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

University of Manitoba

Status: Withdrawn

Conditions: Bulimia Nervosa; Eating Disorders; Anorexia Nervosa

Treatments: Device: Sham Transcranial Magnetic Stimulation; Device: Repetitive Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04061304

HS22828 (B2019:033)

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 4 patient groups

Active rTMS (Anorexia Nervosa)

Experimental group

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

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation

Active rTMS (Bulimia Nervosa)

Experimental group

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

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation

Sham rTMS (Anorexia Nervosa)

Sham Comparator group

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.

Treatment:

Device: Sham Transcranial Magnetic Stimulation

Sham rTMS (Bulimia Nervosa)

Sham Comparator group

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.

Treatment:

Device: Sham Transcranial Magnetic Stimulation