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Anorexia NervosaNCT05368844

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

A study testing rTMS treatment using BrainsWay Model 104 system with H1-Coil in people with Anorexia Nervosa, run by University of California, San Diego at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Anorexia Nervosa
What is being tested?
rTMS treatment using BrainsWay Model 104 system with H1-Coil
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10 participants
Where
1 siteUnited States
Study dates
16 Jun 2022to 11 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Females ages 18 to 45 years
  • Diagnostic criteria. Current diagnosis of AN according to the DSM V, including having a severe fear of weight gain and body image distortion
  • Restricting or binge/purge subtype
  • English is primary language spoken

Who cannot join

  • Subjects who are pregnant or think they may be pregnant will be excluded from the study.
  • Subjects will not have electrolyte, blood count or kidney or liver function abnormalities. Prior to starting the TMS treatment (Visit 2), all subjects will complete a basic metabolic panel (must be completed within no more than one week prior to the start of the TMS treatment) to rule out electrolyte or metabolic abnormalities.
  • Subjects may not have a lifetime history of a condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT or a febrile seizure of infancy or single seizure related to a known drug related event.
  • Subjects may not have a history of significant head trauma with loss of consciousness 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 or near the head, excluding the mouth, that cannot be safely removed.
  • Subjects may not currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit TMS efficacy or have a history of lack of response to accelerated course of iTBS or rTMS in the past.
Show all 16Show fewer
  • Subjects may not have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump.
  • Subjects may not have symptoms of alcohol or substance abuse or dependence in the past month, may not have previous or current organic brain syndromes, psychotic disorders, bipolar type disorders, somatization disorders, or conversion disorder.
  • Antidepressant bupropion or other seizure threshold lowering medication or are currently taking tricyclic antidepressants or neuroleptics.
  • Permanent eye makeup (such as eyeliner or eyebrows) or other face tattoos due to potential ferrous materials used in the tattoo ink
  • Subjects may not have a history of neurocardiogenic syncope as there is an increased risk of TMS-induced neurocardiogenic syncope in adolescent populations.
  • Subjects may not have implanted neurostimulators, intracardiac lines, or heart disease that causes moderate to severe symptoms and/or is characterized by moderate to severe pathology (including a recent history of myocardial infarction and heart failure with an ejection fraction of less than 30% or with a New York Heart Association 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 be asked to refrain from consuming alcohol for the duration of the study. At the beginning of each treatment day subjects will be asked about alcohol consumption in the last 48 hours and will not complete the treatment sessions that day if they have had alcohol in the last 48 hours.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California San Diego

    San Diego, California, 92121

Other trials in United States

About this study

Official title: Harnessing Neurostimulation to Improve Treatment Outcome in Anorexia Nervosa

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.

Read the 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).

Being tested
rTMS treatment using BrainsWay Model 104 system with H1-Coil, sham TMS using BrainsWay Model 104 system with H1-Coil
Medical subject headings
Anorexia Nervosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rTMS treatment using BrainsWay Model 104 system with H1-CoilDevice

    5 days of 10 daily sessions of rTMS treatment

  • sham TMS using BrainsWay Model 104 system with H1-CoilDevice

    5 days of 10 daily sessions of sham iTBS treatment

Study groups in NCT05368844
Study groupRoleWhat they receive
Active iTBSExperimentalrTMS treatments will employ the Brainsway stimulator (Brainsway Ltd, Israel). Prior to the first treatment (no more than 5 days prior), each subject's motor threshold (MT) will first be determined according to published methods (Schutter, van Honk, 2006; Julkunen et al, 2009). This location, as well as the stimulation target spot, will be marked at the first session on the scalp and standard methods will be used to target this spot during treatment sessions. The modified BeamF3 scalp heuristic will be used to localize the treatment site over the left DLPFC (Mir-Moghtadaei et al., 2015). Subjects will complete 5 treatments days. A treatment day will consist of 10 treatment sessions with the start of each session timed to be at least 50 minutes from the previous session.
Receives: Device: rTMS treatment using BrainsWay Model 104 system with H1-Coil
Sham iTBSSham comparatorThe BrainsWay Model 104 with H4 coil has an integrated sham coil. The sham condition will start with the same clicking noise as the active TMS condition. Every helmet has a corresponding sham H-coil encased in the same helmet. The sham coil induces only a negligible sub-threshold field in the brain while making an identical noise and inducing some scalp sensation. Subjects will complete 5 treatments days. A treatment day will consist of 10 treatment sessions with the start of each session timed to be at least 50 minutes from the previous session. Subjects in this arm will have the option of receiving the Active iTBS protocol after they complete the 5 days of 10 daily treatment sessions.
Receives: Device: sham TMS using BrainsWay Model 104 system with H1-Coil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of TMS sessions

    To establish feasibility of iTBS in anorexia nervosa the investigator will assess the following: total percent of sessions completed by the subject.

    Measured: at study completion, up to 2 weeks

  2. Acceptability of TMS procedures

    To establish acceptability of iTBS in anorexia nervosa the investigator will assess the following: subjects will be asked open-ended questions about the subject's experience of the study.

