The Effect of Transcranial Magnetic Stimulation on Spasticity and Balance in Patients Diagnosed With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Modified Ashworth Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Modified Ashworth Scale
时间窗: 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
时间窗: 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
时间窗: 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 gastrocnemiu
BERG Balance Scale
时间窗: 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.
次要结局
- 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)
研究者
Ayse Naz Kalem
PM&R Specialist
Ankara Etlik City Hospital