Effectiveness of TMS on Spasticity and Balance for Patients With MS

Condition(s) studied

Investigational drug(s) / intervention(s)

rTMS: Low frequency rTMS application on M1 cortex

sham rTMS: Low frequency sham rTMS

Study 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.

Eligibility

Primary outcome measure(s)

• Modified Ashworth Scale — 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 — 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 — 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 — 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 — 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

Trial sites (1)

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