Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, TMS, Spasticity, Balance
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.
Interventions
DEVICErTMS
Low frequency rTMS application on M1 cortex
DEVICEsham rTMS
Low frequency sham rTMS
Sponsors
Ankara Etlik City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) | patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month | 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. |
| Expanded Disability Status Scale (EDSS) | patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month | 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. |
| Functional Independence Measure (FIM) | patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month | 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). |
| 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 | 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. |
| Six Minute Walk Test | patients will be checked on first day of hospitalization, after treatment at 2 weeks and after treatment 1 month | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTMelike Çil, specialist
STUDY_DIRECTORÖzgür Zeliha Karaahmet, professor
Ankara Etlik City Hospital
Outcome results
None listed