Effectiveness of TMS on Spasticity and Balance for Patients With MS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: rTMS, sham rTMS.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Transcranial Magnetic Stimulation on Spasticity and Balance in Patients Diagnosed With Multiple Sclerosis
Overview
Recently, non-invasive brain stimulation modalities such as transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation have become treatment options. Among these methods, rTMS is a non-invasive brain stimulation technique that can affect descending corticospinal pathways, thereby modulating cortical excitability in the motor area where it is applied. This study will examine the effect of rTMS application on spasticity and balance in patients with multiple sclerosis. In addition, the indirect effects of the applications on gait pattern, joint range of motion, and pain will be evaluated.
Interventions
- Device rTMS
Low frequency rTMS application on M1 cortex - Device sham rTMS
Low frequency sham rTMS
Primary outcome measures
- Modified Ashworth Scale [Time frame: patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month]
- Penn Spasm Frequency Scale [Time frame: patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month]
- Modified Tardieu Scale [Time frame: patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month]
- BERG Balance Scale [Time frame: patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month]
- Goal Attainment Scale [Time frame: patients will be checked on first day of hospitalization and after treatment 1 month]
Secondary outcome measures (5)
- Visual Analogue Scale (VAS) [Time frame: patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month]
- Expanded Disability Status Scale (EDSS) [Time frame: patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month]
- Functional Independence Measure (FIM) [Time frame: patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month]
- Multiple Sclerosis Quality of Life-54 (MSQoL-54) [Time frame: patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month]
- Six Minute Walk Test [Time frame: patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month]
Eligibility criteria
Inclusion criteria
- Being between the ages of 18 and 60
- Having been diagnosed with multiple sclerosis for more than six months
- Having spasticity levels between 1 and 3 on the Modified Ashworth Scale (MAS) in the evaluated extremity
- Having an EDSS SCORE between 0 and 6.5
- Voluntarily participating in the study
Exclusion criteria
- Poor general health (heart failure, COPD, etc.)
- Presence of wound lesions on the skin
- Presence of metal implants in the body
- Pregnancy
- Presence of a severe infection
- Diagnosis of malignancy
- Presence of a bleeding disorder
- Use of a pacemaker
- Presence of cardiac rhythm disorder
- Presence of neurological disease other than multiple sclerosis
- History of epilepsy
- History of alcohol use
- Change in medication within the last 6 months
- Refusal to participate in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Ankara Etlik City Hospital — Ankara
Publications
- Zhou X, Li K, Chen S, Zhou W, Li J, Huang Q, Xu T, Gao Z, Wang D, Zhao S, Dong H. Clinical application of transcranial magnetic stimulation in multiple sclerosis. Front Immunol. 2022 Sep 5;13:902658. doi: 10.3389/fimmu.2022.902658. eCollection 2022. PMID 36131925
- Boutiere C, Rey C, Zaaraoui W, Le Troter A, Rico A, Crespy L, Achard S, Reuter F, Pariollaud F, Wirsich J, Asquinazi P, Confort-Gouny S, Soulier E, Guye M, Pelletier J, Ranjeva JP, Audoin B. Improvement of spasticity following intermittent theta burst stimulation in multiple sclerosis is associated with modulation of resting-state functional connectivity of the primary motor cortices. Mult Scler. PMID 27481208
- San AU, Yilmaz B, Kesikburun S. The Effect of Repetitive Transcranial Magnetic Stimulation on Spasticity in Patients with Multiple Sclerosis. J Clin Neurol. 2019 Oct;15(4):461-467. doi: 10.3988/jcn.2019.15.4.461. PMID 31591833
Identifiers
NCT: NCT07451600 · AEŞH-EK-2025-143