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

U

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

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

Trial contacts and locations

1

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Central trial contact

Ljubica Konstantinovic

Data sourced from clinicaltrials.gov

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