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Anorexia in AdolescenceFEDNCT05249140

Finding Treatments for Eating Disorders

A study testing Repetitive Transcranial Magnetic Stimulation in people with Anorexia in Adolescence, run by University of Calgary at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Anorexia in Adolescence
What is being tested?
Repetitive Transcranial Magnetic Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteCanada
Study dates
31 Dec 2022to 31 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Diagnosis of Anorexia Nervosa (AN) by medical and psychiatric assessment at the Calgary Eating Disorder Program.
  • English fluency (i.e., able to consent and assent to the study)
  • Aged 12 to 18
  • Medically stable
  • Medications for AN or psychiatric disorders are allowed if the dose has been stable for six weeks with adequate compliance, with a commitment to not change medication/dosage during the trial period. If a medication change occurs, the research team will document this.

Who cannot join

  • Diagnosis of mania or psychosis
  • Impediments to TMS or MRI (i.e., braces, having non-MRI compatible metals in the body)
  • Diagnosis of Autism Spectrum Disorder
  • Diagnosis of post-concussive syndrome
  • Plans to move/be unavailable for clinic visits for 6 to 9 months after the start of treatment

Trial locations and contacts

1 site in 1 country.

Frank P MacMaster, PhD contact

4039552784

fmacmast@ucalgary.ca

Kayla D Stone, PhD contact

4039555447

kayla.stone1@ucalgary.ca

Canada1 site
  • Alberta Children's Hospital

    Calgary, Alberta, T2N 1N4

    Frank MacMaster, PhD, 4039552784, fmacmast@ucalgary.ca

Other trials in Canada

About this study

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.

Read more

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.

Read the detailed description

norexia nervosa (AN) is a serious psychiatric illness with the highest mortality rate of any other psychiatric disorder. Medical complications from starvation and malnutrition and suicide are the most common cause of death. AN is characterized by a person's fear of gaining weight, becoming fat, and body dissatisfaction, and it has a lifetime prevalence of 0.6 to 2.0% in females. Currently, Family Based Treatment (FBT) is the leading evidence-based, manualized treatment for adolescents with AN. FBT emphasizes parental involvement in addressing disordered eating by supporting the child in eating and refeeding in order to achieve a healthy body weight and independent eating. FBT has been shown to promote rapid weight gain in AN patients in several randomized control trials and reduced hospitalization in AN patients . 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 . There continues to be limited empirical research and clinical knowledge about what differentiates those who consistently gain weight and those who do not in the critical window for weight gain in the first month of FBT. FBT works in part by reducing the avoidance of food and increasing the exposure to food triggers, similar to 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.

While FBT is the first-line treatment for adolescents with AN, response is unfortunately not universal. An understanding of the neurobiology of AN could potentially improve treatment development and response. Unfortunately, the neurobiology of AN is poorly understood, and in turn, neuroscientifically-sound treatments are lacking. In order 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. rTMS involves a safe, non-invasive, painless application of a magnetic field over the skull to a target brain area in order to change its activity and function. 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. Furthermore, some studies have shown that rTMS is effective in reducing core symptoms of anorexia in adults, however, this has yet to be explored in adolescents. 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.

Being tested
Repetitive Transcranial Magnetic Stimulation
Keywords
Transcranial Magnetic Stimulation, Magnetic Resonance Imaging, Adolescence, Anorexia
Medical subject headings
Anorexia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Repetitive Transcranial Magnetic StimulationDevice

    rTMS involves a safe, non-invasive, painless application of a magnetic field over the skull to a target brain area in order to change its activity and function.

Study groups in NCT05249140
Study groupRoleWhat they receive
Active Repetitive Transcranial Magnetic StimulationExperimentalrTMS 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).
Receives: Device: Repetitive Transcranial Magnetic Stimulation
Sham Repetitive Transcranial Magnetic StimulationSham comparatorFor 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
Receives: Device: Repetitive Transcranial Magnetic Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Change in anxiety as measured by the Multidimensional Anxiety Scale for Children (MASC-2) from baseline to 6 weeks in early non-responders to FBT receiving active rTMS as compared to those receiving sham-rTMS.

    Measured: Six weeks

  2. Primary Outcome - Number of subjects achieving weight restoration

    Number of early non-responders to FBT who achieve weight restoration (i.e., >95% of expected mean BMI) at the end of active rTMS of the DLPFC treatment as compared to those receiving sham-rTMS.

    Measured: Six weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2022
  2. Study start31 Dec 2022 (estimated)
  3. Primary completion31 Jan 2025 (estimated)
  4. Study completion31 May 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05249140
Sponsor's protocol ID
REB21-0472
Acronym
FED
Status last verified
Jun 2021
First submitted
21 Jun 2021
Last updated
10 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We can share anonymous or aggregated data only upon request.

Questions about this trial

What is this clinical trial studying?

A study testing Repetitive Transcranial Magnetic Stimulation in people with Anorexia in Adolescence, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Frank P MacMaster, PhD (4039552784, fmacmast@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome - Change in anxiety as measured by the Multidimensional Anxiety Scale for Children (MASC-2) from baseline to 6 weeks. (time frame: Six weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022; AzTrials last refreshed its copy on 30 Oct 2026.

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