Effectiveness of TMS on Spasticity and Balance for Patients With MS

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAnkara Etlik City Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Poor general health (heart failure, COPD, etc.)

Presence of wound lesions on the skin

Presence of metal implants in the body

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • rTMS

    Device

    Low frequency rTMS application on M1 cortex

  • sham rTMS

    Device

    Low frequency sham rTMS

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: rTMS M1Active comparator 1 intervention
Group B: sham rTMSPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

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

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.

Time frame
patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month
3

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

Time frame
patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month
4

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.

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

Secondary outcomes

1

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.

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

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.

Time frame
patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month
3

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).

Time frame
patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month
4

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.