Repetitive Transcranial Magnetic Stimulation of the DMPFC for Anorexia and Bulimia: an Open-Label Case Series
Primary Purpose
Bulimia Nervosa, Anorexia Nervosa
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Bulimia Nervosa focused on measuring Eating Disorders, rTMS, Anorexia, Bulimia
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:
- Past or current neurological illness
- Comorbid schizophrenia
- Current suicidal intent or plan
- Contraindications to MRI or rTMS (e.g., metallic implants/foreign bodies)
- Pregnancy.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
10 Hz
Arm Description
10 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 4-6 weeks
Outcomes
Primary Outcome Measures
Eating Disorder Examination (EDE)
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 Outcome Measures
Full Information
NCT ID
NCT04409704
First Posted
May 21, 2020
Last Updated
May 26, 2020
Sponsor
University Health Network, Toronto
Collaborators
Klarman Family Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04409704
Brief Title
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
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
December 11, 2011 (Actual)
Primary Completion Date
April 30, 2015 (Actual)
Study Completion Date
December 7, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Klarman Family Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa, Anorexia Nervosa
Keywords
Eating Disorders, rTMS, Anorexia, Bulimia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
10 Hz
Arm Type
Experimental
Arm Description
10 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 4-6 weeks
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Other Intervention Name(s)
High-frequency rTMS, Magventure DB80 Coil
Intervention Description
10 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week, 20-30 sessions.
Primary Outcome Measure Information:
Title
Eating Disorder Examination (EDE)
Description
Weekly Binge/Purge Frequency on Eating Disorder Examination (EDE), a semi-structured interview assessing the full range of the specific psychopathology of eating disorders.
Time Frame
Change from baseline to 1 week post-treatment completion.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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:
Past or current neurological illness
Comorbid schizophrenia
Current suicidal intent or plan
Contraindications to MRI or rTMS (e.g., metallic implants/foreign bodies)
Pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Downar, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Blake Woodside, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33865456
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.
Results Reference
derived
Learn more about this trial
Repetitive Transcranial Magnetic Stimulation of the DMPFC for Anorexia and Bulimia: an Open-Label Case Series
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