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

September 27, 2021 updated by: Blake Woodside, University Health Network, Toronto

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T2S8
        • Toronto Western Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-frequency rTMS
10 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks
Device: High-frequency rTMS
10 Hz active stimulation, once daily
Other Names:
  • Magventure Cool DB80 Active/Placebo Coil
Experimental: Low-frequency rTMS
1 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks
Device: Low-frequency rTMS
1 Hz active stimulation, once daily
Other Names:
  • Magventure Cool DB80 Active/Placebo Coil
Sham Comparator: Sham rTMS
Sham repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks
Device: Sham rTMS
Sham stimulation, once daily
Other Names:
  • Magventure Cool DB80 Active/Placebo Coil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weekly Binge/Purge Frequency on Eating Disorder Examination (EDE)
Time Frame: Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment
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.
Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Eating Disorder Inventory-3
Time Frame: Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment
Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment
Eating Disorder Examination Questionnaire (EDE-Q)
Time Frame: Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment
Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting-state functional MRI
Time Frame: 1 week pre- and 1 week post-intervention
10 min resting-state functional MRI acquisition at 3T
1 week pre- and 1 week post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Jonathan Downar, MD PhD, University Health Network, Toronto
  • Principal Investigator: Blake Woodside, MD FRCPC, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

March 2, 2016

First Submitted That Met QC Criteria

March 2, 2016

First Posted (Estimate)

March 8, 2016

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-6252-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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