EEG Changes After rTMS Stimulation

BTL

Status

Enrolling

Conditions

Brain Electrical Reactivity to BTL-699-2 Stimulation

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT07179224

BTL-699_CTCZ300

Details and patient eligibility

About

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

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

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.