TMS for Anorexia

Overseen By Sasha Gorrell, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: Psychotropic medications

Must not be taking: Seizure risk medications

Disqualifiers: Schizophrenia, Bipolar, Seizure disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 2 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether transcranial magnetic stimulation (TMS), a non-invasive brain therapy, can aid individuals with anorexia nervosa, a condition characterized by restrictive eating and low weight. TMS already treats depression and OCD, which share symptoms with anorexia, such as obsessive thoughts and rigid behaviors. The trial seeks to determine if targeting a specific brain area can improve anorexia symptoms. Individuals diagnosed with anorexia, stable on their medications, and able to handle the study procedures might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore new treatment possibilities for anorexia nervosa.

Will I have to stop taking my current medications?

No, you can continue taking your current medications as long as they have been stable for 4 weeks before the study and you agree to keep taking them throughout the study.

What prior data suggests that this protocol is safe for treating anorexia nervosa?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is generally safe and well-tolerated. Studies have found that it can improve body mass index (BMI) and symptoms in people with anorexia nervosa (AN). Side effects are usually minor and temporary, such as mild headaches or scalp discomfort, which typically resolve on their own.

The FDA has already approved rTMS for treating major depressive disorder and obsessive-compulsive disorder, indicating a good safety record for these conditions. This suggests it might also be safe for anorexia, given some similarities in symptoms.

Overall, current evidence supports the safety of rTMS, making it a promising option for those considering this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Repetitive Transcranial Magnetic Stimulation (rTMS) is unique because it targets brain activity directly through magnetic pulses, unlike traditional anorexia treatments that often focus on psychological therapy or medication. Most treatments for anorexia involve antidepressants or cognitive behavioral therapy aimed at altering thoughts and behaviors. However, rTMS works by modulating neural circuits, specifically targeting the right orbitofrontal cortex (R OFC), which is linked to reward and self-control. Researchers are excited about rTMS because it offers a non-invasive approach that could potentially alter brain function quickly and effectively, providing a new avenue for those who haven't responded to conventional treatments.

What evidence suggests that rTMS might be an effective treatment for anorexia?

Research has shown that repetitive transcranial magnetic stimulation (rTMS), the treatment under study in this trial, might help treat anorexia nervosa (AN). Studies have found improvements in body weight and key symptoms of AN. This treatment is generally safe and well tolerated, with only minor and short-lived side effects. rTMS targets brain areas linked to obsessive thoughts and rigid behaviors, similar to those in OCD. Although more research is needed, early findings suggest rTMS could be promising for people with AN. ^{1 2 3 4 5}

Who Is on the Research Team?

Andrew M Lee, MD, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for outpatients aged 18-45 with Anorexia Nervosa (AN), stable on psychotropic meds for 4 weeks, and able to give informed consent. Excluded are those with schizophrenia, bipolar disorder, severe neurocognitive disorders, seizure disorders, metal in the head or certain implanted devices.

Inclusion Criteria

Meets DSM-5 criteria for AN

Ability to tolerate clinical study procedures

Successfully complete the screening forms without any contraindications

Exclusion Criteria

I am unable to commit to the full duration of the study.

I do not have any unstable health conditions like uncontrolled high blood pressure.

I do not have severe brain-related health issues like major memory problems, seizures, or brain lesions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive five treatments of inhibitory continuous theta burst rTMS to the right orbitofrontal cortex every hour over the course of 10 days

2 weeks

Daily visits for 10 days

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at 1 month and ongoing monthly evaluations for a year

12 months

Monthly visits

What Are the Treatments Tested in This Trial?

Interventions

• Repetitive Transcranial Magnetic Stimulation (rTMS)

Trial Overview The study tests if Repetitive Transcranial Magnetic Stimulation (rTMS) targeting the orbitofrontal cortex can help treat AN by reorganizing brain networks. Participants' responses will be monitored using functional magnetic resonance imaging (fMRI).

How Is the Trial Designed?

Group I: TMS (Aim 2) Experimental Treatment 1 Intervention

Our protocol consists of five treatments of inhibitory continuous TBS (cTBS) to the R OFC lasting three minutes delivered every hour over the course of 10 days (2 weeks) for a total of 50 treatments.

Repetitive Transcranial Magnetic Stimulation (rTMS) is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as rTMS for:

• Depression
• Smoking cessation

Approved in European Union as rTMS for:

• Depression

Approved in Canada as rTMS for:

• Depression

Approved in Japan as rTMS for:

• Depression

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

A pilot study involving 10 right-handed individuals with anorexia nervosa showed that one session of high frequency repetitive transcranial magnetic stimulation (rTMS) was safe and well-tolerated.

After rTMS, participants reported reduced feelings of fullness, fatness, and anxiety, suggesting that rTMS may help alleviate core symptoms of anorexia nervosa and warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation in anorexia nervosa: a pilot study. Van den Eynde, F., Guillaume, S., Broadbent, H., et al.[2022]

In a pilot study involving 10 women with anorexia nervosa, high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) to the right dorsolateral prefrontal cortex (DLPFC) led to changes in food selection, indicating a potential therapeutic effect.

