An interventional study of Treatment with EXOMIND (BTL-699-2) in Brain Electrical Reactivity to BTL-699-2 Stimulation, sponsored by BTL Industries Ltd.. Completed at 1 site in Czechia. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by BTL Industries Ltd. · Not applicable, Interventional, and Treatment
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:
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.
BTL Industries Ltd. is the lead sponsor of 71 studies on the registry; 4 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
any medication that may alter EEG report (such as benzodiazepines, barbiturates, carbamazepine, valproate, phenothiazines, clozapine, tricyclic antidepressants, lithium, etc.), any other disease or condition at the investigator discretion that may pose risk to the patient or compromise the study
Transcranial magnetic stimulation with the EXOMIND (BTL-699-2) device
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.
Also known as: EXOMIND (BTL-699-2) with ExoTMS
Assessment of Eletrical Reactivity using EEG
The primary outcome is the comparison of changes in EEG power spectral density (PSD) within specific regions for each stimulation location, as well as a comparison of these results between different stimulation locations. These analyses will be performed across all measured participants. EEG measurement will be performed after the stimulation of each location.
Time frame: 12 months
Assessment of Therapy Comfort
Therapy Comfort Questionnaire will be used for evaluating the comfort during the treatment sessions. The Therapy Comfort questionnaire will be administered after the stimulation of each location. Therapy Comfort questionnaire consists of the question "I found the treatment comfortable", to which responses are based on a 5-point Likert scale (1 = "strongly disagree", and 5 = "strongly agree"). A higher score for the statement "I found the treatment comfortable" indicate higher therapy comfort.
Time frame: 12 months
Assessment of Pain During Therapy
The Therapy Comfort Questionnaire will be used to evaluate pain experienced during the treatment session. It will be administered after the stimulation of each location. The questionnaire includes a 10-point Numeric Analog Scale for pain (0 = no pain, 10 = worst possible pain). Lower scores on the Numeric Analog Scale indicate lower levels of pain.
Time frame: 12 months
Incidence of Treatment-related Adverse Events
Monitoring of adverse reactions and side effects will be performed to identify side effects and adverse events associated with the treatment using the BTL-699-2 device.
Time frame: 12 months
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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BTL Industries Ltd.