TMS for Anorexia

Overseen By Sasha Gorrell, PhD

Age: 18 - 65

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

Trial Summary

What is the purpose of this trial?

This trial uses a type of brain stimulation called theta burst rTMS to treat adults with Anorexia Nervosa. The treatment targets a specific brain area involved in obsessive and compulsive behaviors. The goal is to reduce these symptoms and improve patients' eating habits. Theta burst stimulation (TBS) is a newer and more effective form of repetitive transcranial magnetic stimulation (rTMS) that has shown promise in treating neuropsychiatric disorders.

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 data supports the effectiveness of the treatment Repetitive Transcranial Magnetic Stimulation (rTMS) for Anorexia?

Research shows that repetitive transcranial magnetic stimulation (rTMS) may help improve symptoms in people with severe anorexia, as seen in case studies where patients experienced changes in food choices and improvements in related conditions like depression. ^{1 2 3 4 5}

Is repetitive transcranial magnetic stimulation (rTMS) safe for humans?

Repetitive transcranial magnetic stimulation (rTMS) has been shown to be safe and well-tolerated in clinical trials, including those involving people with obesity and anorexia nervosa. ^{1 2 6 7 8}

How is repetitive transcranial magnetic stimulation (rTMS) different from other treatments for anorexia nervosa?

Repetitive transcranial magnetic stimulation (rTMS) is unique because it is a brain-directed treatment that uses magnetic fields to stimulate specific areas of the brain, such as the dorsolateral prefrontal cortex, which may help reduce symptoms of anorexia nervosa. Unlike traditional therapies, rTMS is non-invasive and does not involve medication, making it a novel option for those with treatment-resistant anorexia or comorbid conditions like depression. ^{1 3 4 7 9}

Research Team

Andrew M Lee, MD, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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 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 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]

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]

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 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 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 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 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]

References

1. England 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. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Enduring Anorexia Nervosa: A Case Series. [2022]

3. United States 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. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

[Transcranial magnetic stimulation for comorbid depression in anorexia]. [2021]

5. England 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Safety and tolerability of repeated sessions of deep transcranial magnetic stimulation in obesity. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation in anorexia nervosa: a pilot study. [2022]

8. England 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. [2021]

9. England 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. [2022]