    Measured: at study completion, up to 2 weeks

Secondary outcomes (6)
  1. Eating Disorders Inventory 3 Drive for Thinness Subscale

    The Eating Disorders Inventory 3 is a self report assessment that measures core eating disorder symptoms. Subjects will complete this measure at the beginning and end of the study and the investigator will measure the change in scores. The Drive for Thinness Subscale has a range of 0 to 28 where higher scores mean worse outcome.

    Measured: Change from baseline to study completion, up to 2 weeks

  2. Eating Disorders Inventory 3 (EDI-3) Body Dissatisfaction Subscale

    The Eating Disorders Inventory 3 is a self report assessment that measures core eating disorder symptoms. Subjects will complete this measure at the beginning and end of the study and the investigator will measure the change in scores. The Drive for Thinness Subscale has a range of 0 to 40 where higher scores mean worse outcome.

    Measured: Change from baseline to study completion, up to 2 weeks

  3. Weight gain

    Body Mass Index over time as a measure of food intake from the start to end of the study.

    Measured: Change in body mass index from baseline to study completion, up to 2 weeks

  4. Spielberger State-Trait Anxiety Scale-Version Y (STAI-Y) State Anxiety Subscale

    The Spielberger State-Trait Anxiety Scale-Version Y is a self report assessment that measure state and trait anxiety. Subjects will complete this measure at the beginning and end of the study and the investigator will measure the change in scores of State Anxiety. State anxiety has a range of 0 to 80 with higher scores indicating worse outcome.

    Measured: Change from baseline to study completion, up to 2 weeks

  5. Spielberger State-Trait Anxiety Scale-Version Y (STAI-Y) Trait Anxiety Subscale

    The Spielberger State-Trait Anxiety Scale-Version Y is a self report assessment that measure state and trait anxiety. Subjects will complete this measure at the beginning and end of the study and the investigator will measure the change in scores of Trait Anxiety. Trait anxiety has a range of 0 to 80 with higher scores indicating worse outcome.

    Measured: Change from baseline to study completion, up to 2 weeks

  6. Beck Depression Inventory

    The Beck Depression Inventory is a self report assessment that measures depression. Subjects will complete this measure at the beginning and end of the study and the investigator will measure the change in scores. The score range is from 0 to 63 with higher scores indicating worse outcome.

    Measured: Change from baseline to study completion, up to 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2022
  2. Study start16 Jun 2022
  3. Primary completion11 Mar 2026
  4. Study completion11 Mar 2026

Why it stopped: Study funding ended prior to completing the study enrollment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study aims to test the feasibility, safety and acceptability of a new form of TMS, intermittent theta-burst stimulation (iTBS), in anorexia nervosa and to test whether iTBS can reduce body image distortion and facilitate eating in anorexia nervosa.
Masking
Single blind
Who is masked
Participant
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05368844
Sponsor's protocol ID
202030
Status last verified
Jul 2026
First submitted
20 Apr 2022
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Cole EJ, Stimpson KH, Bentzley BS, Gulser M, Cherian K, Tischler C, Nejad R, Pankow H, Choi E, Aaron H, Espil FM, Pannu J, Xiao X, Duvio D, Solvason HB, Hawkins J, Guerra A, Jo B, Raj KS, Phillips AL, Barmak F, Bishop JH, Coetzee JP, DeBattista C, Keller J, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Am J Psychiatry. 2020 Aug 1;177(8):716-726. doi: 10.1176/appi.ajp.2019.19070720. Epub 2020 Apr 7.

    PubMed 32252538
  • Schutter DJ, van Honk J. A standardized motor threshold estimation procedure for transcranial magnetic stimulation research. J ECT. 2006 Sep;22(3):176-8. doi: 10.1097/01.yct.0000235924.60364.27.

    PubMed 16957532
  • Mir-Moghtadaei A, Caballero R, Fried P, Fox MD, Lee K, Giacobbe P, Daskalakis ZJ, Blumberger DM, Downar J. Concordance Between BeamF3 and MRI-neuronavigated Target Sites for Repetitive Transcranial Magnetic Stimulation of the Left Dorsolateral Prefrontal Cortex. Brain Stimul. 2015 Sep-Oct;8(5):965-73. doi: 10.1016/j.brs.2015.05.008. Epub 2015 May 29.

    PubMed 26115776
  • Frank GKW, DeGuzman MC, Shott ME. Motivation to eat and not to eat - The psycho-biological conflict in anorexia nervosa. Physiol Behav. 2019 Jul 1;206:185-190. doi: 10.1016/j.physbeh.2019.04.007. Epub 2019 Apr 10.

    PubMed 30980856

Questions about this trial

What is this clinical trial studying?

A study testing rTMS treatment using BrainsWay Model 104 system with H1-Coil in people with Anorexia Nervosa, run by University of California, San Diego at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Study funding ended prior to completing the study enrollment.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of TMS sessions (time frame: at study completion, up to 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05368844, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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