Repetitive Transcranial Magnetic Stimulation in Treatment of Binge Eating Disorder. A Double Blind Placebo Controlled Study

The study was realized at Department of Psychiatry First Faculty of Medicine Charles University in Prague and General University Hospital in Prague during 2013 - 2018. The study was approved by the Ethics committee General University Hospital in Prague by a decision dated 23.1.2014, number 1867/13 S-IV (individual research). The study was registered on clinicaltrials.gov.

Two psychiatrists examined each patient who signed up for the study, in order to set the diagnoses. The DSM-5 diagnostic criteria were used for the purpose of the study. The exclusion criteria were mainly based upon contraindications for rTMS such as: a history of epileptic seizure paroxysms, increased intracranial pressure, brain tumor, implanted metal devices in the cranium (except the oral cavity), and any implanted peacemaker or drug pump. Also, patients who were not able to complete 10 sessions of rTMS were excluded for non-compliance. Inclusion criteria were: having BED and being over the age of 18. The study did not account for the hemispherical laterality.

After signing an informed consent form, subjects were included into the study and randomly divided into two groups: one group stimulated by a real rTMS coil (group A - active), and the second (control group), stimulated by a sham rTMS coil (group P - placebo).

Patients were also offered to participate in cognitive behavioral group therapy (CBT) simultaneously with the rTMS treatment. However, the attendance in the CBT was voluntary, and it was not a condition for inclusion into the study.

The study was conceived as randomized double blind placebo controlled clinical study. The randomization was performed by statistics independent of study. The investigators group achieved the study´s double blind characteristics by dividing the roles of the researchers. One author provided the examinations of the patients, CBT, data collection and evaluations of the questionnaires, while a second author administered the stimulations. The control group was "blind" thanks to the use of the sham coil.