NCT07451600

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
6mo left

Started Mar 2026

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress30%
Mar 2026Nov 2026

First Submitted

Initial submission to the registry

February 17, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

March 25, 2026

Status Verified

February 1, 2026

Enrollment Period

8 months

First QC Date

February 17, 2026

Last Update Submit

March 23, 2026

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisTMSSpasticityBalance

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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 gastrocnemiu

    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

Secondary Outcomes (5)

  • Visual Analogue Scale (VAS)

    patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month

  • Expanded Disability Status Scale (EDSS)

    patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month

  • Functional Independence Measure (FIM)

    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)

    patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month

  • Six Minute Walk Test

    patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month

Study Arms (2)

rTMS M1

ACTIVE COMPARATOR

rTMS application on M1 cortex

Device: rTMS

sham rTMS

PLACEBO COMPARATOR

sham rTMS application on M1 cortex

Device: sham rTMS

Interventions

rTMSDEVICE

Low frequency rTMS application on M1 cortex

rTMS M1
sham rTMSDEVICE

Low frequency sham rTMS

sham rTMS

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06010, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 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: 36131925BACKGROUND

  • 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.

    PMID: 27481208BACKGROUND

  • 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: 31591833BACKGROUND

MeSH Terms

Conditions

Multiple SclerosisMuscle Spasticity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Özgür Zeliha Karaahmet, professor

    Ankara Etlik City Hospital

    STUDY DIRECTOR

Central Study Contacts

Melike Çil, specialist

CONTACT

+90 0312 797 00 00melike9671@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PM&R Specialist

Study Record Dates

First Submitted

February 17, 2026

First Posted

March 5, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

March 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)