NCT06894615

EXOMIND (BTL-995) for the Reduction of Binge-eating

Safety and Efficacy of the BTL-995-rTMS Device for the Reduction of Binge-eating

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: BTL Industries Ltd. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluate if the treatment with the BTL-995-rTMS device is able to reduce binge eating in adults above the age of 22 years. The main question it aims to answer is: Whether the treatment with the BTL-995-rTMS device reduces binge eating. Participants will be asked to: * Undergo six treatments * Undergo weight measurements * Complete the Binge Eating Scale * Complete the Therapy Comfort Questionnaire * Complete the Satisfaction Questionnaire

Detailed description

This study uses a single-center, single-arm, open-label, interventional design. Subjects scoring more than 17 points on the Binge Eating Scale will be enrolled and assigned into one experimental study arm. All participants will receive six treatments with the BTL-995-rTMS device, administered 2 to 4 days apart. Therapy parameters will be adjusted based on patient feedback and comfort, up to 70% of the individual's motor threshold. Examination for possible adverse effects will be assessed at each visit. The Binge Eating Scale will be administered before the first treatment, after the last treatment, and at the 1-month follow-up visit after the final session. The Therapy Comfort Questionnaire will be administered after the last treatment, while the Satisfaction Questionnaire will be given after the last treatment and at the follow-up visit.

Conditions

• Binge Eating
• Binge-Eating Disorder

Interventions

Type	Name	Description
DEVICE	Treatment with BTL-995-rTMS	Six transcranial magnetic stimulation treatments with the BTL-995-rTMS device will be delivered over the left dorsolateral prefrontal cortex, spaced 2 to 4 days apart. The intensity will be adjusted according to the subject's feedback, up to 70% of the individual's motor threshold.

Timeline

• Start date: 2023-07-11
• Primary completion: 2023-12-11
• Completion: 2023-12-11
• First posted: 2025-03-25
• Last updated: 2025-09-17

Locations

1 site across 1 country: Czechia