High-frequency vs. Low-frequency vs. Sham DMPFC-rTMS for Bulimia and Anorexia Nervosa

Not Applicable

Terminated

• Conditions: Bulimia Nervosa; Anorexia Nervosa
• Interventions: Device: High-frequency rTMS; Device: Sham rTMS; Device: Low-frequency rTMS

• Registration Number: NCT02702167
• Lead Sponsor: University Health Network, Toronto

Brief Summary

This trial will compare the efficacy and tolerability of 10 Hz vs. 1 Hz vs. sham repetitive transcranial magnetic stimulation targeting the dorsomedial prefrontal cortex, delivered once daily over 30 days, in patients with a diagnosis of bulimia or anorexia nervosa binge-purge subtype. The trial will include structural and functional MRI, and behavioral measures obtained before, during, and after treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2016-03-02
• Study First Posted: 2016-03-08
• Study Start: 2017-11-01
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-frequency rTMS	High-frequency rTMS	10 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks
Sham rTMS	Sham rTMS	Sham repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks
Low-frequency rTMS	Low-frequency rTMS	1 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks

Primary Outcome Measures

Name	Time	Method
Weekly Binge/Purge Frequency on Eating Disorder Examination (EDE)	Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment	Outcome measured by a change in weekly binge and purge episodes from baseline to 2 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A final score of 0 weekly binges and 0 weekly vomits is categorized as remission.

Secondary Outcome Measures

Name	Time	Method
Eating Disorder Inventory-3	Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment
Eating Disorder Examination Questionnaire (EDE-Q)	Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment

Trial Locations

Locations (1)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada