Examination of Changes in Quantitative EEG Parameters Based on Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Patients With Post Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in The Fugl-Meyer Assessment (FMA)
研究概览
简要总结
Quantitative EEG (qEEG) has been used as an effective tool in the diagnosis and prognosis of brain-related diseases. In the literature, a variety of qEEG parameters have been proven informative in the prognosis of stroke. In addition, it has been demonstrated that changes in certain qEEG parameters during traditional/task-specific rehabilitation approaches are correlated with clinical outcomes of functional motor recovery. Repetitive transcranial magnetic stimulation (rTMS) has been proposed as a non-invasive and therapeutic treatment used to accelerate and enhance the recovery process of motor function in stroke patients. Many studies have reported that inhibiting contralesional rTMS may have positive effects in stroke patients with severe upper extremity motor impairment. In this context, the aim of the proposed study is to investigate whether there is a correlation between the change in qEEG parameters and the improvement of motor functions associated with rTMS treatment and to provide an electrophysiological prognostic biomarker of inhibiting contralesional rTMS for stroke patients.
详细描述
50 stroke patients will receive inhibiting contralesional rTMS at 1 Hz frequency. Upper extremity motor functions will be assessed with Fugl-Meyer Assessment-Upper Extremities (FMA-UE), Brunnstrom stages, modified Ashworth Scale (MAS) before and after treatment. The resting-state EEGs will be measured six time during the course of the treatment (Before/After 1. Session, Before/After 5. Session, Before/After 10. Session (end of the treatment)).
The main questions it aims to answer are:
50 stroke patients will receive inhibiting contralesional rTMS at 1 Hz frequency. Upper extremity motor functions will be assessed with Fugl-Meyer Assessment-Upper Extremities (FMA-UE), Brunnstrom stages, modified Ashworth Scale (MAS) before and after treatment. The resting-state EEGs will be measured six time during the course of the treatment (Before/After 1. Session, Before/After 5. Session, Before/After 10. Session (end of the treatment)).
The main questions it aims to answer are:
- How do the previously suggested quantitative EEG parameters (decrease in DAR (Delta Alpha power ratio), BSI (Brain Symmetry Index) and DTAB (Delta-theta to alpha-beta ratio, increase in alpha mean frequency ) change with rTMS application for the recovery of motor functions in patients with stroke and can they be defined as an effective biomarker for stroke treatment with rTMS?
- Can the clinical response to rTMS be estimated from the quantitative EEG parameters calculated from just before rTMS application?
- Can electrophysiological effect of rTMS be observed from EEG measurements throughout the application?
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than age of 18 years.
- •Presence of ischemic or hemorrhagic stroke confirmed by MRI.
- •Having a stroke for the first time.
- •Patients who agreed to participate by signing the informed consent form.
排除标准
- •Presence of a clinical condition (metallic implant, cardiac or brain pace, claustrophobia, head trauma, cranial operation history) that may constitute a contraindication to repetitive transcranial magnetic stimulation intervention.
- •Presence of malignancy or systemic rheumatic disease
- •Pregnancy or breastfeeding
- •Non-stroke disease or lesion affecting the sensorimotor system
- •Alcohol or drug addiction
- •Presence of pump/shunt
- •Presence of severe cognitive impairment
- •Presence of >3 spasticity in the upper extremity defined according to the Modified Ashworth Scale
- •History of psychiatric illness such as major depression/personality disorders
- •History of epilepsy or taking medication due to epilepsy
- •Diagnosed with dementia
- •Received rTMS intervention before
结局指标
主要结局
Change in The Fugl-Meyer Assessment (FMA)
时间窗: (1) Baseline, (2) At the end of the last session of the intervention (immediately after the 10th session, each session is 1 day)
The Fugl-Meyer Assessment (FMA) is a clinical stroke-specific scale that an assesment sensorimotor impairment. It is a powerful index applied clinically and also in research to identify the stroke severity, determine the motor recovery and to plan the rTMS interventions.
次要结局
- Change in Brunnstrom Stages of Stroke Recovery((1) Baseline, (2) At the end of the last session of the intervention (immediately after the 10th session, each session is 1 day))
- Change in Modified Ashworth Scale((1) Baseline, (2) At the end of the last session of the intervention (immediately after the 10th session, each session is 1 day))
研究者
Onan Güren
Asst. Prof. Dr.
Izmir Katip Celebi University