What side effects are associated with this type of intervention?

Transcranial Magnetic Stimulation (TMS) is being studied as a treatment for Anorexia Nervosa (AN) due to its potential to modulate neural activity in the orbitofrontal cortex. Common side effects of TMS include mild headaches, scalp discomfort at the stimulation site, tingling, spasms, or twitching of facial muscles, and, in rare cases, seizures. Other treatments for AN, such as cognitive-behavioral therapy (CBT) and pharmacotherapy, can have side effects like increased anxiety, gastrointestinal issues, and sleep disturbances. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved Transcranial Magnetic Stimulation (TMS) for the treatment of refractory Major Depressive Disorder (MDD) and obsessive-compulsive disorder (OCD). While TMS is not yet FDA-approved specifically for Anorexia Nervosa (AN), there is emerging research exploring its potential benefits for AN due to the overlap in obsessive thought patterns and compulsive behaviors seen in both OCD and AN. This research focuses on modulating neural activity in the orbitofrontal cortex, a known target for TMS in OCD, to potentially alleviate symptoms of AN.

What other types of research exist?

Promising novel alternatives to TMS for treating anorexia nervosa include transcranial direct current stimulation (tDCS) and deep brain stimulation (DBS). tDCS has shown potential in improving cognitive flexibility and reducing compulsive behaviors, which are relevant to anorexia nervosa. DBS, although more invasive, has been effective in treating obsessive-compulsive disorder and may offer benefits for anorexia nervosa due to the overlap in neural substrates and symptomatology.

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Neuromodulation

TMS for Anorexia

N/A

Recruiting

Led By Andrew M Lee, MD, PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Capacity to provide informed consent

Be between 18 and 65 years old

Must not have

Subjects with an unstable physical, systemic, or metabolic disorder (e.g., unstable hypertension)

Neurologic: severe neurocognitive disorder, seizure disorder, certain structural brain lesions (e.g., intracranial mass lesions, hydrocephalus, sequelae of meningitis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline; all 10 days of tms; every follow-up (weeks 1, 2, & 3 after final tms treatment; every month for a year).

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

Possible side effects of rTMS include discomfort at the stimulation site, headache, lightheadedness, seizures (very rare), and temporary hearing changes due to the noise during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I understand the details of the clinical trial and can consent to participate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I don't have metal implants in my head, certain tics, or conditions increasing seizure risk.

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I am not pregnant or nursing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; day 1, 5, & 10 of tms; every follow-up (weeks 1, 2, & 3 after final tms treatment; every month for a year).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; day 1, 5, & 10 of tms; every follow-up (weeks 1, 2, & 3 after final tms treatment; every month for a year).

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; day 1, 5, & 10 of tms; every follow-up (weeks 1, 2, & 3 after final tms treatment; every month for a year). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Eating Disorders Examination - Questionnaire (EDE-Q)

Secondary study objectives

Compulsive Exercise Test (CET)

Ecological Momentary Assessment (EMA)

Hamilton Self-Rating Scale for Depression (HAM-D)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TMS (Aim 2)Experimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Repetitive Transcranial Magnetic Stimulation (rTMS)

2019

Completed Phase 2

~780

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Transcranial Magnetic Stimulation (TMS) is a non-invasive treatment that modulates neural activity by using magnetic fields to stimulate nerve cells in specific brain regions, such as the orbitofrontal cortex (OFC). The OFC is involved in decision-making and reward processing, which are often disrupted in Anorexia Nervosa (AN). By targeting this area, TMS aims to alleviate obsessive thoughts and compulsive behaviors related to food and body image, potentially improving cognitive flexibility and reducing maladaptive habits. Understanding these mechanisms is crucial for AN patients as it offers a targeted approach to address the underlying neural dysfunctions, providing a potential alternative when traditional therapies are insufficient.

Repetitive transcranial magnetic stimulation in the treatment of eating disorders: A review of safety and efficacy.