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OpenTrials
Completed

NCT Number: NCT04409704

Repetitive Transcranial Magnetic Stimulation of the DMPFC for Anorexia and Bulimia: an Open-Label Case Series

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • Pregnancy.

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

10 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week, 20-30 sessions.

Other names: High-frequency rTMS, Magventure DB80 Coil

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Klarman Family Foundation

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jun 1, 2020
Registry last updated
Jun 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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