Clinical trial NCT04409704: Repetitive Transcranial Magnetic Stimulation of the DMPFC for Anorexia and Bulimia: an Open-Label Case Series
Official title: Repetitive Transcranial Magnetic Stimulation of the Dorsomedial Prefrontal Cortex as a Treatment for Anorexia Nervosa and Bulimia Nervosa: An Open-Label Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bulimia Nervosa
Anorexia Nervosa
Keywords: Eating Disorders
rTMS
Anorexia
Bulimia
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Klarman Family Foundation
First posted: 2020-06-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This project proposes to perform a pilot study of fMRI targeted Dorsomedial Prefrontal Cortex repetitive transcranial magnetic stimulation (DMPFC-rTMS) on individuals diagnosed with Bulimia Nervosa (BN) and Anorexia Nervosa (AN). The DMFPC is a novel target for rTMS, is heavily implicated in the regulation of mood and affect, and has been suggested to be involved in AN, BN, major depression, OCD, and PTSD. Improved function in this area might lead to reduced AN and BN symptoms, such as bingeing, purging, and over-activity, perhaps by improved regulation of mood and affect. Improvements in important areas of comorbidity might allow for better response to intensive treatment for AN and BN, and reduce relapse rates after such treatment. The DMPFC may be a more appropriate target for compared to the Dorsolateral Prefrontal Cortex (DLPFC), which has typically been the focus of stimulation in the past. Our initial preliminary pilot work has noted unexpected and significant improvements in some core ED symptoms (bingeing and purging) and in important areas of comorbidity (OCD and PTSD), along with expected improvements in mood. These changes have allowed some treatment resistant patients to either complete intensive treatment or be successful in maintaining their progress post intensive treatment. Subjects will receive up to 30 sessions of bilateral DMPFC-rTMS. Response will be evaluated clinically, via psychometric measures, and pre and post fMRI.


Eligibility criteria: Inclusion Criteria:

Patients will be included if they:

* Are voluntary and competent to consent to treatment.
* Have met DSM-5 diagnostic criteria for Anorexia Nervosa or Bulimia Nervosa, over the last 6 months at minimum

Exclusion Criteria:

Patients will be excluded if they have:

1. Past or current neurological illness
2. Comorbid schizophrenia
3. Current suicidal intent or plan
4. Contraindications to MRI or rTMS (e.g., metallic implants/foreign bodies)
5. Pregnancy.

Primary outcomes:
measure: Eating Disorder Examination (EDE)
timeFrame: Change from baseline to 1 week post-treatment completion.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Health Network, Toronto
name: Jonathan Downar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Blake Woodside, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woodside DB, Dunlop K, Sathi C, Lam E, McDonald B, Downar J. A pilot trial of repetitive transcranial magnetic stimulation of the dorsomedial prefrontal cortex in anorexia nervosa: resting fMRI correlates of response. J Eat Disord. 2021 Apr 17;9(1):52. doi: 10.1186/s40337-021-00411-x.