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

NCT ID: NCT02747914

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-25
• Study Completion Date: 2025-12-31

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Transcranial magnetic stimulation therapy

Group of patients treated with rTMS low than 5Hz

Group Type: EXPERIMENTAL

Transcranial magnetic stimulation

Intervention Type: DEVICE

TMS 1Hz under the motor zone of cortex.

Conventional exercise treatment

Group of patients treated with conventional exercise

Group Type: ACTIVE_COMPARATOR

Conventional exercise

Intervention Type: OTHER

Exercise will be administrated in a conventional way.

Interventions

Transcranial magnetic stimulation

TMS 1Hz under the motor zone of cortex.

Intervention Type: DEVICE

Conventional exercise

Exercise will be administrated in a conventional way.

Intervention Type: OTHER

Eligibility Criteria

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).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Belgrade

OTHER

Sponsor Role: lead

Responsible Party

Konstantinovic Ljubica

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade

Belgrade, , Serbia

Countries

Serbia

Other Identifiers

LK-5

Identifier Type: -

Identifier Source: org_study_id