Multiple SclerosisNCT07451600
Effectiveness of TMS on Spasticity and Balance for Patients With MS
A study testing rTMS in people with Multiple Sclerosis, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara, Yenimahalle, 06010
Melike Çil, specialist, +90 0312 797 0000, melike9671@gmail.com
About this study
Official title: 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.
- Conditions
- Multiple Sclerosis
- Being tested
- rTMS, sham rTMS
- Keywords
- Multiple Sclerosis, TMS, Spasticity, Balance
- Medical subject headings
- Multiple Sclerosis, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
Low frequency rTMS application on M1 cortex
sham rTMSDevice
Low frequency sham rTMS
| Study group | Role | What they receive |
|---|---|---|
| rTMS M1 | Active comparator | rTMS application on M1 cortex Receives: Device: rTMS |
| sham rTMS | Placebo comparator | sham rTMS application on M1 cortex Receives: Device: sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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 examination
- 1: Decrease of 2 units in the MAS score compared to the initial examination
- 2: Decrease of 3 units or more in the MAS score compared to the initial examination
Measured: patients will be checked on first day of hospitalization and after treatment 1 month
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Mar 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayse Naz Kalem, Ankara Etlik City Hospital
- Investigators
- Özgür Zeliha Karaahmet, professor, Study director, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451600
- Sponsor's protocol ID
- AEŞH-EK-2025-143
- Status last verified
- Mar 2026
- First submitted
- 17 Feb 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36131925Boutiere 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.
PubMed 27481208San 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.
PubMed 31591833
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcranial Magnetic Stimulation on Spasticity and Balance in Patients Diagnosed With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07451600
- Acronym / sponsor ID
- AEŞH-EK-2025-143
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, TMS, Spasticity, Balance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 5 Mar 2026 (actual)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS M1 | Active comparator | Device: rTMSrTMS application on M1 cortex |
| sham rTMS | Placebo comparator | Device: sham rTMSsham rTMS application on M1 cortex |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| rTMSLow frequency rTMS application on M1 cortex | Device | rTMS M1 |
| sham rTMSLow frequency sham rTMS | Device | sham rTMS |
Primary outcome
Modified Ashworth Scale
Time frame: patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month
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.
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
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.
Modified Tardieu Scale
Time frame: patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month
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
BERG Balance Scale
Time frame: patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month
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.
Goal Attainment Scale
Time frame: patients will be checked on first day of hospitalization and after treatment 1 month
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 examination * 1: Decrease of 2 units in the MAS score compared to the initial examination * 2: Decrease of 3 units or more in the MAS score compared to the initial examination
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Background: PubMed 36131925Zhou 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.
- Background: PubMed 27481208Boutiere 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.
- Background: PubMed 31591833San 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.
- Individual participant dataSharing planned: No
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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.
Özgür Zeliha Karaahmet, professor study director
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Multiple Sclerosis, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 3 Apr 2026. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melike Çil, specialist (+90 0312 797 00 00 ext. +903122911000, melike9671@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (time frame: patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07451600, which also lists 3 linked publications.
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 3 Apr 2026.