The effects of repetitive transcranial magnetic stimulation in obese females with binge eating disorder: a protocol for a double-blinded, randomized, sham-controlled trial.
BACKGROUND
Binge eating disorder is a new category in DSM-5 and highly associated with higher body mass index. The neural mechanisms that underlie binge eating are of great interest in order to improve treatment interventions. Brain mechanisms underlying drug and food craving are suggested to be similar: for example, both are reported to be associated with increased neural activity in the orbitofrontal and anterior cingulate cortex, and a diminished regulatory influence from lateral prefrontal circuits. Several studies have begun to assess the potential benefits of brain stimulation in reducing craving and addictive behaviors. Data from a study of a one-off session of transcranial magnetic stimulation in healthy women identified as strong cravers and of individuals with bulimic-type eating disorders, reported a reduction in food craving and binge eating episodes. This provides support for a more extensive investigation of the potential therapeutic benefits of transcranial magnetic stimulation. Lastly, brain imaging studies and a dimensional approach, will improve understanding of the neural correlates of the disorders and of the mode of action of transcranial magnetic stimulation.


METHODS
Sixty eligible obese females, with binge eating disorder, will be randomly allocated to receive 20 sessions of transcranial magnetic stimulation intervention (n = 30) or the sham transcranial magnetic stimulation intervention (n = 30) scattered 3 days/week. Thirty eligible controls will complete the baseline assessment. The primary outcome (number of binge eating episodes) will be assed at each treatment sessions, and 8 weeks after intervention completion (follow-up). It is hypothesized that mean weekly binge-eating episodes will be reduced in the intervention group, compared to the sham group, and that the effect will be maintained at follow-up.


CONCLUSIONS
Despite the severity associated with Binge Eating Disorder, there are limited treatment options. This study is an important step in the development of more effective treatments. Importantly, the study is the first to investigating binge eating disorder using a dimensional approach, by looking at the different aspects of the disorder, such as behavioral factors, biological factors, brain circuits and chemistry.


BACKGROUND
Clinical Trials NCT02180984 . Registered in July 2014.
Eating Disorder Unit, Psychiatry Department, Universidade Federal de São Paulo (UNIFESP), R. Borges Lagoa, 570, 7th floor, CEP 04038-020, São Paulo, SP, Brazil. mara.proata@gmail.com.
Mara Fernandes
MF
Maranhão
Eating Disorder Unit, Psychiatry Department, Universidade Federal de São Paulo (UNIFESP), R. Borges Lagoa, 570, 7th floor, CEP 04038-020, São Paulo, SP, Brazil. naramendes@post.harvard.edu.
Nara Mendes
NM
Estella
Eating Disorder Unit, Psychiatry Department, Universidade Federal de São Paulo (UNIFESP), R. Borges Lagoa, 570, 7th floor, CEP 04038-020, São Paulo, SP, Brazil. m.elisa@clinicapsico.com.br.
Maria Elisa Gisbert
ME
Cury
Eating Disorder Unit, Psychiatry Department, Universidade Federal de São Paulo (UNIFESP), R. Borges Lagoa, 570, 7th floor, CEP 04038-020, São Paulo, SP, Brazil. veruskalastoria@uol.com.br.
Veruska Lastoria
VL
Amigo
Eating Disorder Unit, Psychiatry Department, Universidade Federal de São Paulo (UNIFESP), R. Borges Lagoa, 570, 7th floor, CEP 04038-020, São Paulo, SP, Brazil. clarissalli@gmail.com.
Clarissa Mollinero
CM
Picasso
Laboratory Integrative Neuroscience (LiNC), Psychiatric Department, Universidade Federal de São Paulo (UNIFESP), R. Pedro de Toledo, 669, 3rd floor, CEP 04039-032, São Paulo, SP, Brazil. Arthur.berberian@gmail.com.
Arthur
A
Berberian
Section of Eating Disorder, Institute of Psychiatry, King's College London, Denmark Hill, SE5 8AF, London, UK. Iain.campbell@kcl.ac.uk.
Iain
I
Campbell
Section of Eating Disorder, Institute of Psychiatry, King's College London, Denmark Hill, SE5 8AF, London, UK. ulrike.schmidt@kcl.ac.uk.
Ulrike
U
Schmidt
Eating Disorder Unit, Psychiatry Department, Universidade Federal de São Paulo (UNIFESP), R. Borges Lagoa, 570, 7th floor, CEP 04038-020, São Paulo, SP, Brazil. aclaudino@unifesp.br.
Angélica Medeiros
AM
Claudino
D000328:Adult; D056912:Binge-Eating Disorder / Q000097:blood / Q000150:complications* / Q000628:therapy*; D002985:Clinical Protocols; D066249:Craving; D004311:Double-Blind Method; D004967:Estrogens / Q000097:blood; D005260:Female; D059907:Functional Neuroimaging; D054439:Ghrelin / Q000097:blood; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D018836:Inflammation Mediators / Q000097:blood; D020738:Leptin / Q000097:blood; D008875:Middle Aged; D009483:Neuropsychological Tests; D009765:Obesity / Q000097:blood / Q000150:complications* / Q000628:therapy; D050781:Transcranial Magnetic Stimulation; D016896:Treatment Outcome
D004967:Estrogens; D054439:Ghrelin; D018836:Inflammation Mediators; D020738:Leptin; D006854:Hydrocortisone