HF-rTMS was associated with increased healthiness ratings for both low- and high-fat foods and a greater selection of high-fat foods, suggesting that this stimulation may help reduce fat avoidance in individuals with anorexia nervosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of high-frequency repetitive transcranial magnetic stimulation to probe the neural circuitry of food choice in anorexia nervosa: A proof-of-concept study. Muratore, AF., Bershad, M., Steinglass, JE., et al.[2022]

In a case series of five women with enduring anorexia nervosa, repetitive transcranial magnetic stimulation (rTMS) to the left dorsolateral prefrontal cortex led to significant improvements in eating disorder symptoms and mood after approximately 20 treatment sessions.

While initial improvements were noted, with some participants showing recovery at the 6-month follow-up, the benefits diminished by the 12-month follow-up, indicating the need for ongoing treatment or additional interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Enduring Anorexia Nervosa: A Case Series. McClelland, J., Kekic, M., Campbell, IC., et al.[2022]

In a study involving two individuals with treatment-resistant anorexia nervosa, 19-20 sessions of high-frequency rTMS applied to the left dorsolateral prefrontal cortex led to improvements in eating disorder symptoms and mood.

The positive effects of rTMS were observed immediately after treatment and continued to improve at a one-month follow-up, indicating its potential as a promising adjunct treatment for anorexia nervosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvements in symptoms following neuronavigated repetitive transcranial magnetic stimulation (rTMS) in severe and enduring anorexia nervosa: findings from two case studies. McClelland, J., Bozhilova, N., Nestler, S., et al.[2018]

In a study involving 29 participants with severe anorexia nervosa, repetitive transcranial magnetic stimulation (rTMS) was found to be an acceptable treatment, although participants noted it was time-consuming.

Post-treatment, many participants reported positive changes in their outlook and willingness to engage with their anorexia nervosa and other life aspects, suggesting rTMS may have beneficial effects beyond just physical health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'My dad was like "it's your brain, what are you doing?"': Participant experiences of repetitive transcranial magnetic stimulation treatment in severe enduring anorexia nervosa. Dalton, B., Austin, A., Ching, BCF., et al.[2022]

This feasibility randomized controlled trial will assess the effects of real versus sham repetitive transcranial magnetic stimulation (rTMS) in 44 adults with severe and enduring anorexia nervosa (SEED-AN), aiming to gather preliminary efficacy data and inform future large-scale studies.

The trial will evaluate a wide range of outcomes, including weight, eating disorder symptoms, quality of life, and neuroimaging measures, to determine the acceptability and tolerability of rTMS as a treatment for SEED-AN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes and neural correlates of 20 sessions of repetitive transcranial magnetic stimulation in severe and enduring anorexia nervosa (the TIARA study): study protocol for a randomised controlled feasibility trial. Bartholdy, S., McClelland, J., Kekic, M., et al.[2022]

In a study involving 26 participants with severe enduring anorexia nervosa (SE-AN), high-frequency repetitive transcranial magnetic stimulation (rTMS) led to a significant reduction in blood flow in the amygdala, which was associated with greater weight gain over 18 months.

The study suggests that changes in regional cerebral blood flow (CBF) could serve as a potential marker for treatment response to rTMS in SE-AN, highlighting the need for further research using neuroimaging to understand the neurobiological effects of this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study exploring the effect of repetitive transcranial magnetic stimulation (rTMS) treatment on cerebral blood flow and its relation to clinical outcomes in severe enduring anorexia nervosa. Dalton, B., Maloney, E., Rennalls, SJ., et al.[2021]

In a study of 63 obese individuals undergoing a 5-week rTMS treatment for weight control, the treatment showed a reassuring safety profile with no unexpected adverse events reported up to one year after treatment.

The most common side effects were moderate headaches (40.4%) and local pain/discomfort (19.2%), particularly more frequent in the high-frequency rTMS group, but overall, rTMS was well tolerated in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of repeated sessions of deep transcranial magnetic stimulation in obesity. Ferrulli, A., Massarini, S., Macrì, C., et al.[2021]

A 24-year-old anorexic patient with depression showed significant improvement in depressive symptoms after two cycles of repetitive transcranial magnetic stimulation (rTMS), highlighting its potential efficacy in treating depression in patients with poor physical health.

Following a third successful rTMS cycle and a maintenance protocol, the patient achieved remission from depression, suggesting that rTMS can be a viable treatment option for comorbid depression in anorexia nervosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transcranial magnetic stimulation for comorbid depression in anorexia]. Kamolz, S., Richter, MM., Schmidtke, A., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11735571/

Efficacy of transcranial magnetic stimulation in anorexia nervosa TMS represents an effective therapy for patients with AN, leading to improvements in both BMI and core symptoms of AN, with minor and transient side effects.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9597650/

Is Repetitive Transcranial Magnetic Stimulation (RTMS) a ... The analyses show that rTMS induced large improvements in body mass index (BMI) among obese individuals. Null clinical effects have been detected for primary ...

3. jeatdisord.biomedcentral.com jeatdisord.biomedcentral.com/articles/10.1186/s40337-021-00420-w

A pilot study exploring the effect of repetitive transcranial ... Repetitive transcranial magnetic stimulation (rTMS) is a novel treatment option for people with severe enduring anorexia nervosa (SE-AN).

4. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.ajp-rj.2023.180302

Repetitive Transcranial Magnetic Stimulation Strategies in ... Findings indicated that rTMS is safe for patients with anorexia nervosa and well tolerated, but large randomized controlled trials comparing ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178117319960

Repetitive transcranial magnetic stimulation in the ... In this review, some studies showed relatively positive results with safe outcomes and with reduction of both craving and eating behaviors with active ...