Effect of Cerebellar High-Frequency rTMS in Improving Balance Performance in Multiple Sclerosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Expanded Disability Status Scale (EDSS)
研究概览
简要总结
Background: Multiple Sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system (CNS), leading to progressive motor dysfunction and balance deficits. Objective: To investigate the impact of cerebellar rTMS in improving postural control, balance performance and functional ambulation in individuals with MS.
Forty patients were randomly assigned to receive repetitive transcranial magnetic stimulation (rTMS) over the cerebellum to improve motor function and balance in 40 MS patients. Outcome measures, including the Expanded Disability Status Scale (EDSS), static posturography (COP measures), the International Cooperative Ataxia Rating Scale (ICARS), and the 10-Meter Walk Test (10MWT), were assessed before and after intervention.
详细描述
Background: Multiple Sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system (CNS), leading to progressive motor dysfunction and balance deficits. Although disease-modifying therapies have advanced, there remains an unmet need for effective treatments that target motor and cognitive impairments. Objective: To investigate the impact of cerebellar rTMS in improving postural control, balance performance, and functional ambulation in individuals with MS. Method: This randomized, single-blinded, placebo-controlled clinical trial evaluated the efficacy of repetitive transcranial magnetic stimulation (rTMS) over the cerebellum in improving motor function and balance in 40 MS patients. Outcome measures, including the Expanded Disability Status Scale (EDSS), static posturography (COP measures), the International Cooperative Ataxia Rating Scale (ICARS), and the 10-Meter Walk Test (10MWT), were assessed before and after intervention.
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)
盲法说明
Participants are single-blinded to group assignment. Those in the active group receive real cerebellar rTMS, while the control group receives sham stimulation using an identical coil setup and sound, but without actual magnetic pulses. The treating clinician administering the rTMS is not blinded, but participants are unaware of their assignment to maintain blinding integrity.
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
- •Patient age ≥18 years.
- •Patients with MS, established by clinical, laboratory, MRI criteria and matched Mc Donald's criteria, McDonald et al,
- •Expanded Disability Status Scale (EDSS) scores between 2.5-5
- •Only patients in "remitting" phase were included.
- •Informed consent.
排除标准
- •Factors that prevent patient cooperation understanding that impede proper study participation.
- •Disabling medical history as severe or recent heart disease and or severe head trauma.
- •Cognitive impairment: <24 points by mini-mental scale. (Folstein MF et al., 1975).
- •Diabetic patients.
- •Patients with any other comorbidity that can affect balance, e.g, other neurological diseases that can affect posterior column function.
- •Contraindications for rTMS:
- •History of epilepsy.
- •Metal (implants) in skull/scalp/head or fragments from welding or metalwork.
- •Implanted device (as spinal cord stimulator, cardiac pacemaker, and cochlear implants).
研究组 & 干预措施
Arm 1: Active Comparator - Real rTMS
Arm Label: Real rTMS
Type: Active Comparator
Description:
Participants in this group receive real repetitive transcranial magnetic stimulation (rTMS) targeting the cerebellum. Stimulation is delivered using a figure-of-eight coil positioned over the vermis of the cerebellum, at a frequency of 10 Hz, work period 5s, number of trains 25, ITI is 25s. The total number of pulses is 1250 pulses per session.
干预措施: cerebellar rTMS (Device)
Arm 2: Sham Comparator - Sham rTMS
Arm Label: Sham rTMS Type: Sham Comparator
Description:
Participants in this group receive sham stimulation using the same rTMS device and setup as the active group. The coil is adjusted to mimic the sound and feel of stimulation without delivering an effective magnetic pulse to the brain. Participants are blinded to their assignment to preserve study integrity.
干预措施: cerebellar rTMS (Device)
结局指标
主要结局
Expanded Disability Status Scale (EDSS)
时间窗: 3 years
Expanded Disability Status Scale (EDSS): Overall disability in MS
Static posturography
时间窗: 3 years
Static Posturography: Balance assessment using COP measures under eyes-open (COP-O) and eyes-closed (COP-C) conditions.
International Cooperative Ataxia Rating Scale (ICARS)
时间窗: 3 years
International Cooperative Ataxia Rating Scale (ICARS): Quantifies ataxia severity.
次要结局
- 10-Meter Walk Test (10MWT)(3 years)