The Effect Of Transcranial Magnetic Stimulation In Patients With Stroke

Study Overview
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Brief Summary
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This study is aimed to investigate the effect of continuous theta burst stimulation (cTBS) and low frequency repetitive transcranial magnetic stimulation (rTMS) on upper extremity spasticity and functional recovery in patients with chronic ischemic stroke.

Detailed Description
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A sham-controlled double-blind randomized study was undertaken. 20 patients with chronic stroke were randomized into active rTMS group (n=7), active cTBS group (n=7) and sham cTBS group (n=6). In the active rTMS group, 10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and inhibitor rTMS was applied with a frequency of 1 Hz consisting of 1200 pulses for 20 minutes. In the active cTBS group, 10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and cTBS was administered for a total of 600 pulses consisting of 3 burst stimulations of 50 Hz repeated every 200 milliseconds for 40 seconds. Sham cTBS was applied in the same protocol but using sham coil. Within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities under the guidance of a physiotherapist, regardless of which group they were in. Upper Extremity Fugl-Meyer Motor Function Scale, Modified Ashworth Scale (MAS), Functional Independence Measure (FIM), Motor Activity Log-28 (MAL-28) and Brunnstrom upper extremity and hand motor recovery stage were assessed at pre-treatment, post-treatment and follow up at 4 weeks.

Official Title
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The Effect Of Sham Controlled Continuous Theta Burst Stimulation And Low Frequency Repetitive Transcranial Magnetic Stimulation On Upper Extremity Spasticity And Functional Recovery In Patients With Ischemic Stroke

Conditions
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Stroke

Intervention / Treatment
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* Device: Active Repetitive Transcranial Magnetic Stimulation Therapy
* Device: Active Continuous Theta Burst Stimulation Therapy
* Device: Sham Continuous Theta Burst Stimulation Therapy


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 between 18-80 years Mini mental test score ≥ 24 upper limb Brunnstrom recovery stage 3 to 5 upper extremity (elbow, wrist and finger) spasticity level Modified Ashworth Scale (MAS) 1+ to 3 Exclusion Criteria: hemorrhagic stroke history of epilepsy a cardiac pacemaker pregnancy 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 poor general health (due to heart failure, chronic obstructive pulmonary disease, severe infection, etc.) diagnosis of malignancy injections of botulinum toxin in the last 6 months for the affected upper extremity drug or dosage changes of anti-spasticity medications in the last 1 month period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active rTMS group<br>chronic ischemic stroke patients receiving active low frequency repetitive transcranial magnetic stimulation therapy and physical therapy | Device: Active Repetitive Transcranial Magnetic Stimulation Therapy<br>* 10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and inhibitor rTMS was applied with a frequency of 1 Hz consisting of 1200 pulses for 20 minutes. In addition, within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities.<br>* Other names: Rehabilitation Program;|
| Active Comparator: Active cTBS group<br>chronic ischemic stroke patients receiving active continuous theta burst stimulation therapy and physical therapy | Device: Active Continuous Theta Burst Stimulation Therapy<br>* 10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and cTBS was administered for a total of 600 pulses consisting of 3 burst stimulations of 50 Hz repeated every 200 milliseconds for 40 seconds. In addition, within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities.<br>* Other names: Rehabilitation Program;|
| Sham Comparator: Sham cTBS group<br>chronic ischemic stroke patients receiving sham continuous theta burst stimulation therapy and physical therapy | Device: Sham Continuous Theta Burst Stimulation Therapy<br>* 10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and sham cTBS was administered for a total of 600 pulses consisting of 3 burst stimulations of 50 Hz repeated every 200 milliseconds for 40 seconds. In addition, within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities.<br>* Other names: Rehabilitation Program;|

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. | up to 6 weeks | 
| Modified Ashworth Scale | Scale measures muscle tone (spasticity) (min-max:0-4). Higher values represent a worse outcome. | up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Independence Measure | Scale measures level of independence on activities of daily life (min-max: 18-126 points). Self-care part of the motor subscale was used in this study (min-max:6-42 points). Higher values represent a better outcome. | up to 6 weeks | 
| 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. | up to 6 weeks | 
| Brunnstrom Motor Recovery Scale | Scale measures upper extremity and hand motor recovery stages (min-max: 1-6). Higher values represent a better outcome. | up to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Repetitive Transcranial Magnetic Stimulation, Continuous Theta Burst Stimulation, Functional Recovery, Spasticity