Effect of High Frequency Cerebellar Repetitive Transcranial Magnetic Stimulation on Functional Ambulation of Patients With Cerebral Small Vessel Disease
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
- Timed Up and Go Test
研究概览
简要总结
This study aims to evaluate the effect of repetitive transcranial magnetic stimulation (rTMS) applied over the cerebellum on gait performance and balance in patients with cerebral small vessel disease (CSVD). CSVD is associated with impaired mobility and increased risk of falls, which can significantly affect functional independence and quality of life.
Participants will be randomly assigned to receive either active cerebellar rTMS or sham stimulation over a defined treatment period. Gait and balance will be assessed using objective clinical measures, including the Timed Up and Go test (TUG) and the 10-Meter Walk Test (10MWT), at baseline, after the intervention, and during follow-up.
The study aims to determine whether active cerebellar rTMS leads to greater improvement in motor function and mobility compared to sham stimulation in patients with CSVD.
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 blinded to group assignment. Individuals in the active rTMS and sham groups will undergo similar procedures to ensure that participants are unaware of the type of stimulation received. Care providers and investigators administering the intervention are not blinded.
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients included aged 30 years or older.
- •Presenting with impaired gait DUE TO CSVD, Type I Arteriosclerosis-related CSVD (Hypertension, Diabetes). Or Type IV; Inflammatory/immunologically mediated CSVD: Systematic Vasculitis
排除标准
- •Moderate to severe cognitive impairment (excluded by mini mental state test)
- •Uncontrolled Diabetes mellites (HBA1C > 7%)
- •Recent head trauma.
- •Mental disorders.
- •Other co-existing neurological disease as Multiple sclerosis, ALS,..
- •Other causes of peripheral neuropathy (metabolic disorders, radiation induced, toxic, … etc)
- •Patients with acute stroke.
- •Any contraindications for rTMS as skull defects, epilepsy, brain implants, pacemaker or pregnancy.
- •Vasculitis secondary to CNS infections tuberculosis, syphilis, HIV, leptospirosis.
研究组 & 干预措施
Sham rTMS
Participants in this group will receive sham stimulation that mimics the procedure of rTMS without delivering active magnetic stimulation, applied over the cerebellum for the same duration and frequency as the active group.
干预措施: Sham Repetitive Transcranial Magnetic Stimulation (Device)
Active rTMS
Participants in this group will receive active repetitive transcranial magnetic stimulation (rTMS) applied over the cerebellum according to the study protocol 1250 pulses, 10 hz frequency over the treatment period of 6 weeks
干预措施: Repetitive Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
Timed Up and Go Test
时间窗: Baseline, 6 weeks, 10 weeks
Time (in seconds) required to stand, walk 3 meters, turn, and sit
次要结局
未报告次要终点
研究者
Noha Amr Eweis ElSayed
Principal Investigator
Ain Shams University