Insula-coil Deep TMS for Treatment Resistant Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional

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.
    

Intervention name(s): Deep Insula-coil rTMS
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): deep H-coil rTMS; deep insula rTMS
Intervention model: Single Group Assignment
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)
Masking: None (Open Label)
Primary purpose: Device Feasibility