An interventional study of Repetitive Transcranial Magnetic Stimulation and Sham Transcranial Magnetic Stimulation in Eating Disorders, Anorexia Nervosa and Bulimia Nervosa, sponsored by University of Manitoba. Withdrawn. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-08.
Sponsored by University of Manitoba · Not applicable, Interventional, and Treatment
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.
411 studies on the registry are indexed under Anorexia; 67 are open to participants now.
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Exclusion Criteria:
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
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
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
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 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.
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.
Time frame: baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment.
Change in Beck Anxiety Inventory (BAI)
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.
Time frame: 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)
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.
Time frame: baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment.
No study locations are listed for this record.
This study is withdrawn, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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University of Manitoba