Impact of the EXOMIND (BTL-699-2) on the Brain Reward Pathway

The goal of this clinical trial is to thoroughly explore and ascertain the mechanism of action of the therapy with the EXOMIND (BTL-699-2) device in the treatment of food cravings (serving as an important precipitant to binge eating episodes), among binge eaters and to confirm its efficacy and safety, in adult binge-eating patients with food cravings. The main question it aims to answer is: To ascertain the mechanism of action of the treatment with the EXOMIND (BTL-699-2) device equipped with a BTL-699-AP-M-2 applicator in reducing food cravings, for the active group only. Participants will complete six treatments and one follow-up visit.

The study is a prospective, single-center, two-arm, randomized controlled trial. The subjects will be enrolled and randomly assigned to an active or sham experimental study arm. The ratio of active:sham groups will be 3:1. The subjects will be required to complete six (6) treatment visits and one (1) follow-up visit, scheduled 1 month post-treatment. At the screening visit, an informed consent will be obtained from the patient, and inclusion and exclusion criteria will be verified. A thorough medical history, review of concomitant medications and psychiatric examination will be performed, mainly focused on possible contraindications, to exclude subjects with a possible confounding condition. A drug and pregnancy test will be performed as part of the exclusion criteria assessment. Additionally, as a part of the inclusion criteria, subjects will be asked to fill out the Food Craving Questionnaire-Trait (FCQ-T) to evaluate the severity of the food cravings. The subject's motor threshold (MT) will be established as a part of the inclusion criteria. Only subjects meeting all inclusion and none of the exclusion criteria will be enrolled, randomized (to a sham or active study group) and invited to baseline visit no later than 14 days after the screening visit. Baseline measurements will include recording the subject's weight and height to calculate their BMI (Body Mass Index). The performed MRI (Magnetic Resonance Imaging) scanning will be divided into collecting structural MRI and fMRI (during the food-cue reactivity task) to obtain pre-treatment data for subsequent analysis. During the baseline fMRI food-cue reactivity task measurement, the EEG (Electroencephalography) of the patients will be also collected. The treatment administration phase consists of six (6) 24.5-minute treatment visits scheduled 3-7 days apart. After all pre-treatment procedures are completed, the first study treatment can be administered during the baseline visit. The BTL-699-AP-M-2 applicator will be positioned to cover the left dlPFC (Dorsolateral Prefrontal Cortex). The therapy parameters will be adjusted according to patient feedback, but should never exceed 70% of the individual's MT in the active group. The sham group will be treated with a 5% intensity of the individual's MT. The treatment area will be examined for possible adverse events after each treatment. After the last treatment, review of concomitant medications will be performed, the subjects will be weighed, asked to undergo pregnancy test, fMRI and fill out the FCQ-T, Subject Satisfaction Questionnaire (SSQ), and Therapy Comfort Questionnaire (TCQ). Structural MRI scans will also be collected before the fMRI scanning to detect any potential abnormalities in the treated area. Additionally, the EEG of the patients will be also collected in the course of the fMRI food-cue reactivity task. Before and after each treatment visit, and at the follow-up visit, an examination for possible adverse effects will be done. The follow-up visit will be scheduled 1 month after the last treatment (±5 days). Review of concomitant medications will be performed, subjects will be weighed and asked to undergo pregnancy test, fMRI, to complete the Subject Satisfaction Questionnaire and FCQ-T. Structural MRI scans will also be collected before the fMRI scanning to detect any potential abnormalities in the treated area. Additionally, the EEG of the patients will be also collected in the course of the fMRI food-cue reactivity task. The study outcomes will be based on exploring the differences in the neural activity post vs. pre-treatment in the active group and comparing the assessments' results of the active group to the sham group.