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

Not Applicable

Withdrawn

• Conditions: Anorexia Nervosa; Bulimia Nervosa; Eating Disorders
• Interventions: Device: Sham Transcranial Magnetic Stimulation; Device: Repetitive Transcranial Magnetic Stimulation

• Registration Number: NCT04061304
• Lead Sponsor: University of Manitoba

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-08-15
• Study First Posted: 2019-08-19
• Study Start: 2020-06-01
• Status Verified: 2021-03
• Primary Completion: 2021-03-19
• Study Completion: 2021-03-19
• Last Update Submitted: 2021-10-01
• Last Update Posted: 2021-10-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham rTMS (Anorexia Nervosa)	Sham Transcranial Magnetic Stimulation	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.
Active rTMS (Anorexia Nervosa)	Repetitive Transcranial Magnetic Stimulation	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
Active rTMS (Bulimia Nervosa)	Repetitive Transcranial Magnetic Stimulation	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
Sham rTMS (Bulimia Nervosa)	Sham Transcranial Magnetic 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.

Primary Outcome Measures

Name	Time	Method
Weekly Binge/Purge Frequency on Eating Disorder Examination	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.

Secondary Outcome Measures

Name	Time	Method
Change in Beck Anxiety Inventory (BAI)	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.
Change in Beck Depression Inventory (BDI)	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.