Effectiveness of TMS on Spasticity and Balance for Patients With MS

The Effect of Transcranial Magnetic Stimulation on Spasticity and Balance in Patients Diagnosed With Multiple Sclerosis

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: rTMS; Device: sham rTMS

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melike Çil, specialist; Phone Number: +903122911000 +90 0312 797 00 00; Email: melike9671@gmail.com

Study Locations

• Turkey (Türkiye)
  • Yenimahalle
    • Ankara, Yenimahalle, Turkey (Türkiye), 06010
      • Recruiting
      • Ankara Etlik City Hospital
      • Contact: Melike Çil, specialist; Phone Number: +90 0312 797 0000; Email: melike9671@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: rTMS M1; rTMS application on M1 cortex	Device: rTMS; Low frequency rTMS application on M1 cortex
Placebo Comparator: sham rTMS; sham rTMS application on M1 cortex	Device: sham rTMS; Low frequency sham rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Ashworth Scale	It is designed to determine the level of spasticity. Accordingly, 0: no increase in muscle tone, 1: minimal resistance at the end of joint range of motion or a slight increase in muscle tone manifested as catching and releasing, 1+: increase in muscle tone characterized by minimal resistance developing over a smaller portion of the last half of joint range of motion, 2: increase in muscle tone that is noticeable but does not allow joint movement over a large portion of joint range of motion, allows joint movement, 3: Increased muscle tone that impedes passive movement, 4: Joint is rigid in flexion or extension. Spasticity in the patients' lower extremity muscles will be assessed.	patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month
Penn Spasm Frequency Scale	It is a measure that determines the frequency of spasms. Spasm frequency is rated on a 5-point scale: Spasm Frequency Spasm Severity 0: No spasms, 1: Mild spasms induced by stimulation, 2: Complete spasms occurring less than once per hour, 3: Spasms occurring more than once per hour, 4: Spasms occurring more than ten times per hour.	patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month
BERG Balance Scale	It is a scale consisting of 14 guidelines, with the patient's performance observed for each guideline and scored on a scale of 0-4. A score of 0 is given when the patient is unable to perform the activity at all, while a score of 4 is given when the patient completes the activity independently. The maximum score is 56, with 0-20 points indicating balance impairment, 21-40 points indicating acceptable balance, and 41-56 points indicating good balance.	patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month
Modified Tardieu Scale	Muscle tone is assessed at 5 degrees at predetermined speeds. The first angle at which increased resistance is detected in the joint is recorded. It is compared to the angle when the range of motion is complete. 0: No resistance during passive movement, 1: Mild resistance during passive movement but no catching sensation at any specific angle, 2: Passive movement is interrupted at a specific angle with a catching sensation, followed by relaxation, 3: Resistance continues, movement is interrupted at a specific angle with a catching sensation, followed by relaxation, 3: When pressure is maintained, fatigue occurs at a specific angle for less than 10 seconds, causing clonus lasting more than 10 seconds at a specific angle when pressure is maintained, Unassessable: Inconsistent measurements or the absence of relaxation after a catching sensation at different angles is considered. modified Tardieu scores will be recorded for the hamstring and gastrocnemius	patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month
Goal Attainment Scale	It allows for the assessment and measurement of individualized, predefined goals on a 5-point scale ranging from -2 to +2. In this study, the extent to which spasticity in the muscle group with the highest spasticity at baseline and at the 1-month follow-up changed from the MAS to the GAS was evaluated.; 2: Increase in MAS score compared to the initial examination; 1: MAS score remains the same as in the initial examination 0: Decrease of 1 unit in the MAS score compared to the initial examination1: Decrease of 2 units in the MAS score compared to the initial examination2: Decrease of 3 units or more in the MAS score compared to the initial examination	patients will be checked on first day of hospitalization and after treatment 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS)	This is a scale used to assess patients' pain levels. It is rated on a scale of 0 to 10 points. A score of 0 indicates no pain, while a score of 10 reflects the most severe pain ever experienced.	patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month
Expanded Disability Status Scale (EDSS)	Multiple Sclerosis (MS) patients It is a measure used to assess the level of physical disability caused by the disease. Based on neurological examination findings, it allows for objective monitoring of the course of the disease and functional status. EDSS Assessment Criteria:. 0.0 - 3.5: Minimal or mild disability. The patient's ability to walk is not affected, but there may be mild problems in some functional systems (e.g., vision, sensation, coordination). . 4.0 - 5.5: Moderate disability. The patient feels a significant limitation in their walking capacity, but can usually walk short distances without assistance.. 6.0 - 7.5: More severe walking difficulties. The patient requires assistive devices (e.g., cane, walker) or can only walk short distances without assistance.. 8.0 - 9.5: Bed or wheelchair dependency. The patient is mostly unable to meet their own needs independently.. 10.0: Death, due to causes directly related to MS.	patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month
Functional Independence Measure (FIM)	It is a measure used to determine individuals' independence levels by assessing their physical, psychosocial, and social skills. It is widely used to monitor the independence level of patients, especially during the rehabilitation process. It contains a total of 18 items: 13 items assess motor skills, and 5 items assess social and cognitive skills. Each item is scored from 1 to 7. The total score range varies from 18 (completely dependent) to 126 (completely independent).	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)	It consists of 54 questions, and the scale is evaluated based on the answers to questions related to changes in health status, physical functions, general health perception, energy/fatigue, physical role limitations, pain, sexual functions, sexual life satisfaction, social functions, health-related concerns, overall quality of life, emotional well-being, emotional role limitations, and cognitive functions. The results are then used to calculate the physical health status average, cognitive health status average, and MSQOL-54 total score.	patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month
Six Minute Walk Test	It is a practical test used to determine an individual's functional capacity. The test involves walking on a flat surface for 6 minutes according to a standardized protocol. The distance walked within 6 minutes is evaluated using this method.	patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month

Collaborators and Investigators

• Sponsor: Ankara Etlik City Hospital
• Investigators: Study Director: Özgür Zeliha Karaahmet, professor, Ankara Etlik City Hospital

Publications and helpful links

General 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.
• 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. 2017 May;23(6):855-863. doi: 10.1177/1352458516661640. Epub 2016 Aug 1.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Balance; Spasticity; TMS
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscle Spasticity; Multiple Sclerosis
• Other Study ID Numbers: AEŞH-EK-2025-143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No