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Clinical Trials/NCT04409704
NCT04409704CompletedPhase 1

Repetitive Transcranial Magnetic Stimulation of the Dorsomedial Prefrontal Cortex as a Treatment for Anorexia Nervosa and Bulimia Nervosa: An Open-Label Case Series

University Health Network, Toronto0 sites60 target enrollmentStarted: December 11, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
60
Primary Endpoint
Eating Disorder Examination (EDE)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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:
  • •Past or current neurological illness
  • •Comorbid schizophrenia
  • •Current suicidal intent or plan
  • •Contraindications to MRI or rTMS (e.g., metallic implants/foreign bodies)

Arms & Interventions

10 Hz

Experimental

10 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 4-6 weeks

Intervention: Repetitive Transcranial Magnetic Stimulation (Device)

Outcomes

Primary Outcomes

Eating Disorder Examination (EDE)

Time Frame: Change from baseline to 1 week post-treatment completion.

Weekly Binge/Purge Frequency on Eating Disorder Examination (EDE), a semi-structured interview assessing the full range of the specific psychopathology of eating disorders.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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