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rTMS for Anorexia Nervosa (FED Trial)

N/A

Waitlist Available

Led By Frank P MacMaster, PhD

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

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

Must have

Aged 12 to 18

Diagnosis of Anorexia Nervosa (AN) by medical and psychiatric assessment at the Calgary Eating Disorder Program

Must not have

Diagnosis of post-concussive syndrome

Plans to move/be unavailable for clinic visits for 6 to 9 months after the start of treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up six weeks

Summary

This trial will investigate whether rTMS to the right DLPFC can help reduce anxiety and increase the likelihood of weight gain in adolescents with AN who are not responding to FBT.

Who is the study for?

This trial is for adolescents aged 12 to 18 with Anorexia Nervosa, as confirmed by medical and psychiatric assessment. Participants must be medically stable, fluent in English, and on a steady dose of any AN or psychiatric medications for six weeks prior without plans to change during the study.

What is being tested?

The trial tests if Repetitive Transcranial Magnetic Stimulation (rTMS) can improve outcomes in Family Based Treatment (FBT) for anorexia by targeting brain areas related to anxiety. It focuses on whether stimulating the right DLPFC enhances FBT effectiveness.

What are the potential side effects?

Potential side effects of rTMS may include discomfort at the stimulation site, headache, lightheadedness, or seizures; however these are generally rare. The specific side effects will depend on individual responses to treatment.

Eligibility Criteria

Inclusion Criteria

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

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I am between 12 and 18 years old.

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I have been diagnosed with Anorexia Nervosa by the Calgary Eating Disorder Program.

Exclusion Criteria

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

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I have been diagnosed with post-concussive syndrome.

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I plan to be available for clinic visits for at least 6-9 months after starting treatment.

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I have been diagnosed with mania or psychosis.

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I have been diagnosed with Autism Spectrum Disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ six weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~six weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and six 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

- Change in anxiety as measured by the Multidimensional Anxiety Scale for Children (MASC-2) from baseline to 6 weeks.

- Number of subjects achieving weight restoration

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active Repetitive Transcranial Magnetic StimulationExperimental Treatment1 Intervention

rTMS parameters are intensity 110% resting motor threshold (RMT), frequency 1Hz, duration = 30 minutes (1800 stimulations), targeting the right DLPFC. To target the dorsolateral prefrontal cortex (DLPFC) for rTMS treatment we will use the traditional method (i.e. the 5cm rule; George et al., 1995, 1996; Herwig et al., 2001, 2003; MacMaster et al., 2019), in which the TMS coil is placed 5 cm anterior to the participant's motor cortex along a line to the nasion. Treatments will occur on weekdays at the same time of day for 4 weeks (20 total).

Group II: Sham Repetitive Transcranial Magnetic StimulationPlacebo Group1 Intervention

For the sham rTMS group, a sham coil is used: this sham method does not emit any magnetic field, and therefor does not affect brain activity, but it does produce auditory sensations that is indistinguishable from active rTMS in naïve subjects

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Repetitive Transcranial Magnetic Stimulation

2013

Completed Phase 3

~1170

0 / 6Eligibility criteria met