24 Participants Needed

rTMS for Anorexia Nervosa

(FED Trial)

FP
KD
Overseen ByKayla D Stone, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Calgary
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Currently, Family Based Treatment (FBT) is the leading evidence-based, manualized treatment for adolescents with anorexia nervosa (AN). FBT emphasizes parental involvement in addressing disordered eating by supporting the child in eating and refeeding to achieve a healthy body weight and independent eating. Based on multiple RCTs, 50% of AN patients who receive FBT recover, and those who do not are more likely to develop a chronic illness. Research demonstrates that weight gain of less than 2.3kg (4.8 pounds) by week 4 of FBT predicts that 75% of adolescents with AN will not achieve weight restoration by the end of treatment. FBT works in part by reducing the avoidance of food and increasing the exposure to food triggers, like the treatment of anxiety disorders and obsessive-compulsive disorder (OCD). Thus, researchers postulate that anxiety may be a negative predictor of FBT treatment outcome in the early phase of FBT. In addition, elevated baseline anxiety has been shown to be associated with poorer outcomes at end of treatment and may also impact the likelihood of early response. To improve clinical response, we need to develop viable biological treatment targets (i.e., brain areas implicated in anxiety) that could be combined with FBT. Such targets can be defined by 1) initially targeting brain areas that mediate symptoms hindering treatment response (i.e., anxiety), and 2) looking at changes in brain chemistry and function. Thus, repetitive transcranial magnetic stimulation (rTMS) could be an alternative and promising treatment approach for adolescents with AN who do not respond to Phase 1 of FBT. Using rTMS, we can target the brain areas implicated in anxiety in people with anorexia and modulate that activity to reduce symptoms, and thus, facilitate response to FBT. Several studies have shown the rTMS to the right dorsolateral prefrontal cortex (DLPFC) is effective in reducing anxiety across a range of neuropsychiatric disorders. Therefore, it is possible that stimulating the right DLPFC could facilitate treatment efficacy of FBT in youth with AN. Additional explorations of the connections between, and neurochemistry of, the right DLPFC and those mediating emotion in the brain (e.g., amygdala) could aid in our understanding of the networks impeding effective treatment responses and allow for more tailored, precision targeting with TMS.

Will I have to stop taking my current medications?

You can continue taking your current medications as long as the dose has been stable for six weeks before the trial and you agree not to change the medication or dosage during the trial period.

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

Research shows that rTMS, a treatment that uses magnetic fields to stimulate the brain, may help reduce symptoms of anorexia nervosa, such as feeling full or anxious, and is safe and well-tolerated. Studies involving people with severe anorexia nervosa have shown improvements in symptoms after receiving rTMS sessions.12345

Is rTMS safe for people with anorexia nervosa?

Research indicates that rTMS is generally safe and well-tolerated in people with anorexia nervosa, as shown in a pilot study where participants experienced no significant adverse effects.23567

How does rTMS treatment differ from other treatments for anorexia nervosa?

rTMS (repetitive transcranial magnetic stimulation) is unique because it is a brain-directed treatment that uses magnetic fields to stimulate specific areas of the brain, like the dorsolateral prefrontal cortex, which may help reduce symptoms of anorexia nervosa. Unlike traditional therapies that focus on psychological or nutritional interventions, rTMS directly targets neural circuits involved in food choice and eating behaviors.34568

Research Team

FP

Frank P MacMaster, PhD

Principal Investigator

University of Calgary

Eligibility Criteria

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.

Inclusion Criteria

English fluency (i.e., able to consent and assent to the study)
I am between 12 and 18 years old.
My health condition is currently stable.
See 2 more

Exclusion Criteria

I have been diagnosed with post-concussive syndrome.
I plan to be available for clinic visits for at least 6-9 months after starting treatment.
I have been diagnosed with mania or psychosis.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Family Based Treatment (FBT) Phase 1

Participants undergo Family Based Treatment (FBT) focusing on parental involvement to address disordered eating and achieve healthy body weight

4 weeks
Weekly visits

Repetitive Transcranial Magnetic Stimulation (rTMS)

Participants receive rTMS targeting the right dorsolateral prefrontal cortex to reduce anxiety and facilitate response to FBT

4 weeks
20 visits (weekdays)

Follow-up

Participants are monitored for changes in anxiety and weight restoration after treatment

6 weeks

Treatment Details

Interventions

  • Repetitive Transcranial Magnetic Stimulation
Trial OverviewThe 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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials
827
Recruited
902,000+

University of Alberta

Collaborator

Trials
957
Recruited
437,000+

Findings from Research

In a follow-up study of 24 participants with severe anorexia nervosa, those who originally received real rTMS showed a medium effect size in BMI improvement after 18 months, with five achieving weight recovery compared to only one in the sham group.
Both groups experienced further improvements in eating disorder symptoms over time, indicating that while rTMS has lasting effects on mood, significant changes in BMI and symptoms may take longer to develop.
Repetitive transcranial magnetic stimulation treatment in severe, enduring anorexia nervosa: An open longer-term follow-up.Dalton, B., Lewis, YD., Bartholdy, S., 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.
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]
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.
Repetitive transcranial magnetic stimulation in anorexia nervosa: a pilot study.Van den Eynde, F., Guillaume, S., Broadbent, H., et al.[2022]

References

Repetitive transcranial magnetic stimulation treatment in severe, enduring anorexia nervosa: An open longer-term follow-up. [2021]
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]
Repetitive transcranial magnetic stimulation in anorexia nervosa: a pilot study. [2022]
Altered cortical excitability in anorexia nervosa. [2014]
Improvements in symptoms following neuronavigated repetitive transcranial magnetic stimulation (rTMS) in severe and enduring anorexia nervosa: findings from two case studies. [2018]
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) Treatment in Enduring Anorexia Nervosa: A Case Series. [2022]
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]