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

NCT ID: NCT04061304

Last Updated: 2021-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-03-19

Brief Summary

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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.

Detailed Description

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Conditions

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Eating Disorders Anorexia Nervosa Bulimia Nervosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

A non-invasive method of brain stimulation.

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

Group Type EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

A non-invasive method of brain stimulation.

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.

Group Type SHAM_COMPARATOR

Sham Transcranial Magnetic Stimulation

Intervention Type DEVICE

A device designed to look, sound, and feel like a real magnetic stimulation coil without actually stimulating the brain.

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.

Group Type SHAM_COMPARATOR

Sham Transcranial Magnetic Stimulation

Intervention Type DEVICE

A device designed to look, sound, and feel like a real magnetic stimulation coil without actually stimulating the brain.

Interventions

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Repetitive Transcranial Magnetic Stimulation

A non-invasive method of brain stimulation.

Intervention Type DEVICE

Sham Transcranial Magnetic Stimulation

A device designed to look, sound, and feel like a real magnetic stimulation coil without actually stimulating the brain.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mandana Modirrousta, MD PhD FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Other Identifiers

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HS22828 (B2019:033)

Identifier Type: -

Identifier Source: org_study_id

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