NCT07179224

EEG Changes After rTMS Stimulation

EEG Monitoring of rTMS-Induced Prefrontal Cortex Reactivity in Various rTMS Stimulation Locations

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: BTL Industries Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to explore the brain's electrical reactivity, monitored using EEG, following the EXOMIND (BTL-699-2) stimulation across various stimulation locations. The main question it aims to answer is: What is the brain's cortical electrical reactivity, monitored using EEG, following the EXOMIND (BTL-699-2) stimulation across various stimulation locations? Participants will be asked to: * Undergo 1 treatment visit * Undergo electroencephalography (EEG) measurements * Complete Therapy Comfort Questionnaires

Detailed description

This is a non-randomized, prospective, single-center, single-arm, open-label, interventional study. All participants will be treated with the EXOMIND (BTL-699-2) device. Before the first stimulation, a resting EEG recording will be performed for 3 minutes with the subjects' eyes closed and 3 minutes with the subjects' eyes open. The treatment administration phase consists of one (1) treatment visit. The intensity will be carefully adjusted based on subject feedback, but it should not exceed 70% of the motor threshold. EEG measurements will be conducted, and the Therapy Comfort Questionnaire will be administered during the treatment visit. The treatment area will be examined for possible adverse events after the stimulation and during both follow-up visits. The safety follow-up visits will be 2 weeks (± 2 days) and 1 month (± 5 days) after the treatment visit. After completing the final follow-up visit (1 month after the treatment visit), the patient's participation in the study will be considered complete. The estimated duration of participation, from the initial visit to the final follow-up, is approximately 2 months.

Conditions

• Brain Electrical Reactivity to BTL-699-2 Stimulation

Interventions

Type	Name	Description
DEVICE	Treatment with EXOMIND (BTL-699-2)	Transcranial magnetic stimulation with the EXOMIND (BTL-699-2) device will be delivered across various stimulation locations. The intensity will be carefully adjusted based on subject feedback, but it should not exceed 70% of the motor threshold.

Timeline

• Start date: 2025-09-17
• Primary completion: 2025-10-29
• Completion: 2025-10-29
• First posted: 2025-09-17
• Last updated: 2026-03-30

Locations

1 site across 1 country: Czechia