NCT06889298

EXOMIND (BTL-699) for the Reduction of Food Cravings

Safety and Efficacy of the BTL-699 Device for Temporary Reduction of Food Cravings

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (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 BTL-699 device is able to temporarily reduce food cravings in adults above the age of 22 years. The main question it aims to answer is: Does the treatment with BTL-699 device provide a temporary reduction of food cravings? Participants will be asked to: * Undergo 4 to 6 treatments * Undergo weight measurements * Complete the Food Cravings Questionnaire-Trait * Complete the Therapy Comfort Questionnaire * Complete the Satisfaction Questionnaire

Detailed description

This study uses a single-center, single-arm, open-label, interventional design. Subjects reporting at least 3 to 5 weekly instances of food cravings will be enrolled. All enrolled participants will receive 4 to 6 treatments with the BTL-699 device, administered 2 to 3 days apart. The required number of treatments for each participant will be determined on a case-by-case basis by the Principal Investigator, with a minimum of four sessions. Therapy parameters will be adjusted based on patient feedback and comfort, up to 100% of the individual's motor threshold. Examination for possible adverse effects will be assessed at each visit. The Food Cravings Questionnaire-Trait will be administered before the first treatment, after the last treatment, and at the two follow-up visits-2 weeks and 1 month 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 both follow-up visits. The total expected duration of subject participation, from the baseline visit to study completion, is approximately three months.

Conditions

• Food Cravings

Interventions

Type	Name	Description
DEVICE	Treatment with BTL-699	Four to six transcranial magnetic stimulation treatments with the BTL-699 device will be delivered over the left dorsolateral prefrontal cortex, spaced 2 to 3 days apart. The intensity will be adjusted according to the subject's feedback, up to 100% of the individual's motor threshold.

Timeline

• Start date: 2023-02-09
• Primary completion: 2023-06-20
• Completion: 2023-06-20
• First posted: 2025-03-21
• Last updated: 2025-09-17

Locations

1 site across 1 country: Czechia