NCT05368844

Transcranial Magnetic Stimulation (TMS) in the Treatment of Anorexia Nervosa

Harnessing Neurostimulation to Improve Treatment Outcome in Anorexia Nervosa

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Anorexia nervosa is a severe psychiatric disorder associated with food avoidance and body image distortion, that is feeling fat despite being underweight. It is the third most common chronic illness among adolescent females, and its mortality reaches its peak between the ages 16 and 29 years old. There are very few treatments for anorexia nervosa and especially no biological treatments have been approved. Recent brain imaging research has repeatedly implicated brain circuits that include the insula in the disorder. The insula is a brain region important in taste processing as well as in the integration of body perception and has strong connections to the brain reward system. Transcranial magnetic stimulation (TMS) is a relatively new methodology that has been shown to alter neurocircuitry and alleviate depression. Here, the study goal is to develop TMS as a methodology to change altered neurocircuitry in anorexia nervosa and alleviate disorder specific behaviors.

Detailed description

The goals for this study are 1) to test the feasibility of iTBS in AN and 2) to gather pilot data to as proof of concept of its effectiveness in AN prior to applying for larger funding to the NIH. Subjects will complete a battery of self-assessments and a diagnostic assessment in order to determine eligibility and for characterization of behavior to be used in later analyses. After eligibility is confirmed, subjects will take part in iTBS treatment over either 1 week (active iTBS groups) or 2 weeks, (1 week sham treatment group, followed by 1 week active iTBS). The design will be a randomized control design that also includes a cross over design. Subjects will be randomized to either Group 1, Active iTBS, or Group 2, Sham/Active iTBS. Group 1 will receive active iTBS over 5 days, with 10 brief sessions per day (5 study days/50 session total). Group 2 will receive Sham over 5 days, with 10 brief sessions per day, and this will be followed by active iTBS over 5 days, with 10 brief sessions per day (20 study days/100 session total).

Conditions

• Anorexia Nervosa

Interventions

Type	Name	Description
DEVICE	rTMS treatment using BrainsWay Model 104 system with H1-Coil	5 days of 10 daily sessions of rTMS treatment
DEVICE	sham TMS using BrainsWay Model 104 system with H1-Coil	5 days of 10 daily sessions of sham iTBS treatment

Timeline

• Start date: 2022-06-16
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2022-05-10
• Last updated: 2025-09-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study