Finding Treatments for Eating Disorders
FED
1 other identifier
interventional
24
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2021
CompletedFirst Posted
Study publicly available on registry
February 21, 2022
CompletedStudy Start
First participant enrolled
December 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2025
CompletedMarch 10, 2022
June 1, 2021
2.1 years
June 21, 2021
February 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Six weeks
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.
Six weeks
Study Arms (2)
Active Repetitive Transcranial Magnetic Stimulation
EXPERIMENTALrTMS 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).
Sham Repetitive Transcranial Magnetic Stimulation
SHAM 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Calgarylead
- University of Albertacollaborator
Study Sites (1)
Alberta Children's Hospital
Calgary, Alberta, T2N 1N4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank P MacMaster, PhD
University of Calgary
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2021
First Posted
February 21, 2022
Study Start
December 31, 2022
Primary Completion
January 31, 2025
Study Completion
May 31, 2025
Last Updated
March 10, 2022
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share
We can share anonymous or aggregated data only upon request.