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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02747914
Recruitment Status : Active, not recruiting
First Posted : April 22, 2016
Last Update Posted : March 24, 2020
Information provided by (Responsible Party):
Konstantinovic Ljubica, University of Belgrade

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: Transcranial magnetic stimulation Other: Conventional exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation Boosted Exercise Therapy for Lower Limb Spasticity in Multiple Sclerosis Patients
Actual Study Start Date : January 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Transcranial magnetic stimulation therapy
Group of patients treated with rTMS low than 5Hz
Device: Transcranial magnetic stimulation
Active Comparator: Conventional exercise treatment
Group of patients treated with conventional exercise
Other: Conventional exercise

Primary Outcome Measures :
  1. muscle tone measured by Modified Ashworth Scale (MAS) [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. impact of leg spasticity on daily activities measured by Multiple Sclerosis Spasticity Scale 88 (MSSS-88) [ Time Frame: 3 weeks ]
  2. Activities of daily living measured by Barthel Index [ Time Frame: 3 weeks ]
  3. Walking mobility measured by Timed 25 Foot Walk test [ Time Frame: 3 weeks ]
  4. Quality of life measured by Multiple Sclerosis Quality of Life 54 (MSQoL54). [ Time Frame: 3 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   No

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).
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Responsible Party: Konstantinovic Ljubica, professor, University of Belgrade Identifier: NCT02747914    
Other Study ID Numbers: LK-5
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases