TMS for Anorexia
Recruiting in Palo Alto (17 mi)
Overseen byAndrew M Lee, MD, PhD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
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
Approved in 4 Jurisdictions
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.
12345Is 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.
12678How 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.
13479Eligibility 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
+5 more
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.
+3 more
Trial 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
Participant Groups
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).
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, San FranciscoSan Francisco, CA
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Who Is Running the Clinical Trial?
University of California, San FranciscoLead Sponsor
References
Improvements in symptoms following neuronavigated repetitive transcranial magnetic stimulation (rTMS) in severe and enduring anorexia nervosa: findings from two case studies. [2018]Advances in the treatment of anorexia nervosa (AN) are most likely to arise from targeted, brain-directed treatments, such as repetitive transcranial magnetic stimulation (rTMS). We describe findings from two individuals with treatment-resistant AN who received 19-20 sessions of neuronavigated, high frequency rTMS, applied to the left dorsolateral prefrontal cortex.
Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Enduring Anorexia Nervosa: A Case Series. [2022]This case series examined the therapeutic potential of repetitive transcranial magnetic stimulation in five women with enduring anorexia nervosa.
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]Repetitive transcranial magnetic stimulation (rTMS) is used to modulate neural systems and provides the opportunity for experimental tests of hypotheses regarding mechanisms underlying anorexia nervosa (AN). The present pilot study has investigated whether high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) to a region of the right dorsolateral prefrontal cortex (DLPFC) might be associated with change in food selection among adult inpatients with AN. Ten women received one session of sham and one session of HF-rTMS targeting the right DLPFC while completing a computerized Food Choice Task. Compared to sham, HF-rTMS was associated with changes in food ratings and food choice: inpatients reported higher healthiness ratings of low- and high-fat foods and selected a significantly greater proportion of high-fat foods over a neutrally rated reference item while receiving HF-rTMS. Findings suggest that HF-rTMS to the right DLPFC was associated with a reduction of fat avoidance on a food choice task among inpatients with AN and provide additional support for the possibility that this region, and related neural circuits, may underlie restrictive food choice. Research using rTMS to experimentally test neural mechanisms is needed to elucidate the underpinnings of AN and supports the development of novel treatment targets.
[Transcranial magnetic stimulation for comorbid depression in anorexia]. [2021]A 24-year-old anorexic patient with cormobid symptoms of depression was treated for depression with repetitive transcranial magnetic stimulation (rTMS) rather than with psychopharmacotherapy, due to her poor physical condition. The depressive symptomatology significantly improved in correlation with two rTMS cycles but occurred again within 2 weeks. A third successful cycle was then followed by a maintenance rTMS protocol with the patient going into remission from depression. This case illustrates that rTMS may be considered as a therapeutic option for comorbid depression in anorectic patients.
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]Anorexia nervosa (AN) is a serious mental disorder with multiple comorbidities and complications. In those with a severe and enduring form of the illness (SEED-AN), treatment responsivity is poor and the evidence base limited. Thus, there is a need for novel treatment strategies. This paper describes the theoretical background and protocol of a feasibility randomised controlled trial (RCT) of real versus sham (placebo) therapeutic repetitive transcranial magnetic stimulation (rTMS) in SEED-AN. The aim of this trial is to obtain information that will guide decision making and protocol development in relation to a future large-scale RCT of rTMS in this group of patients, and also to assess the preliminary efficacy and neural correlates of rTMS treatment.
Safety and tolerability of repeated sessions of deep transcranial magnetic stimulation in obesity. [2021]Repetitive Transcranial Magnetic Stimulation (rTMS) has been demonstrated to be effective in body weight control in individuals with obesity. Most clinical trials on rTMS provided a reassuring safety profile. In the present work, we present an extensive analysis on both severe and mild Adverse Events (AEs) in obese individuals treated with rTMS.
Repetitive transcranial magnetic stimulation in anorexia nervosa: a pilot study. [2022]The search for new treatments to improve outcome in people with anorexia nervosa continues. This pilot study investigated whether one session of high frequency repetitive transcranial magnetic stimulation (rTMS) delivered to the left dorsolateral prefrontal cortex reduces eating disorder related symptoms following exposure to visual and real food stimuli. Safety and tolerability were also assessed. Ten right-handed people with anorexia nervosa underwent one session of rTMS. Subjective experiences related to the eating disorder (e.g. urge to restrict, feeling full etc.) were assessed before and after rTMS. Non-parametric repeated measures tests were used. rTMS was safe and well-tolerated, and resulted in reduced levels of feeling full, feeling fat and feeling anxious. Thus, rTMS may reduce core symptoms of anorexia nervosa. Future research should establish the therapeutic potential of rTMS in anorexia nervosa.
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]Repetitive transcranial magnetic stimulation (rTMS) is a novel treatment option for people with severe enduring anorexia nervosa (SE-AN), but associated neurobiological changes are poorly understood. This study investigated the effect of rTMS treatment on regional cerebral blood flow (CBF) and whether any observed changes in CBF are associated with changes in clinical outcomes in people with SE-AN.
'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]Repetitive transcranial magnetic stimulation (rTMS) is a promising emerging treatment for anorexia nervosa (AN). However, to date, patients' views and experiences of this treatment have not been fully explored. To assess these, we integrated a qualitative study into a feasibility randomised controlled trial of rTMS in individuals with severe enduring AN.