EEG Monitoring of rTMS-Induced Prefrontal Cortex Reactivity in Various rTMS Stimulation Locations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Assessment of Eletrical Reactivity using EEG
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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),
- •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.
结局指标
主要结局
Assessment of Eletrical Reactivity using EEG
时间窗: 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.
Assessment of Eletrical Reactivity using EEG
时间窗: 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.
次要结局
- Assessment of Therapy Comfort(12 months)
- Assessment of Pain During Therapy(12 months)
- Incidence of Treatment-related Adverse Events(12 months)
- Assessment of Therapy Comfort(12 months)
- Assessment of Pain During Therapy(12 months)
- Incidence of Treatment-related Adverse Events(12 months)