Clinical trial NCT02747914: Repetitive Transcranial Magnetic Stimulation for Lower Limb Spasticity in Multiple Sclerosis Patients
Official title: Repetitive Transcranial Magnetic Stimulation Boosted Exercise Therapy for Lower Limb Spasticity in Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: muscle tone measured by Modified Ashworth Scale (MAS)
timeFrame: 3 weeks
Secondary outcomes:
measure: impact of leg spasticity on daily activities measured by Multiple Sclerosis Spasticity Scale 88 (MSSS-88)
timeFrame: 3 weeks
measure: Activities of daily living measured by Barthel Index
timeFrame: 3 weeks
measure: Walking mobility measured by Timed 25 Foot Walk test
timeFrame: 3 weeks
measure: Quality of life measured by Multiple Sclerosis Quality of Life 54 (MSQoL54).
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade
Study officials:
References: