Multiple SclerosisNCT02747914
Repetitive Transcranial Magnetic Stimulation for Lower Limb Spasticity in Multiple Sclerosis Patients
A study testing Transcranial magnetic stimulation and Conventional exercise in people with Multiple Sclerosis, run by University of Belgrade at 1 site in Serbia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Transcranial magnetic stimulation and Conventional exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSerbia
- Study dates
- 25 Jan 2021to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade
Belgrade, 11000
About this study
Official title: 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Transcranial magnetic stimulation, Conventional exercise
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulationDevice
TMS 1Hz under the motor zone of cortex.
Conventional exerciseOther
Exercise will be administrated in a conventional way.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial magnetic stimulation therapy | Experimental | Group of patients treated with rTMS low than 5Hz Receives: Device: Transcranial magnetic stimulation |
| Conventional exercise treatment | Active comparator | Group of patients treated with conventional exercise Receives: Other: Conventional exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle tone measured by Modified Ashworth Scale (MAS)
Measured: 3 weeks
Secondary outcomes (4)
impact of leg spasticity on daily activities measured by Multiple Sclerosis Spasticity Scale 88 (MSSS-88)
Measured: 3 weeks
Activities of daily living measured by Barthel Index
Measured: 3 weeks
Walking mobility measured by Timed 25 Foot Walk test
Measured: 3 weeks
Quality of life measured by Multiple Sclerosis Quality of Life 54 (MSQoL54).
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study start25 Jan 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Technical problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinovic Ljubica, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747914
- Sponsor's protocol ID
- LK-5
- Status last verified
- May 2024
- First submitted
- 18 Apr 2016
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation Boosted Exercise Therapy for Lower Limb Spasticity in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT02747914
- Acronym / sponsor ID
- LK-5
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Technical problems
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial magnetic stimulation therapy | Experimental | Device: Transcranial magnetic stimulationGroup of patients treated with rTMS low than 5Hz |
| Conventional exercise treatment | Active comparator | Other: Conventional exerciseGroup of patients treated with conventional exercise |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial magnetic stimulationTMS 1Hz under the motor zone of cortex. | Device | Transcranial magnetic stimulation therapy |
| Conventional exerciseExercise will be administrated in a conventional way. | Other | Conventional exercise treatment |
Primary outcome
muscle tone measured by Modified Ashworth Scale (MAS)
Time frame: 3 weeks
4 secondary outcomes
impact of leg spasticity on daily activities measured by Multiple Sclerosis Spasticity Scale 88 (MSSS-88)
Time frame: 3 weeks
Activities of daily living measured by Barthel Index
Time frame: 3 weeks
Walking mobility measured by Timed 25 Foot Walk test
Time frame: 3 weeks
Quality of life measured by Multiple Sclerosis Quality of Life 54 (MSQoL54).
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation and Conventional exercise in people with Multiple Sclerosis, run by University of Belgrade at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle tone measured by Modified Ashworth Scale (MAS) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.