NCT02702167

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
1.7 years until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

3.5 years

First QC Date

March 2, 2016

Last Update Submit

September 27, 2021

Conditions

Bulimia NervosaAnorexia Nervosa

Keywords

brain stimulationrTMS

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment

Secondary Outcomes (2)

  • Eating Disorder Inventory-3

    Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment

  • Eating Disorder Examination Questionnaire (EDE-Q)

    Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment

Other Outcomes (1)

  • Resting-state functional MRI

    1 week pre- and 1 week post-intervention

Study Arms (3)

High-frequency rTMS

EXPERIMENTAL

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

Device: High-frequency rTMS

Low-frequency rTMS

EXPERIMENTAL

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

Device: Low-frequency rTMS

Sham rTMS

SHAM COMPARATOR

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

Device: Sham rTMS

Interventions

High-frequency rTMSDEVICE

10 Hz active stimulation, once daily

Also known as: Magventure Cool DB80 Active/Placebo Coil
High-frequency rTMS
Low-frequency rTMSDEVICE

1 Hz active stimulation, once daily

Also known as: Magventure Cool DB80 Active/Placebo Coil
Low-frequency rTMS
Sham rTMSDEVICE

Sham stimulation, once daily

Also known as: Magventure Cool DB80 Active/Placebo Coil
Sham rTMS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

Location

MeSH Terms

Conditions

Bulimia NervosaAnorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Jonathan Downar, MD PhD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

  • Blake Woodside, MD FRCPC

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychiatrist

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 8, 2016

Study Start

November 1, 2017

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

September 29, 2021

Record last verified: 2021-09

Locations

CA(1)