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

University of Belgrade

Status: Suspended

Conditions: Multiple Sclerosis

Treatments: Other: Conventional exercise; Device: Transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02747914

LK-5

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Transcranial magnetic stimulation therapy

Experimental group

Description:

Group of patients treated with rTMS low than 5Hz

Treatment:

Device: Transcranial magnetic stimulation

Conventional exercise treatment

Active Comparator group

Description:

Group of patients treated with conventional exercise

Treatment:

Other: Conventional exercise