Repetitive Transcranial Magnetic Stimulation for Lower Limb Spasticity in Multiple Sclerosis Patients

Study Overview
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Brief Summary
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Leg spasticity is common problem encountered with a large proportion of patients suffering with multiple sclerosis (MS) with an increasing severity as the disease progresses. It mostly affects the antigravity muscles that significantly complicates transfer, increases fatigue and makes walking more difficult. Hence, leg spasticity often interferes with patients' mobility and significantly influences their quality of life. A great number of multidisciplinary rehabilitation studies has shown a significant effect of numerous specific functional changes in patients with secondary (SP) and primary progressive (PP) MS but there are no reviews related to spasticity. The positive therapeutic effect of modulating Transcranial Magnetic Stimulation ( TMS) methods on spasticity is shown in only two studies, in patients with relapse remitting clinical form in the remission phase of the disease. The effect of TMS on clinical measures of lower limb spasticity, functional inability and the quality of life in patients with SPMS and PPMS will be examined in this study. The objective to this study are to to explore whether rTMS boosted exercise therapy (ET) treatment can bring more improvement in lower limb spasticity than ET treatment alone in these patients.

Official Title
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Repetitive Transcranial Magnetic Stimulation Boosted Exercise Therapy for Lower Limb Spasticity in Multiple Sclerosis Patients

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Device: Transcranial magnetic stimulation
* Other: Conventional exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed clinical form of SPMS and PPMS (established on the basis of the revised McDonald criteria) EDDS score 2-6.5 lower limb spasticity caused by MS 18 years ≥age of the patient ≤ 65. years Exclusion Criteria: clinical worsening of the disease over the past 30 days, the presence of pregnancy, dementia, alcoholism, history of loss of consciousness, epilepsy, metal objects in the head, pacemakers and other electronic devices in the body at a distance of 20cm from the top of the patients head, serious associate diseases (malignancy, heart disease).
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcranial magnetic stimulation therapy<br>Group of patients treated with rTMS low than 5Hz | Device: Transcranial magnetic stimulation<br>* TMS 1Hz under the motor zone of cortex.<br>|
| Active Comparator: Conventional exercise treatment<br>Group of patients treated with conventional exercise | Other: Conventional exercise<br>* Exercise will be administrated in a conventional way.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle tone measured by Modified Ashworth Scale (MAS) |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| impact of leg spasticity on daily activities measured by Multiple Sclerosis Spasticity Scale 88 (MSSS-88) |  | 3 weeks | 
| Activities of daily living measured by Barthel Index |  | 3 weeks | 
| Walking mobility measured by Timed 25 Foot Walk test |  | 3 weeks | 
| Quality of life measured by Multiple Sclerosis Quality of Life 54 (MSQoL54). |  | 3 weeks |