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

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ClinicalTrials.gov Identifier: NCT02702167
Recruitment Status : Recruiting
First Posted : March 8, 2016
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
Blake Woodside, University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Bulimia Nervosa Anorexia Nervosa Device: High-frequency rTMS Device: Low-frequency rTMS Device: Sham rTMS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2022

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 Name: 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 Name: 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 Name: Magventure Cool DB80 Active/Placebo Coil




Primary Outcome Measures :
  1. 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.


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

Other Outcome Measures:
  1. Resting-state functional MRI [ Time Frame: 1 week pre- and 1 week post-intervention ]
    10 min resting-state functional MRI acquisition at 3T



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02702167


Contacts
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Contact: Eileen Lam 416-603-5800 ext 5494 eileen.lam@uhn.ca
Contact: Katie Dunlop 416-603-5667 katie.dunlop@uhn.ca

Locations
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Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T2S8
Contact: Eileen Lam    416-603-5667    eileen.lam@uhn.ca   
Contact: Katie Dunlop    416-603-5667    katie.dunlop@uhn.ca   
Principal Investigator: Jonathan Downar, MD, PhD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Jonathan Downar, MD PhD University Health Network, Toronto
Principal Investigator: Blake Woodside, MD FRCPC University Health Network, Toronto

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Responsible Party: Blake Woodside, Psychiatrist, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02702167     History of Changes
Other Study ID Numbers: 16-6252-B
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Blake Woodside, University Health Network, Toronto:
brain stimulation
rTMS
Additional relevant MeSH terms:
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Anorexia
Bulimia
Anorexia Nervosa
Bulimia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders
Hyperphagia