EEG Changes After rTMS Stimulation

NCT07179224 | Completed

• 1 other identifier: BTL-699_CTCZ300
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Brain Electrical Reactivity to BTL-699-2 Stimulation

Keywords

ExoTMS; EXOMIND; EEG

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (3)

• Assessment of Therapy Comfort

  12 months

• Assessment of Pain During Therapy

  12 months

• Incidence of Treatment-related Adverse Events

  12 months

Study Arms (1)

Treatment with EXOMIND (BTL-699-2)

EXPERIMENTAL

Transcranial magnetic stimulation with the EXOMIND (BTL-699-2) device

Device: Treatment with EXOMIND (BTL-699-2)

Interventions

Treatment with EXOMIND (BTL-699-2) DEVICE

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

Treatment with EXOMIND (BTL-699-2)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 19 years
• Ability to determine the motor threshold of the participant.
• Willingness to maintain on pre-study psychotherapeutic regime, and prescribed medications at a stable therapeutic dosage for at least 2 months prior to study entry.
• Willingness to comply with study instructions and to return to the clinic for the required visits
• Willingness to undergo EEG examination and proceed with the instructions from the study staff during the measurement
• Women of child-bearing potential are required to use birth control measures during the whole duration of the study

You may not qualify if:

• electronic implants (Implanted stimulator devices in or near the head - rTMS devices are contraindicated for use in patients who have active or inactive implants including device leads, deep brain stimulators, cochlear implants, ocular implants, and vagus nerve stimulators, implanted devices such as cardiac pacemakers, defibrillators, and neurostimulators.),
• metallic, ferromagnetic or other magnetic-sensitive implants/objects in or near the head\*,
• application in the heart area,
• persons with a tendency to seizure (hypotonic, epileptic),
• ongoing anticoagulation therapy,
• ongoing severe or life-threatening condition,
• ongoing renal dialysis therapy or decompensated\*\* renal insufficiency,
• decompensated\* hemorrhagic conditions, blood coagulation disorders, cardiovascular diseases,
• malignant or benign tumour (within 30 cm of the treatment coil),
• fever,
• application over or in the near proximity (within 30 cm of the treatment coil) of tattoos with metallic ink
• pregnancy or nursing
• suicidal tendencies or recent attempt to commit suicide,
• concurrent use of electroconvulsive therapy or vagus nerve stimulation,
• ongoing or recent changes (less than 60 days) in intake doses of any pharmaceutical - products, standalone or in combination, that might lower the threshold of seizure potential,

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (1)

DP Neuro s.r.o.

Prague, Prague, 162 00, Czechia

Location

MeSH Terms

Interventions

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 17, 2025
• Study Start: September 17, 2025
• Primary Completion: October 29, 2025
• Study Completion: October 29, 2025
• Last Updated: March 30, 2026

Record last verified: 2025-09

Locations

CZ (1)