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

Anorexia Nervosa Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02702167
• Other study ID #: 16-6252-B
• Status: Terminated
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: April 30, 2021

Study information

• Verified date: September 2021
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Bulimia
• Bulimia Nervosa

Intervention

Device:
• High-frequency rTMS
10 Hz active stimulation, once daily
• Low-frequency rTMS
1 Hz active stimulation, once daily
• Sham rTMS
Sham stimulation, once daily

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Resting-state functional MRI	10 min resting-state functional MRI acquisition at 3T	1 week pre- and 1 week post-intervention
Primary	Weekly Binge/Purge Frequency on Eating Disorder Examination (EDE)	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.	Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment
Secondary	Eating Disorder Inventory-3		Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment
Secondary	Eating Disorder Examination Questionnaire (EDE-Q)		Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment