NCT02747914

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
4.8 years until next milestone

Study Start

First participant enrolled

January 25, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

4.9 years

First QC Date

April 18, 2016

Last Update Submit

May 7, 2024

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • muscle tone measured by Modified Ashworth Scale (MAS)

    3 weeks

Secondary Outcomes (4)

  • impact of leg spasticity on daily activities measured by Multiple Sclerosis Spasticity Scale 88 (MSSS-88)

    3 weeks

  • Activities of daily living measured by Barthel Index

    3 weeks

  • Walking mobility measured by Timed 25 Foot Walk test

    3 weeks

  • Quality of life measured by Multiple Sclerosis Quality of Life 54 (MSQoL54).

    3 weeks

Study Arms (2)

Transcranial magnetic stimulation therapy

EXPERIMENTAL

Group of patients treated with rTMS low than 5Hz

Device: Transcranial magnetic stimulation

Conventional exercise treatment

ACTIVE COMPARATOR

Group of patients treated with conventional exercise

Other: Conventional exercise

Interventions

Transcranial magnetic stimulationDEVICE

TMS 1Hz under the motor zone of cortex.

Transcranial magnetic stimulation therapy
Conventional exerciseOTHER

Exercise will be administrated in a conventional way.

Conventional exercise treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years ≥age of the patient ≤ 65. years

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Belgrade, 11000, Serbia

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 18, 2016

First Posted

April 22, 2016

Study Start

January 25, 2021

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

May 9, 2024

Record last verified: 2024-05

Locations

SE(1)