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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up six weeks

Awards & highlights

FED Trial 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.Check my eligibility

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.See study design

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.

FED Trial 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.

FED Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

- 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

FED 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

791 Previous Clinical Trials

868,710 Total Patients Enrolled

University of AlbertaOTHER

886 Previous Clinical Trials

384,754 Total Patients Enrolled

Frank P MacMaster, PhDPrincipal InvestigatorUniversity of Calgary

2 Previous Clinical Trials

89 Total Patients Enrolled

Media Library

Repetitive Transcranial Magnetic Stimulation Clinical Trial Eligibility Overview. Trial Name: NCT05249140 — N/A

Anorexia Nervosa Research Study Groups: Active Repetitive Transcranial Magnetic Stimulation, Sham Repetitive Transcranial Magnetic Stimulation

Anorexia Nervosa Clinical Trial 2023: Repetitive Transcranial Magnetic Stimulation Highlights & Side Effects. Trial Name: NCT05249140 — N/A

Repetitive Transcranial Magnetic Stimulation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05249140 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the minimum age requirement for this trial 18 and above?

"This clinical trial delineates that suitable applicants must be aged between 12 and 18. Specifically, 70 trials are dedicated to minors while 73 are for seniors above the age of 65."

Answered by AI

How can I become involved in this research endeavor?

"Eligibility for this research requires patients to be of pre-adult age (12 - 18) and currently diagnosed with anorexia. Approximately 24 participants need to be enrolled."

Answered by AI

Is this experimental study accepting new participants?

"At present, clinicaltrials.gov reports that this trial is not enrolling patients. The study was initially uploaded on December 31st 2022 and has been modified as recently as February 22nd 2022. In spite of this, there are 156 other trials currently seeking participants across the country."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Finding Treatments for Eating Disorders

2022. "Finding Treatments for Eating Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05249140.

All > Anorexia Nervosa > Eating Disorder