Quantitative EEG Changes Following Repetitive Transcranial Magnetic Stimulation in Patients With Post Stroke (EEG-rTMS)

Study Overview
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Brief Summary
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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.

Detailed Description
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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?

Official Title
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Examination of Changes in Quantitative EEG Parameters Based on Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Patients With Post Stroke

Conditions
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Stroke, Stroke, Ischemic, Stroke/Brain Attack

Intervention / Treatment
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* Device: repetitive Transcranial Magnetic Stimulation (rTMS)
* Other: 32 electrode electroencephalography (EEG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhibitory repetitive Transcranial Magnetic Stimulation<br>All patients will receive inhibitory repetitive transcranial magnetic stimulation (rTMS) treatment at 1 Hz frequency. The contralesional primary motor cortex region will be stimulated with a Neurosoft-Neuro MS/D device. There will be a total of 10 treatment sessions over a 2-week period. Before each intervention, the resting motor threshold (rMT) value will be determined. rMT will be detected by obtaining a motor-evoked potential of >50 μV amplitude on EMG recording of the contralateral first dorsal interosseous muscle in at least 5 out of 10 stimulations to the primary motor cortex. 90% of the motor threshold will be set in the stimulation. Each stimulation is planned for a total of 20 minutes and a total of 1200 pulses in the form of 1 Hz stimulation. | Device: repetitive Transcranial Magnetic Stimulation (rTMS)<br>* Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive intervention that uses magnetic fields to stimulate nerve cells to improve the symptoms of a variety of disorders, including stroke-related motor impairment. Last few decades, it has been revealed that rTMS accelerates motor recovery and may reduce stroke-related symptoms.<br>Other: 32 electrode electroencephalography (EEG)<br>* 32-electrode EEG will be non-invasively recorded from electrodes placed in a montage over the scalp while the participant is resting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in The Fugl-Meyer Assessment (FMA) | 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. | (1) Baseline, (2) At the end of the last session of the intervention (immediately after the 10th session, each session is 1 day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Modified Ashworth Scale | The modified Ashworth Scale is a clinical index that used for assessment of muscle tone and evaluates the resistance occuring during passive range of motion. | (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 Brunnstrom Stages of Stroke Recovery | The Brunnstrom stages are a clinical scale that describe the changes in the ability of movement and the development and reorganization of brain at the post-stroke stage. | (1) Baseline, (2) At the end of the last session of the intervention (immediately after the 10th session, each session is 1 day) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post Stroke, Repetitive Transcranial Magnetic Stimulation, Motor Recovery, quantitative EEG, Electroencephalogram, biomarkers