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

Anorexia Nervosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04061304
• Other study ID #: HS22828 (B2019:033)
• Status: Withdrawn
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: March 19, 2021

Study information

• Verified date: March 2021
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 19, 2021
• Est. primary completion date: March 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Bulimia
• Bulimia Nervosa
• Eating Disorders
• Feeding and Eating Disorders

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation
A non-invasive method of brain stimulation.
• Sham Transcranial Magnetic Stimulation
A device designed to look, sound, and feel like a real magnetic stimulation coil without actually stimulating the brain.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment.
Secondary	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.	baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment.