EEG Changes After rTMS Stimulation
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
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Prague
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Prague, Prague, Czechia, 162 00
- DP Neuro s.r.o.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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,
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment with EXOMIND (BTL-699-2)
Transcranial magnetic stimulation with the 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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of Therapy Comfort
Time Frame: 12 months
|
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.
|
12 months
|
|
Assessment of Pain During Therapy
Time Frame: 12 months
|
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.
|
12 months
|
|
Incidence of Treatment-related Adverse Events
Time Frame: 12 months
|
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.
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BTL-699_CTCZ300
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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