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Transcranial Magnetic Stimulation

TMS for Anorexia

N/A

Recruiting

Led By Guido Frank, MD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

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

Must have

Females ages 18 to 45 years

Current diagnosis of Anorexia Nervosa (AN) according to the DSM V, including having a severe fear of weight gain and body image distortion

Must not have

Current intake of antidepressant bupropion, seizure threshold lowering medication, tricyclic antidepressants, or neuroleptics

Current intake of more than lorazepam 2 mg daily or any dose of an anticonvulsant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at study completion, up to 2 weeks

Summary

This trial is testing whether TMS, a new brain stimulation technique, can help treat anorexia nervosa, a severe psychiatric disorder associated with food avoidance and body image distortion.

Who is the study for?

This trial is for English-speaking females aged 18 to 45 with Anorexia Nervosa as per DSM V, either restricting or binge/purge subtype. Participants must not be pregnant, have metal implants near the head, major medical illnesses, substance abuse issues in the last month, certain psychiatric disorders, abnormal blood tests results or a history of seizures among other exclusions.

What is being tested?

The study is testing Transcranial Magnetic Stimulation (TMS) using BrainsWay Model 104 system with H1-Coil to see if it can change brain activity and improve symptoms of Anorexia Nervosa. Some participants will receive real TMS while others get sham TMS without active treatment for comparison.

What are the potential side effects?

Potential side effects from TMS may include discomfort at the stimulation site on the scalp, headache, lightheadedness, tingling sensations or muscle twitches during treatment sessions. There's also a small risk of seizure but this is rare.

Eligibility Criteria

Inclusion Criteria

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

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I am a woman aged between 18 and 45.

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I have been diagnosed with Anorexia Nervosa and have a severe fear of gaining weight.

Exclusion Criteria

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

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I am currently taking antidepressants or medication for seizures.

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I take more than 2 mg of lorazepam daily or I am on anticonvulsants.

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I have a neurostimulator, intracardiac lines, or significant heart disease.

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I have a family history of epilepsy.

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I have had a stroke or other brain issues in the past.

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I have had a severe head injury with unconsciousness for over 5 minutes.

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I do not have a major illness, cardiac pacemaker, or medication pump.

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I have a history of conditions that could increase pressure inside my skull.

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I have a history of fainting due to heart-brain issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at study completion, up to 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at study completion, up to 2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at study completion, up to 2 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Acceptability of TMS procedures

Feasibility of TMS sessions

Secondary study objectives

Beck Depression Inventory

Eating Disorders

Eating Disorders Inventory 3 Drive for Thinness Subscale

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active iTBSExperimental Treatment1 Intervention

rTMS 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.

Group II: Sham iTBSPlacebo Group1 Intervention

The 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.

0 / 11Eligibility criteria met