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

Last updated: March 25, 2025
Sponsor: University of California, San Diego
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Anorexia

Vomiting

Treatment

rTMS treatment using BrainsWay Model 104 system with H1-Coil

sham TMS using BrainsWay Model 104 system with H1-Coil

Clinical Study ID

NCT05368844
202030
  • Ages 18-45
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Females ages 18 to 45 years

  • Diagnostic criteria. Current diagnosis of AN according to the DSM V, includinghaving a severe fear of weight gain and body image distortion

  • Restricting or binge/purge subtype

  • English is primary language spoken

Exclusion

Exclusion Criteria:

  • Subjects who are pregnant or think they may be pregnant will be excluded from thestudy.

  • Subjects will not have electrolyte, blood count or kidney or liver functionabnormalities. Prior to starting the TMS treatment (Visit 2), all subjects willcomplete a basic metabolic panel (must be completed within no more than one weekprior to the start of the TMS treatment) to rule out electrolyte or metabolicabnormalities.

  • Subjects may not have a lifetime history of a condition likely to be associated withincreased intracranial pressure, space occupying brain lesion, any history ofseizure except those therapeutically induced by ECT or a febrile seizure of infancyor single seizure related to a known drug related event.

  • Subjects may not have a history of significant head trauma with loss ofconsciousness for greater than 5 minutes.

  • Subjects may not have an intracranial implant (e.g., aneurysm clips, shunts,stimulators, cochlear implants, or electrodes) or any other metal object within ornear the head, excluding the mouth, that cannot be safely removed.

  • Subjects may not currently take more than lorazepam 2 mg daily (or equivalent) orany dose of an anticonvulsant due to the potential to limit TMS efficacy or have ahistory of lack of response to accelerated course of iTBS or rTMS in the past.

  • Subjects may not have a concomitant major unstable medical illness, cardiacpacemaker or implanted medication pump.

  • Subjects may not have symptoms of alcohol or substance abuse or dependence in thepast month, may not have previous or current organic brain syndromes, psychoticdisorders, bipolar type disorders, somatization disorders, or conversion disorder.

  • Antidepressant bupropion or other seizure threshold lowering medication or arecurrently taking tricyclic antidepressants or neuroleptics.

  • Permanent eye makeup (such as eyeliner or eyebrows) or other face tattoos due topotential ferrous materials used in the tattoo ink

  • Subjects may not have a history of neurocardiogenic syncope as there is an increasedrisk of TMS-induced neurocardiogenic syncope in adolescent populations.

  • Subjects may not have implanted neurostimulators, intracardiac lines, or heartdisease that causes moderate to severe symptoms and/or is characterized by moderateto severe pathology (including a recent history of myocardial infarction and heartfailure with an ejection fraction of less than 30% or with a New York HeartAssociation Functional Classification of Class III or IV).

  • Subjects may not have a history of stroke or other brain lesions.

  • Subjects may not have a history of suicide attempt(s).

  • Subject may not have a family history of epilepsy.

  • Cannot refrain from drinking alcohol for the duration of the study. Subjects will beasked to refrain from consuming alcohol for the duration of the study. At thebeginning of each treatment day subjects will be asked about alcohol consumption inthe last 48 hours and will not complete the treatment sessions that day if they havehad alcohol in the last 48 hours.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: rTMS treatment using BrainsWay Model 104 system with H1-Coil
Phase:
Study Start date:
June 16, 2022
Estimated Completion Date:
October 01, 2025

Study 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).

Connect with a study center

  • University of California San Diego

    San Diego, California 92121
    United States

    Site Not Available

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