The Effects of rTMS and tDCS Copuled With Robotic Therapy In Patients With Stroke

Study Overview
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Brief Summary
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The purpose of this study is to assess the effect of rTMS and tDCS coupled with robotic therapy on upper extremity functional recovery

Detailed Description
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After being informed about study and potential risks, all patient giving written informed consent will undergo screening period determine eligibility for study entry. The patients who meet the eligibility requirements will be randomized into four groups in a 1:1 ratio to active rTMS, sham rTMS, active tDCS and sham tDCS.

Official Title
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The Effects of rTMS and tDCS Copuled With Robotic Therapy on Upper Extremity Functional Recovery in Patients With Chronic Stroke

Conditions
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Chronic Stroke

Intervention / Treatment
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* Other: active rTMS
* Other: sham rTMS
* Other: active tDCS
* Other: sham tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ischemic stroke with a disease interval of 6 months to 2 years aged based 18 years first stroke Mini mental test score ≥ 22 upper extremity (elbow, wrist and finger) spasticity level Modified Ashworth Scale (MAS)≤2 Shoulder, elbow and wrist muscle strength ≥ 2 according to Medical Research Council- MRC Exclusion Criteria: hemorrhagic stroke history of epilepsy a cardiac pacemaker pregnancy Fugl Meyer upper extremity assessment score ≥44 history of previous stroke or ischemic attack neurological diseases other than stroke metallic implant in brain or scalp (including cochlear implant) previous brain surgery orthopedic disease that prevents upper extremity movements diagnosis of malignancy receiving robotic /TMS/tDCS treatments in the last 6 months

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active rTMS<br>Participants recevied 1 Hz low frequency repetetive TMS during 20 minutes and a total of 1200 stimuli for 15 sessions. The patient received robotic therapy for upper extremity just after each active TMS sessions | Other: active rTMS<br>* Participants recevied 1 Hz low frequency repetetive TMS during 20 minutes and a total of 1200 stimuli for 15 sessions. Motor threshold was defined as the minimum stimulus intensity eliciting 5 responses of about 50 µV out of 10 consecutive trials (50% successful MEPS) in the relaxed contralateral abductor pollicis brevis (APB).The patient received robotic therapy for upper extremity just after each active TMS sessions.<br>|
| Sham Comparator: sham rTMS<br>Participants recevied sham TMS during 20 minutes and a total of 1200 sham stimuli for 15 sessions with sham coil. The patient received robotic therapy for upper extremity just after each sham TMS sessions | Other: sham rTMS<br>* Participants recevied sham TMS during 20 minutes and a total of 1200 sham stimuli for 15 sessions with sham coil employed was identical in shape and size to the real stimulation coil and produced no magnetic field. The patient received robotic therapy for upper extremity just after each sham TMS sessions.<br>|
| Experimental: active tDCS<br>Participants recevied 2 mA anodal transcranial direct current stimulation 20 minutes for 15 sessions. The patient received robotic therapy for upper extremity just after each active tDCS sessions | Other: active tDCS<br>* Participants recevied 2 mA anodal transcranial direct current stimulation 20 minutes for 15 sessions.The electrodes will be placed anodal to the C3/C4 (International 10/20 Electroencephalogram System) area, corresponding to the location of the affected hemisphere primary motor cortex (M1), and cathodal to the contralateral supraorbital region. The patient received robotic therapy for upper extremity just after each active tDCS sessions.<br>|
| Sham Comparator: sham tDCS<br>Participants recevied sham stimulation. The patient received robotic therapy for upper extremity just after each sham tDCS sessions | Other: sham tDCS<br>* Participants recevied sham stimulation were applied current was ramped up either over 10 seconds, with an equal amount of time for tapering off. The patient received robotic therapy for upper extremity just after each sham tDCS sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper Extremity Fugl-Meyer Motor Function Scale | Scale measures level of upper extremity motor functions (min-max: 18-126 points). Higher values represent a better outcome. | initial, 3th week 9th week changes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor Activity Log-28 | Scale measures frequency of use and functionality level of the affected upper limb during daily activities (min-max: 0-5 points). Higher values represent a better outcome. | initial, 3th week 9th week changes | 
| Barthel Index | Scale measures performance in activities of daily living. The Index yields a total score out of 100 - the higher the score, the greater the degree of functional independence. | initial, 3th week 9th week changes | 
| Stroke Impact Scale version 3.0 | Scale has 8 domains: strength, hand function, mobility, physical and instrumental activities of daily living, memory and thinking, communication, emotion, and social participation. Scores for each domain range from 0 to 100, and higher scores indicate a better Scores for each domain range from 0 to 100, and higher scores indicate a better. The scale also includes a question (item 50) to assess the patient's global perception of recovery. The respondent is asked to rate his or her percentage of recovery on a visual analog scale of 0 to 100, with 0 meaning no recovery and 100 meaning full recovery. | initial, 3th week 9th week changes | 
| Box and Block Test | The Box and Block Test (BBT) measures unilateral gross manual dexterity. Higher values represent a better outcome. | initial, 3th week 9th week changes | 
| Modified Ashworth Scale | Scale measures muscle tone (spasticity) (min-max:0-4). Higher values represent a worse outcome | initial, 3th week 9th week changes | 
| The amplitude of motor evoked potentials (MEPs) | The amplitude of MEP is a common yet highly variable measure of corticospinal excitability. | initial, 3th week 9th week changes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, rTMS, tDCS, robotic therapy