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

Study Overview
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Brief Summary
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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.

Official Title
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The Dorsomedial Prefrontal Cortex as a Target in Treatment-resistant Bulimia Nervosa and Anorexia Nervosa: Investigating Target Engagement, Dosing, Reliability and Duration of Effect Using rTMS, fMRI, and a Sham Controlled Arm

Conditions
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Bulimia Nervosa, Anorexia Nervosa

Intervention / Treatment
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* Device: High-frequency rTMS
* Device: Low-frequency rTMS
* Device: Sham rTMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Patient): Voluntary and Competent to Consent MINI confirmed Diagnosis of Bulimia Nervosa OR Anorexia Nervosa, Binge/Purge subtype Outpatient Between the ages of 18-65 Have had no increase or initiation of any psychotropic medication in the last 4 weeks prior to screening Must adhere to research schedule. Pass the TMS Safety Screening Questionnaire. Failed to achieve a clinical response to at least one pharmacotherapy or behavioral treatment in the current episode. Exclusion Criteria (Patient): Have a concomitant major unstable medical illness, cardiac pacemaker or implanted medical pump Have active suicidal intent Are pregnant Have a lifetime MINI diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms Have a MINI diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia assessed by a study investigator to be primary and causing greater impairment than the ED Have received rTMS for any previous indication due to the potential compromise of subject blinding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-frequency rTMS<br>10 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks | Device: High-frequency rTMS<br>* 10 Hz active stimulation, once daily<br>* Other names: Magventure Cool DB80 Active/Placebo Coil;|
| Experimental: Low-frequency rTMS<br>1 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks | Device: Low-frequency rTMS<br>* 1 Hz active stimulation, once daily<br>* Other names: Magventure Cool DB80 Active/Placebo Coil;|
| Sham Comparator: Sham rTMS<br>Sham repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks | Device: Sham rTMS<br>* Sham stimulation, once daily<br>* Other names: Magventure Cool DB80 Active/Placebo Coil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain stimulation, rTMS