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

May 7, 2024 updated by: Konstantinovic Ljubica, University of Belgrade

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
      • Belgrade, Serbia, 11000
        • Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Belgrade

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2021

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

April 21, 2016

First Posted (Estimated)

April 22, 2016

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LK-5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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