stimulation (rTMS) in reducing eating disorder symptoms (i.e. binging, purging, restricting, intense fear of gaining wait, etc;) in Anorexia Nervosa and Bulimia Nervosa. The investigators will also be comparing the brain activity patterns of individuals with Anorexia Nervosa and Bulimia Nervosa to healthy controls using electroencephalography (EEG). Further, the investigators would like to examine if the activation patterns in these patients change after receiving rTMS.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Active rTMS (Anorexia Nervosa)
    Arm Type
    Experimental
    Arm Description
    Patients in this arm will receive 40 sessions of active rTMS. Every day, the first session of rTMS for both groups will be applied to the left DLPFC using intermittent Theta Burst Stimulation (iTBS). For the second session each day the patients in the anorexia group will receive low-frequency treatment (1 Hz, 60 second cycles, 30 second inter-train interval, 20 trains, 1200 total pulses) at 120% of the resting motor threshold to the orbitofrontal cortex
    Arm Title
    Active rTMS (Bulimia Nervosa)
    Arm Type
    Experimental
    Arm Description
    Patients in this arm will receive 40 sessions of active rTMS. Every day, the first session of rTMS for both groups will be applied to the left DLPFC using intermittent Theta Burst Stimulation (iTBS). For the second session each day the patients in the bulimia group will receive high-frequency (10 Hz, 5 second cycles, 50 pulses, 25 second inter-train interval, 60 trains, 3000 total) at 120% of the resting motor threshold treatment to the left dorsomedial prefrontal cortex
    Arm Title
    Sham rTMS (Anorexia Nervosa)
    Arm Type
    Sham Comparator
    Arm Description
    Patients in this arm will receive 40 sessions of sham rTMS. They will be set up the same as the active Anorexia Nervosa group however their will be no actual brain stimulation.
    Arm Title
    Sham rTMS (Bulimia Nervosa)
    Arm Type
    Sham Comparator
    Arm Description
    Patients in this arm will receive 40 sessions of sham rTMS. They will be set up the same as the active Bulimia Nervosa group however their will be no actual brain stimulation.
    Intervention Type
    Device
    Intervention Name(s)
    Repetitive Transcranial Magnetic Stimulation
    Intervention Description
    A non-invasive method of brain stimulation.
    Intervention Type
    Device
    Intervention Name(s)
    Sham Transcranial Magnetic Stimulation
    Intervention Description
    A device designed to look, sound, and feel like a real magnetic stimulation coil without actually stimulating the brain.
    Primary Outcome Measure Information:
    Title
    Weekly Binge/Purge Frequency on Eating Disorder Examination
    Description
    Outcome measured by change of binge/purge episodes from baseline to the end of treatment. If the participant has a final score of 0 binges and 0 purges they will be considered in remission. A 50% improvement will be defined as a response to the rTMS.
    Time Frame
    baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment.
    Secondary Outcome Measure Information:
    Title
    Change in Beck Anxiety Inventory (BAI)
    Description
    Outcome range: 0-63, with higher scores reflecting higher levels of anxiety. A total of 21 questions are summed for a total score out of 63.
    Time Frame
    baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment.
    Title
    Change in Beck Depression Inventory (BDI)
    Description
    Outcome range: 0-63, with higher scores reflecting higher levels of depression. A total of 21 questions are summed for a total score out of 63.
    Time Frame
    baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Confirmed diagnosis of Anorexia Nervosa or Bulimia Nervosa, must pass rTMS screening questionnaire Exclusion Criteria: Diagnosis of another psychiatric disorder, except MDD. Any rTMS counter-indications: History of seizures Metal in head Currently pregnant Having received rTMS for any reason in the past as this would interfere with participant blinding.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mandana Modirrousta, MD PhD FRCPC
    Organizational Affiliation
    University of Manitoba
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    A Clinical Trial Into the Efficacy of rTMS Treatment for Treating Anorexia Nervosa and Bulimia Nervosa

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