Ignite Creation Date:
2024-05-06 @ 10:03 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03144986
Status:
COMPLETED
Last Update Posted:
2017-08-29
First Post:
2017-04-24
Brief Title:
Insula-coil Deep TMS for Treatment Resistant Anorexia Nervosa
Sponsor:
Centre for Addiction and Mental Health
Organization:
Centre for Addiction and Mental Health
Study Overview
Official Title:
A Pilot Study to Determine the Safety and Efficacy of H-Coil Deep Transmagnetic Stimulation in Treatment Resistant Anorexia Nervosa
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 resistantTr 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None