Effects of Intermittent Theta Burst Stimulation in Addition to Constraint-Induced Movement Therapy in Stroke Patients

Study Overview
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Brief Summary
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In recent studies, it has been reported that intermittent theta-burst stimulation (iTBS) provides additional benefits when applied in adjunct to the rehabilitation in all stages of stroke (acute, subacute, or chronic). In our study, it was aimed to evaluate the effectiveness of iTBS applied in addition to modified constraint-induced movement therapy (mCIMT). By doing so, we intend to increase patient adherence to neurorehabilitation and decrease the cost of rehabilitation.

Official Title
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Effects of Intermittent Theta Burst Stimulation in Addition to Constraint-Induced Movement Therapy in Stroke Patients

Conditions
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Stroke, Ischemic

Intervention / Treatment
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* Other: Rehabilitation (modified constraint-induced movement therapy)
* Other: non-invasive brain stimulation (intermittent theta-burst stimulation)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First time and unilateral stroke 1-12 months after the incident Getting 24 points or more in Mini Mental Status Examination Being able to stand for 2 minutes without any help by using the upper extremity as a support tool when necessary. Being a low-functioning patient according to the CIMT criteria: a) At least 10 degrees of active wrist extension starting from the angle of full flexion, b) 10 degrees of extension at the metacarpophalangeal and inter-phalangeal joints of at least 2 fingers Exclusion Criteria: those who score more than 2.5 points on the Motor Activity Log-28 scale, who have severe pain in the upper extremity (5 and above on the Visual Analogue Scale) and spasticity (3 and above on the Modified Ashworth Scale), which may affect the treatment, and Those who do not have adequate communication skills. Patients who have visual problems

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iTBS + mCIMT group<br> | Other: Rehabilitation (modified constraint-induced movement therapy)<br>* Modified constraint-induced movement therapy (mCIMT): It is an intervention used to improve functionality and mobility in the more affected upper extremity post-stroke.<br>Other: non-invasive brain stimulation (intermittent theta-burst stimulation)<br>* Intermittent theta-burst stimulation (iTBS): It is a form of repetitive transcranial magnetic stimulation and it increases the facilitation of the motor cortex.<br>|
| Sham Comparator: Sham iTBS+ mCIMT group<br> | Other: Rehabilitation (modified constraint-induced movement therapy)<br>* Modified constraint-induced movement therapy (mCIMT): It is an intervention used to improve functionality and mobility in the more affected upper extremity post-stroke.<br>Other: non-invasive brain stimulation (intermittent theta-burst stimulation)<br>* Intermittent theta-burst stimulation (iTBS): It is a form of repetitive transcranial magnetic stimulation and it increases the facilitation of the motor cortex.<br>|
| Active Comparator: mCIMT group<br> | Other: Rehabilitation (modified constraint-induced movement therapy)<br>* Modified constraint-induced movement therapy (mCIMT): It is an intervention used to improve functionality and mobility in the more affected upper extremity post-stroke.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment-Upper extremity | The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and pain. | 30 minutes | 
| Wolf-Motor Function Test | It is a new time-based method to evaluate upper extremity performance while providing insight into joint-specific and total limb movements | 45 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor Evoked Potentials (MEPs) | MEPs are the electrical signals recorded from the descending motor pathways or from muscles following stimulation of motor pathways within the brain. | 10 minutes |