Effect of Cerebellar Repetitive Transcranial Magnetic Stimulation on Coordination in Patients with Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Biodex balance system
研究概览
简要总结
To determine the efficacy of high frequency cerebellar repetitive transcranial magnetic stimulation on coordination in patients with multiple sclerosis.
详细描述
Forty patients with multiple sclerosis suffering from ataxia less than five in EDSS score will be recruited from the outpatient clinic at Faculty of Physical Therapy as well as Kasr Al-Ainy Multiple Sclerosis unit (KAMSU), Cairo University. The study will be applied during the remission period. Patients will be assessed by Biodex balance system, Berg balance scale, Four square step test and Nine-Hole Peg Test to investigate coordination in both equilibrium and non-equilibrium. Patient will be divided into two groups.The study group will be treated by High frequecy cerebellar repetitive transcranial magnetic stimulation besides a tailored physiotherapy program, while the control group will be treated by Sham cerebellar repetitive transcranial magnetic stimulation with a tailored physiotherapy program as well. The treatment duration for each patient will take weeks.
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
- Double (Participant, Care Provider)
盲法说明
Participant masking as patients will be divided into two groups High frequecy cerebellar repetitive transcranial magnetic stimulation and Sham repetitive transcranial magnetic stimulation by placing the coil in perpendicular way away from the cerebellum.
Care provider masking as the physical therapist treating patients will be blind from the application of repetitive transcranial magnetic stimulation
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically definite MS (relapsing, remitting and secondary progressive) patients
- •Patients who are medically stable and Free from relapses three months before
- •Ambulant patients without an assistive device and score less than 5 on the Kurtzke Expanded Disability Status Scale (EDSS)
- •Patients receiving their disease modifying drugs but no medication changing during the previous three months.
- •Patients who had MRI evidence of lesions in the cerebellum or in the cerebellar pedunculi.
- •Right handed patients.
- •Severity of ataxia range from 4 to 10 according to scale of assessment and rating ataxia (SARA).
- •Did not apply cerebellar transcranial magnetic stimulation before.
排除标准
- •Any other neurological deficits or orthopedics abnormalities.
- •Ataxic manifestations for other cause rather than Multiple Sclerosis.
- •Other neurological manifestations (e.g. spasticity, visual loss)
- •Secondary musculoskeletal complication such as contractures or deformities. Cardiovascular, pulmonary, hepatic, renal, hemopoietic and thyroid diseases.
- •Pregnant women.
- •Addicted individuals.
- •Previous surgeries in the brain.
- •Any magnetic or metallic devices implanted (like cochlear implants) .
- •Psychotic deficits or history of epileptic seizures.
研究组 & 干预措施
High frequency cerebellar repetitive transcranial magnetic stimulation
Twenty patients will be treated by high frequency repetitive transcranial magnetic stimulation (Hf-rTMS) targeting the cerebellum beside a tailored physical therapy program designed for the ataxic manifestation The protocol of rTMS included 6 sessions over 2 weeks. MagPro R20 device will be applied over midline of cerebellum using circular coil. Ten repetition rate in 40 trains with one inter train interval will be applied two times within the same session, 5 minutes rest in between Tailored physiotherapy program for ataxic manifestation will be applied for 10 days in the same 2 weeks
干预措施: High frequency repetitive transcranial magnetic stimulation (Device)
Sham cerebellar repetitive transcranial magnetic stimulation
Twenty patients will be treated by sham cerebellar rTMS with the same parameters, same duration 6 sessions over 2 weeks except the coil will not be on the middle of the cerebellum instead it will be perpendicular away from it.
But the program of physiotherapy is the same
干预措施: Sham repetitive transcranial magnetic stimulation (Device)
结局指标
主要结局
Biodex balance system
时间窗: 2 weeks after end of treatment
Change of balance and stability index from baseline to 2 weeks after the beginning of intervention (when the score decreases, this means good)
次要结局
- Berg balance scale(2 weeks after end of treatment)
- Nine-Hole Peg Test (9-HPT)(2 weeks after end of treatment)
- Four square step test (FSST)(2 weeks after end of treatment)
研究者
Hoda Zayed Abd Elraheem Mohamed
Assistant lecturer
Cairo University