NCT06899646

EXOMIND (BTL-699-2) for Improvement of Mental Well-being

Safety and Efficacy of BTL-699-2 for Improvement of Mental Well-being

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (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 mental well-being 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 mental well-being? Participants will be asked to: * Undergo four treatments * Complete the Warwick Edinburgh Mental Well-being Scale * Complete the Therapy Comfort Questionnaire * Complete the Subject Satisfaction \& Mental Wellness Questionnaire

Detailed description

The study uses a multi-center, single-arm, open-label, interventional study design. The subjects will be enrolled and assigned to one experimental study arm. All enrolled participants will receive four treatment visits, 5-10 days apart. The Warwick Edinburgh Mental Well-being Scale (WEMWBS) 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 \& Mental Wellness 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

• Well-Being, Psychological

Interventions

Type	Name	Description
DEVICE	Treatment with BTL-699-2	Four transcranial magnetic stimulation treatments with the BTL-699-2 device will be delivered over the left dorsolateral prefrontal cortex, spaced 5 to 10 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: 2024-07-08
• Primary completion: 2025-02-03
• Completion: 2025-02-03
• First posted: 2025-03-28
• Last updated: 2025-07-21

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study