Anorexia Nervosa
Conditions
Brief summary
OBJECTIVE: Anorexia Nervosa (AN) is a complex disorder of unknown etiology that is characterized by disordered eating behaviors and specific psychopathology. In the course of anorexia around 50% will recover in the first 10 years, 25% will continue to experience symptoms but will be able to function, and 25% will go to develop chronic course, and by definition become severe treatment resistant(Tr). There is little if anything to offer to this population where the range of treatment options is limited to weight restoration interventions. Transcranial magnetic stimulation (rTMS) is a non-invasive intervention, which presents a particular interest in people with severe TrAN, specifically because of its ability to target deeper areas of the brain, such as insula, which has been argued to be a possible trait marker for AN. METHODS: This pilot study will test the efficacy and safety of deep-rTMS delivered with the H-coil in subjects with long standing treatment resistant severe anorexia nervosa (TrAN).
Detailed description
Anorexia Nervosa (AN) is a complex disorder that is characterized by disordered eating behaviors and specific psychopathology. It is frequently unremitting, and is associated with significant morbidity and mortality. There are no effective evidenced based treatments for adult individuals who suffer from this disease, and innovative treatment strategies are constantly being sought. One potential novel treatment approach is brain stimulation, specifically repetitive transcranial magnetic stimulation (rTMS) which has been used to treat various neurobehavioural disorders, including anxiety and depression. There are a number of deep brain regions implicated in the etiology of AN, including the insula. The insula has been identified as an important region in AN pathophysiology. The insula has a role in gustatory modulation and feeding behavior, as well as the processing of interoceptive stimuli and self awareness. In a metanalysis of published fMRI studies in patients with anorexia nervosa, we found hyperactivity in the region of the insula. However activation of such deeper regions with TMS has to date been unachievable as TMS technology has not yet had the capacity to target such deep brain structures. The Brainsway H-coil reaches deep subcortical structures such as the insula. This pilot study will investigate the efficacy and safety of the Brainsway H-coil deep brain rTMS in the treatment of patients with treatment resistant anorexia nervosa (TrAN). The general objective of this study is to investigate the neurological pathways implicated in AN using Hcoil deep rTMS. The specific goal is to test the safety and tolerability of repeated H-coil TMS as a potential treatment for TrAN. Also, if the safety and tolerability of deep H-coil rTMS stimulation is demonstrated in this study, this modality may be useful as a potential treatment strategy for individuals with AN. If both efficacy and safety are demonstrated, then a properly designed randomized controlled trial with deep H-coil rTMS compared to sham rTMS treatment will be implemented to investigate the possible therapeutic effects of H-Coil deep rTMS stimulation.
Interventions
DEVICEDeep Insula-coil rTMS
Before administering TMS participants will undergo cue stimuli provocation, consisting of 32 professional color images of high calorie, sweet and savory food. This will follow with TMS. All subjects will receive prefrontal deep TMS (18 Hz, 2 sec on, 20 sec off, over approximately 30 min) 5 times per week, for 6 weeks, for a total of 30 sessions as a part of an active treatment phase. Maintenance treatment phase will include two sessions of rTMS (18 Hz, 2 sec on, 20 sec off, over approximately half an hour) weekly for the period of 6 weeks.
Sponsors
Brainsway
Centre for Addiction and Mental Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
A pilot study to investigate the efficacy and safety of deep-rTMS delivered with the H-coil able to reach insula in subjects with long standing treatment resistant severe anorexia nervosa (TrAN)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Patients with AN according to DSM-IV criteria: For DSM-IV, amenorrhea will not be strictly applied, as these subjects have been shown to be clinically indistinguishable from those with full criteria AN. * Body Mass Index (BMI) \> 14.0 kg/m2 and \< 18.5 kg/m2 * Ages \> 18 years, \< 55 years * Patient have had \> 2 failed attempts at intensive nutritional rehabilitation, either in an inpatient or day hospital setting, and have been ill with AN for more than 5 years * Medically stable * Competent to provide Informed Consent * Speak and understand English * Safety Screening for rTMS (see
Exclusion criteria
)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seizures | bi-weekly through for 12 weeks | absence of seizures as observed by clinical team and reported by participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in binge eating and purging in B/P group | b-weekly for 12 weeks | as reported by participants |
| Increase in calorie intake | bi-weekly for 12 weeks | as measured by self-report thorough the use of food journal |
| Decrease in depressive and anxiety | bi-weekly for 12 weeks | as measured by HAMD, MADRS, BDI, and BDS |
| Decrease in AN-related obsessions and compulsions | bi-weekly for 12 weeks | as measured by YBOCS-ED |
Countries
Canada
Outcome results
None listed