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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02747914
• Other study ID #: LK-5
• Status: Suspended
• Phase: N/A
• Start date: January 25, 2021
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: University of Belgrade
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• Transcranial magnetic stimulation
TMS 1Hz under the motor zone of cortex.

Other:
• Conventional exercise
Exercise will be administrated in a conventional way.

Locations

Country	Name	City	State
Serbia	Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle tone measured by Modified Ashworth Scale (MAS)		3 weeks
Secondary	impact of leg spasticity on daily activities measured by Multiple Sclerosis Spasticity Scale 88 (MSSS-88)		3 weeks
Secondary	Activities of daily living measured by Barthel Index		3 weeks
Secondary	Walking mobility measured by Timed 25 Foot Walk test		3 weeks
Secondary	Quality of life measured by Multiple Sclerosis Quality of Life 54 (MSQoL54).		3 weeks