The Effects of Repetitive Transcranial Magnetic Stimulation in Obese People With BED
Condition: Binge Eating; Obesity
MeSH terms: Bulimia; Binge-Eating Disorder
Study type: Interventional

Summary: 
      The presence of binge eating (BE) is a core feature of bulimic syndromes. Binge eating
      disorder (BED) is a new category in DSM-5 highly associated with higher body mass index
      (BMI). The neural mechanisms that underlie BE are of great interest in order to improve
      treatment interventions. Brain mechanisms underlying drug and food craving are suggested to
      be similar. These mechanisms demonstrated hyperactivity in the orbitofrontal and anterior
      cingulate cortex and lack of regulatory influence from lateral prefrontal circuits. Several
      novel studies began to assess the potential benefits of brain stimulation in reducing craving
      and associated addictive behaviors with promising results. Previous findings testing a
      one-off session of repetitive transcranial magnetic stimulation (rTMS) in healthy women
      identified as strong cravers and individuals with bulimia nervosa or bulimic-type eating
      disorders reported reduction of food craving and BE, providing evidence to support a broader
      and deeper investigation of the benefits associated with rTMS. Importantly, the use of brain
      imaging studies contributes to the understanding of psychiatric disorders and underlying
      mechanisms being target by the rTMS intervention.

      Objectives: The primary aim is to investigate the effects of rTMS over BE frequency.
      Secondary aims include the evaluation of the effects of rTMS on food craving, body weight,
      brain activity, cognition, general psychopathology, hormonal regulation and neurobiological
      markers. Methods: Sixty obese females with BED will be randomized to receive 20 sessions of
      rTMS (n=30) or placebo (n=30) scattered 3 days/week.

      Expected Results: Primarily it is expected that rTMS intervention will decrease BE frequency.
      Consequently, body weight will be reduced. It is also expected that food craving be
      decreased, cognitive performance be enhanced, and neurobiological markers be improved.
    

Detailed description: 
      The primary aim is to investigate the effects of rTMS over BE frequency. Secondary aims
      include the evaluation of the effects of rTMS on food craving, body weight, brain activity,
      cognition, general psychopathology, hormonal regulation and neurobiological markers. Methods:
      Sixty obese females with BED will be randomized to receive 20 sessions of rTMS (n=30) or
      placebo (n=30) scattered 3 days/week.

      Expected Results: Primarily it is expected that rTMS intervention will decrease BE frequency.
      Consequently, body weight will be reduced. It is also expected that food craving be
      decreased, cognitive performance be enhanced, and neurobiological markers be improved.
    

Intervention name(s): TMS
Intervention type(s): Device
Intervention description(s): Transcranial Magnetic Stimulation has developed into a powerful tool that utilizes magnetic fluxes to non-invasively stimulate the human cortex. The technique involves placement of a small coil over the scalp; passing a rapidly alternating current through the coil wire, which produces a magnetic field that passes unimpeded through the scalp and bone, resulting in electrical stimulation of the cortex.
Other intervention name(s): Repetitive Transcranial Magnetic Stimulation; Transcranial Magnetic Stimulation; rTMS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Repetitive transcranial magnetic stimulation applied to people with binge eating disorder (real x sham stimulation) only (not for control groups without binge eating disorder)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Binge Eating; Obesity; TMS; Neuroimage; Neuromodulation; Biomarkers; Eating Disorders; Cognition; Endocrine; Hormones; BDNF; Inflammatory biomarkers