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COVID-19 pandemic restrictions.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-frequency rTMS | Experimental | 10 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks |
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| Low-frequency rTMS | Experimental | 1 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks |
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| Sham rTMS | Sham Comparator | Sham repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-frequency rTMS | Device | 10 Hz active stimulation, once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Weekly Binge/Purge Frequency on Eating Disorder Examination (EDE) | 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. | Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Resting-state functional MRI | 10 min resting-state functional MRI acquisition at 3T | 1 week pre- and 1 week post-intervention |
Inclusion Criteria (Patient):
Exclusion Criteria (Patient):
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Downar, MD PhD | University Health Network, Toronto | Principal Investigator |
| Blake Woodside, MD FRCPC | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Western Hospital | Toronto | Ontario | M5T2S8 | Canada |
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| ID | Term |
|---|---|
| D052018 | Bulimia Nervosa |
| D000856 | Anorexia Nervosa |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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| Low-frequency rTMS | Device | 1 Hz active stimulation, once daily |
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| Sham rTMS | Device | Sham stimulation, once daily |
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