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A Clinical Trial Into the Efficacy of rTMS Treatment for Treating Anorexia Nervosa and Bulimia Nervosa

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ClinicalTrials.gov Identifier: NCT04061304
Recruitment Status : Not yet recruiting
First Posted : August 19, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
University of Manitoba

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.


Condition or disease Intervention/treatment Phase
Eating Disorders Anorexia Nervosa Bulimia Nervosa Device: Repetitive Transcranial Magnetic Stimulation Device: Sham Transcranial Magnetic Stimulation Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Clinical Trial Into the Efficacy of rTMS Treatment for Treating Anorexia Nervosa and Bulimia Nervosa
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Active rTMS (Anorexia Nervosa)

Patients 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

Device: Repetitive Transcranial Magnetic Stimulation
A non-invasive method of brain stimulation.

Experimental: Active rTMS (Bulimia Nervosa)

Patients 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

Device: Repetitive Transcranial Magnetic Stimulation
A non-invasive method of brain stimulation.

Sham Comparator: Sham rTMS (Anorexia Nervosa)
Patients 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.
Device: Sham Transcranial Magnetic Stimulation
A device designed to look, sound, and feel like a real magnetic stimulation coil without actually stimulating the brain.

Sham Comparator: Sham rTMS (Bulimia Nervosa)
Patients 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.
Device: Sham Transcranial Magnetic Stimulation
A device designed to look, sound, and feel like a real magnetic stimulation coil without actually stimulating the brain.




Primary Outcome Measures :
  1. Weekly Binge/Purge Frequency on Eating Disorder Examination [ Time Frame: baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment. ]
    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.


Secondary Outcome Measures :
  1. Change in Beck Anxiety Inventory (BAI) [ Time Frame: baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment. ]
    Outcome range: 0-63, with higher scores reflecting higher levels of anxiety. A total of 21 questions are summed for a total score out of 63.

  2. Change in Beck Depression Inventory (BDI) [ Time Frame: baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment. ]
    Outcome range: 0-63, with higher scores reflecting higher levels of depression. A total of 21 questions are summed for a total score out of 63.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of Anorexia Nervosa or Bulimia Nervosa, must pass rTMS screening questionnaire

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04061304


Contacts
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Contact: Benjamin Meek 204-237-2677 rtms@sbgh.mb.ca

Sponsors and Collaborators
University of Manitoba
Investigators
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Principal Investigator: Mandana Modirrousta, MD PhD FRCPC University of Manitoba

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Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT04061304     History of Changes
Other Study ID Numbers: HS22828 (B2019:033)
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Manitoba:
rTMS
Additional relevant MeSH terms:
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Anorexia
Bulimia
Feeding and Eating Disorders
Anorexia Nervosa
Bulimia Nervosa
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Hyperphagia