Brain Electrical Reactivity to BTL-699-2 StimulationNCT07179224
EEG Changes After rTMS Stimulation
A study testing Treatment with EXOMIND (BTL-699-2) in people with Brain Electrical Reactivity to BTL-699-2 Stimulation, run by BTL Industries Ltd. at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Electrical Reactivity to BTL-699-2 Stimulation
- What is being tested?
- Treatment with EXOMIND (BTL-699-2)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCzechia
- Study dates
- 17 Sep 2025to 29 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
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- 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,
- ongoing withdrawal conditions from any dependence substance or medication associated with altered seizure risk history,
- a psychotic disorder, including schizoaffective disorder, bipolar disease, or major depression with psychotic features,
- history of primary or secondary tumors in CNS, cerebral aneurysm,
- history of increased intracranial pressure or head trauma with loss of consciousness.
- 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
- rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head (with some exceptions in the mouth - standard amalgam dental fillings, single post dental implants, and dental bridge work. When these objects are present monitor the patient during therapy and have the patient notify the operator of warming or other sensation; cease rTMS treatment in event of warming sensation) or within 30 cm of the treatment coil. (Examples include implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewellery, and hair barrettes) **This term applies to patients with a documented medical history of a decompensated health condition requiring medical treatment and/or medication, yet has not received such treatment and/or medication. Patients who use certain medications only for preventive purposes, without any proven previous health condition failure are not considered contraindicated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EEG Monitoring of rTMS-Induced Prefrontal Cortex Reactivity in Various rTMS Stimulation Locations
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
Read the 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.
- Being tested
- Treatment with EXOMIND (BTL-699-2)
- Keywords
- ExoTMS, EXOMIND, EEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with EXOMIND (BTL-699-2)Device
Also called EXOMIND (BTL-699-2) with ExoTMS
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with EXOMIND (BTL-699-2) | Experimental | Transcranial magnetic stimulation with the EXOMIND (BTL-699-2) device Receives: Device: Treatment with EXOMIND (BTL-699-2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start17 Sep 2025
- Primary completion29 Oct 2025
- Study completion29 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Electrical Reactivity to BTL-699-2 StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- BTL Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179224
- Sponsor's protocol ID
- BTL-699_CTCZ300
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG Monitoring of rTMS-Induced Prefrontal Cortex Reactivity in Various rTMS Stimulation Locations
- ClinicalTrials.gov ID
- NCT07179224
- Acronym / sponsor ID
- BTL-699_CTCZ300
- Keywords
- ExoTMS, EXOMIND, EEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- 29 Oct 2025 (actual)
- Study completion
- 29 Oct 2025 (actual)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with EXOMIND (BTL-699-2) | Experimental | Device: Treatment with EXOMIND (BTL-699-2)Transcranial magnetic stimulation with the EXOMIND (BTL-699-2) device |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with EXOMIND (BTL-699-2)Also: EXOMIND (BTL-699-2) with ExoTMSTranscranial 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. | Device | Treatment with EXOMIND (BTL-699-2) |
Primary outcome
Assessment of Eletrical Reactivity using EEG
Time frame: 12 months
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.
3 secondary outcomes
Assessment of Therapy Comfort
Time frame: 12 months
Assessment of Pain During Therapy
Time frame: 12 months
Incidence of Treatment-related Adverse Events
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with EXOMIND (BTL-699-2) in people with Brain Electrical Reactivity to BTL-699-2 Stimulation, run by BTL Industries Ltd. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Eletrical Reactivity using EEG (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.