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

October 1, 2021 updated by: University of Manitoba

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active rTMS (Anorexia Nervosa)

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
Device: Repetitive Transcranial Magnetic Stimulation
A non-invasive method of brain stimulation.
Experimental: Active rTMS (Bulimia Nervosa)

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
Device: Repetitive Transcranial Magnetic Stimulation
A non-invasive method of brain stimulation.
Sham Comparator: Sham rTMS (Anorexia Nervosa)
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.
Device: Sham Transcranial Magnetic Stimulation
A device designed to look, sound, and feel like a real magnetic stimulation coil without actually stimulating the brain.
Sham Comparator: Sham rTMS (Bulimia Nervosa)
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.
Device: Sham Transcranial Magnetic Stimulation
A device designed to look, sound, and feel like a real magnetic stimulation coil without actually stimulating the brain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weekly Binge/Purge Frequency on Eating Disorder Examination
Time Frame: baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment.
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.
baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Beck Anxiety Inventory (BAI)
Time Frame: baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment.
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.
baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment.
Change in Beck Depression Inventory (BDI)
Time Frame: baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment.
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.
baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

March 19, 2021

Study Completion (Actual)

March 19, 2021

Study Registration Dates

First Submitted

July 2, 2019

First Submitted That Met QC Criteria

August 15, 2019

First Posted (Actual)

August 19, 2019

Study Record Updates

Last Update Posted (Actual)

October 8, 2021

Last Update Submitted That Met QC Criteria

October 1, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS22828 (B2019:033)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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