NCT07056036

EXOMIND (BTL-699-2) for the Improvement in Willpower & Food Cravings

Safety and Efficacy of BTL-699-2 for the Improvement in Willpower, Self-control & Food Cravings

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (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 ExoMIND (BTL-699-2) device is able to improve willpower, self-control and food cravings in adults above the age of 22 years. The main question it aims to answer is: Does the treatment with EXOMIND (BTL-699-2) device improve willpower, self-control and food cravings? Participants will be asked to: * Undergo six treatments * Complete the Brief Self-control Scale * Complete the Food Cravings Questionnaire - Trait * Complete the Therapy Comfort Questionnaire * Complete the Subject Satisfaction Questionnaire

Detailed description

This study uses a prospective, multi-center, two-arm, sham-controlled, single-blinded interventional study design. The subjects will be enrolled and assigned to two experimental study arms: the active group (Group A) and the sham group (Group B), in a ratio of 3:1. All enrolled participants will be treated (either active or sham) with the BTL-699-2 device. Group A will receive rTMS treatment with an intensity of up to 70% of their MT, while Group B will receive rTMS treatment with an intensity of 5% of their MT. Six (6) treatments will be delivered, 3-7 days apart. Examination for possible adverse effects will be conducted after each treatment. The Brief Self-Control Scale and the Food Cravings Questionnaire - Trait (FCQ-T) will be administered to the subjects before the first treatment, after the last treatment, and at the two follow-up visits-1 month and 3 months after the final session. The Therapy Comfort Questionnaire will be administered after the last treatment, while the Subject 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 five months.

Conditions

• Self-Control
• Food Cravings

Interventions

Type	Name	Description
DEVICE	ActiveTreatment with BTL-699-2	Participants will receive six transcranial magnetic stimulation treatments with the BTL-699-2 device over the left dorsolateral prefrontal cortex. The intensity will be adjusted according to the subject's feedback, up to 70% of the individual's motor threshold. The treatments will be spaced 3 - 7 days apart.
DEVICE	Sham Treatment with BTL-699-2	Participants will receive six transcranial magnetic stimulation treatments with the BTL-699-2 device over the left dorsolateral prefrontal cortex. The intensity will se to 5% of the individual's motor threshold. The treatments will be spaced 3 - 7 days apart.

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-10-10
• Completion: 2025-10-10
• First posted: 2025-07-09
• Last updated: 2025-12-10

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study