Clinical trial NCT02702167: High-frequency vs. Low-frequency vs. Sham DMPFC-rTMS for Bulimia and Anorexia Nervosa
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bulimia Nervosa
Anorexia Nervosa
Keywords: brain stimulation
rTMS
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Weekly Binge/Purge Frequency on Eating Disorder Examination (EDE)
timeFrame: Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment
Secondary outcomes:
measure: Eating Disorder Inventory-3
timeFrame: Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment
measure: Eating Disorder Examination Questionnaire (EDE-Q)
timeFrame: Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment
Other outcomes:
measure: Resting-state functional MRI
timeFrame: 1 week pre- and 1 week post-intervention
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Jonathan Downar, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Blake Woodside, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: