rTMS and Conventional Physical Therapy After Stroke

Study Overview
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Brief Summary
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Given previous evidence that non invasive brain stimulation enhances the effects of conventional therapies, this randomized sham-controlled trial with 4-weeks follow-up aimed to determine if the repetitive transcranial magnetic stimulation (rTMS)combined with conventional physical therapy (VRT) would be superior to physical therapy in improving upper limb function and quality of life with chronic stroke individuals.

Official Title
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Efficacy of Coupling Repetitive Transcranial Magnetic Stimulation and Conventional Physical Therapy to Reduce Upper Limb Spasticity in Stroke Patients

Conditions
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Stroke

Intervention / Treatment
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* Device: rTMS
* Behavioral: conventional physical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stroke onset ≥ 6 months; muscle tone at the wrist with a modified Ashworth scale (MAS) score between 1+ and 3; minimum age of 30 years old and maximum age of 75 years; absence of cognitive impairment, as determined by the cut-off scores on the Mini-mental state exam Exclusion Criteria: history of seizure or cerebral aneurism; antispasticity drugs within 6 months before enrollment; previous surgery involving metallic implants; unstable vital signs; other neurological diseases aphasia

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: rTMS<br>The experimental group received rTMS to the primary motor cortex of the unaffected side in 10 sessions, 3 days per week, and conventional physical therapy | Device: rTMS<br>* The subjects were seated in a comfortable chair with head and arm rests. Focal TMS of the motor cortex was performed with a 70-mm figure-8 coil attached to magnetic stimulator stimulation parameters : frequency of 1Hz on the uninjured hemisphere by stroke; 1500 pulses with an intensity of 90% of MT 10 sessions of rTMS, one per day, always before conventional physical therapy<br>Behavioral: conventional physical therapy<br>* The physical therapy program was composed of the activities of flexibility, transfer and posture, strength, coordination, balance, and sensory stimulation. The physical therapy was applied for about 30 minutes, three days per week.<br>|
| Sham Comparator: control<br>The control group received sham stimulation (same area as the experimental group) in 10 sessions, 3 days per week, and conventional physical therapy | Behavioral: conventional physical therapy<br>* The physical therapy program was composed of the activities of flexibility, transfer and posture, strength, coordination, balance, and sensory stimulation. The physical therapy was applied for about 30 minutes, three days per week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Modified Ashworth scale | Modified Ashworth scale (MAS) uses a 6-point scale to score the average resistance to passive movement for each joint. In this study, the tonus of the wrist flexor muscles was tested | at baseline, 1 month and 2 months | 
| change from spinal excitability via Hoffmann reflex of the median nerve | assess the effects of the intervention (rTMS and physical therapy) on spinal excitability as measured by the change The Hmax/Mmax ratio (calculated by dividing the maximal amplitude of the H wave by that of the M wave in median nerve) before (baseline), after treatment and after follow-up | at baseline, 1 month and 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from Fugl-Meyer assessment | The Fugl-Meyer assessment (FMA) is considered the gold standard for evaluating the motor function recovery. It is designed to assess motor functioning, balance, sensation, and joint functioning. It is applied within clinical and in research contexts to determine the disease severity, describe motor recovery, and plan and assess interventions. In the present study, the 33-item of the UL section was employed. The items are rated on 3-point ordinal scale, as follows: 0= unable to perform; 1= partial ability to perform; and 2= near normal ability to perform. The UL subscale evaluates motor function recovery in six domains: flexor and extensor synergies, non-synergic movements, wrist and hand movements, and coordination and speed | at baseline, 1 month and 2 months | 
| change from cortical excitability via single transcranial magnetic stimulation | assess the effects of the intervention (rTMS and physical therapy) on motor cortex excitability as measured by the change in motor evoked potential (using transcranial magnetic stimulation) before and after each session | per-session: at baseline and one hour (after physical therapy) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcranial magnetic stimulation, spasticity, physiotherapy, Rehabilitation