Back to resultsRepetitive Transcranial Magnetic Stimulation for Lower Limb Spasticity in Multiple Sclerosis Patients
Primary Purpose
Multiple Sclerosis
Status
Recruiting
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
Transcranial magnetic stimulation
Conventional exercise
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
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).
Sites / Locations
- Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of BelgradeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Transcranial magnetic stimulation therapy
Conventional exercise treatment
Arm Description
Group of patients treated with rTMS low than 5Hz
Group of patients treated with conventional exercise
Outcomes
Primary Outcome Measures
muscle tone measured by Modified Ashworth Scale (MAS)
Secondary Outcome Measures
impact of leg spasticity on daily activities measured by Multiple Sclerosis Spasticity Scale 88 (MSSS-88)
Activities of daily living measured by Barthel Index
Walking mobility measured by Timed 25 Foot Walk test
Quality of life measured by Multiple Sclerosis Quality of Life 54 (MSQoL54).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02747914
Brief Title
Repetitive Transcranial Magnetic Stimulation for Lower Limb Spasticity in Multiple Sclerosis Patients
Official Title
Repetitive Transcranial Magnetic Stimulation Boosted Exercise Therapy for Lower Limb Spasticity in Multiple Sclerosis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Belgrade
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transcranial magnetic stimulation therapy
Arm Type
Experimental
Arm Description
Group of patients treated with rTMS low than 5Hz
Arm Title
Conventional exercise treatment
Arm Type
Active Comparator
Arm Description
Group of patients treated with conventional exercise
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation
Intervention Description
TMS 1Hz under the motor zone of cortex.
Intervention Type
Other
Intervention Name(s)
Conventional exercise
Intervention Description
Exercise will be administrated in a conventional way.
Primary Outcome Measure Information:
Title
muscle tone measured by Modified Ashworth Scale (MAS)
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
impact of leg spasticity on daily activities measured by Multiple Sclerosis Spasticity Scale 88 (MSSS-88)
Time Frame
3 weeks
Title
Activities of daily living measured by Barthel Index
Time Frame
3 weeks
Title
Walking mobility measured by Timed 25 Foot Walk test
Time Frame
3 weeks
Title
Quality of life measured by Multiple Sclerosis Quality of Life 54 (MSQoL54).
Time Frame
3 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ljubica Konstantinovic
Phone
063323996
Email
ljubica.konstantinovic@med.bg.ac.rs
Facility Information:
Facility Name
Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ljubica M Konstantinovic, PhDMD
Phone
+381112061513
Email
ljubica.konstantinovic@med.bg.ac.rs
12. IPD Sharing Statement
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Repetitive Transcranial Magnetic Stimulation for Lower Limb Spasticity in Multiple Sclerosis Patients
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