Bulimia Nervosa, Anorexia Nervosa
Conditions
Keywords
brain stimulation, rTMS
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.
Interventions
DEVICEHigh-frequency rTMS
10 Hz active stimulation, once daily
DEVICELow-frequency rTMS
1 Hz active stimulation, once daily
DEVICESham rTMS
Sham stimulation, once daily
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Resting-state functional MRI | 1 week pre- and 1 week post-intervention | 10 min resting-state functional MRI acquisition at 3T |
Countries
Canada
Outcome results
None listed