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High-frequency vs. Low-frequency vs. Sham DMPFC-rTMS for Bulimia and Anorexia Nervosa

Primary Purpose

Bulimia Nervosa, Anorexia Nervosa

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High-frequency rTMS
Low-frequency rTMS
Sham rTMS
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bulimia Nervosa focused on measuring brain stimulation, rTMS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Toronto Western Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

High-frequency rTMS

Low-frequency rTMS

Sham rTMS

Arm Description

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

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

Sham repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks

Outcomes

Primary Outcome Measures

Weekly Binge/Purge Frequency on Eating Disorder Examination (EDE)
Outcome measured by a change in weekly binge and purge episodes from baseline to 2 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A final score of 0 weekly binges and 0 weekly vomits is categorized as remission.

Secondary Outcome Measures

Eating Disorder Inventory-3
Eating Disorder Examination Questionnaire (EDE-Q)

Full Information

First Posted
March 2, 2016
Last Updated
September 27, 2021
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02702167
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 pandemic restrictions.
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa, Anorexia Nervosa
Keywords
brain stimulation, rTMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-frequency rTMS
Arm Type
Experimental
Arm Description
10 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks
Arm Title
Low-frequency rTMS
Arm Type
Experimental
Arm Description
1 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
Sham repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks
Intervention Type
Device
Intervention Name(s)
High-frequency rTMS
Other Intervention Name(s)
Magventure Cool DB80 Active/Placebo Coil
Intervention Description
10 Hz active stimulation, once daily
Intervention Type
Device
Intervention Name(s)
Low-frequency rTMS
Other Intervention Name(s)
Magventure Cool DB80 Active/Placebo Coil
Intervention Description
1 Hz active stimulation, once daily
Intervention Type
Device
Intervention Name(s)
Sham rTMS
Other Intervention Name(s)
Magventure Cool DB80 Active/Placebo Coil
Intervention Description
Sham stimulation, once daily
Primary Outcome Measure Information:
Title
Weekly Binge/Purge Frequency on Eating Disorder Examination (EDE)
Description
Outcome measured by a change in weekly binge and purge episodes from baseline to 2 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A final score of 0 weekly binges and 0 weekly vomits is categorized as remission.
Time Frame
Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment
Secondary Outcome Measure Information:
Title
Eating Disorder Inventory-3
Time Frame
Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment
Title
Eating Disorder Examination Questionnaire (EDE-Q)
Time Frame
Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment
Other Pre-specified Outcome Measures:
Title
Resting-state functional MRI
Description
10 min resting-state functional MRI acquisition at 3T
Time Frame
1 week pre- and 1 week post-intervention

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 (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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Downar, MD PhD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Blake Woodside, MD FRCPC
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T2S8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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High-frequency vs. Low-frequency vs. Sham DMPFC-rTMS for Bulimia and Anorexia Nervosa

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