Study Stopped
Challenges with funding acquisition prevented study commencement.
A Clinical Trial Into the Efficacy of rTMS Treatment for Treating Anorexia Nervosa and Bulimia Nervosa
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
This is a pilot study to test the efficacy of repetitive transcranial magnetic stimulation (rTMS) in treating individuals with Anorexia Nervosa and Bulimia Nervosa. The main objective of this study is to determine the short and long-term efficacy of repetitive transcranial magnetic stimulation (rTMS) in reducing eating disorder symptoms (i.e. binging, purging, restricting, intense fear of gaining wait, etc;) in Anorexia Nervosa and Bulimia Nervosa. The investigators will also be comparing the brain activity patterns of individuals with Anorexia Nervosa and Bulimia Nervosa to healthy controls using electroencephalography (EEG). Further, the investigators would like to examine if the activation patterns in these patients change after receiving rTMS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2020
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2019
CompletedFirst Posted
Study publicly available on registry
August 19, 2019
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2021
CompletedOctober 8, 2021
March 1, 2021
10 months
July 2, 2019
October 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weekly Binge/Purge Frequency on Eating Disorder Examination
Outcome measured by change of binge/purge episodes from baseline to the end of treatment. If the participant has a final score of 0 binges and 0 purges they will be considered in remission. A 50% improvement will be defined as a response to the rTMS.
baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment.
Secondary Outcomes (2)
Change in Beck Anxiety Inventory (BAI)
baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment.
Change in Beck Depression Inventory (BDI)
baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment.
Study Arms (4)
Active rTMS (Anorexia Nervosa)
EXPERIMENTALPatients in this arm will receive 40 sessions of active rTMS. Every day, the first session of rTMS for both groups will be applied to the left DLPFC using intermittent Theta Burst Stimulation (iTBS). For the second session each day the patients in the anorexia group will receive low-frequency treatment (1 Hz, 60 second cycles, 30 second inter-train interval, 20 trains, 1200 total pulses) at 120% of the resting motor threshold to the orbitofrontal cortex
Active rTMS (Bulimia Nervosa)
EXPERIMENTALPatients in this arm will receive 40 sessions of active rTMS. Every day, the first session of rTMS for both groups will be applied to the left DLPFC using intermittent Theta Burst Stimulation (iTBS). For the second session each day the patients in the bulimia group will receive high-frequency (10 Hz, 5 second cycles, 50 pulses, 25 second inter-train interval, 60 trains, 3000 total) at 120% of the resting motor threshold treatment to the left dorsomedial prefrontal cortex
Sham rTMS (Anorexia Nervosa)
SHAM COMPARATORPatients in this arm will receive 40 sessions of sham rTMS. They will be set up the same as the active Anorexia Nervosa group however their will be no actual brain stimulation.
Sham rTMS (Bulimia Nervosa)
SHAM COMPARATORPatients in this arm will receive 40 sessions of sham rTMS. They will be set up the same as the active Bulimia Nervosa group however their will be no actual brain stimulation.
Interventions
A non-invasive method of brain stimulation.
A device designed to look, sound, and feel like a real magnetic stimulation coil without actually stimulating the brain.
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of Anorexia Nervosa or Bulimia Nervosa, must pass rTMS screening questionnaire
You may not qualify if:
- Diagnosis of another psychiatric disorder, except MDD.
- Any rTMS counter-indications:
- History of seizures
- Metal in head
- Currently pregnant
- Having received rTMS for any reason in the past as this would interfere with participant blinding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mandana Modirrousta, MD PhD FRCPC
University of Manitoba
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2019
First Posted
August 19, 2019
Study Start
June 1, 2020
Primary Completion
March 19, 2021
Study Completion
March 19, 2021
Last Updated
October 8, 2021
Record last verified: 2021-03