Effect of Repetitive Transcranial Magnetic Stimulation With Intensive Physical Therapy in Cerebellar Ataxia: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- International Cooperative Ataxia Rating Scale (ICARS)
研究概览
简要总结
The present study investigated the efficacy and safety of combination treatment of repetitive transcranial magnetic stimulation (rTMS) and physical therapy (PT) in patients with cerebellar variant of multiple system atrophy (MSA-C) and spinocerebellar ataxia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients with probable MSA-C and spinocerebellar ataxia (SCA)
- •cerebellar ataxia as main clinical presenting feature and able to walk independently without walking devices
- •aged over 20
- •presence of cerebellar atrophy proven by brain MRI.
排除标准
- •secondary cerebellar ataxia
- •peripheral neuropathy, radiculopathy, or decreased visual acuity that can cause peripheral ataxia
- •musculoskeletal disease affecting gait or balance
- •other neurologic symptoms, including symptomatic parkinsonism (two or more rigidity and/or bradykinesia scores in one limb by Unified Parkinson's disease Rating Scale part 3) or spasticity (20)
- •psychiatric symptoms requiring medication or with cognitive decline (Mini-mental state examination [MMSE] < 20)
- •taking any sedative medications or anti-parkinsonian medications such as benzodiazepine, levodopa or dopamine agonist
- •history of seizure or metallic brain implants; (8) cardiopulmonary diseases causing dyspnea during exercise.
研究组 & 干预措施
Cerebellar rTMS + Physical therapy
rTMS was delivered on the scalp for over 2 cm under the inion, which is the scalp over the cerebellum area, using a double-cone coil connected to a Magstim Rapid2® stimulator with two Booster Modules (Magstim, Spring Gardens, Wales, UK) in accordance with safety recommendations. Stimulation was delivered to the cerebellum at 10 Hz with 90% of the mean resting motor threshold intensity for 5 seconds at 55 second intervals to deliver 1000 pulses in 20 minutes. Immediately after rTMS, the combination treatment group received balance and gait training by a physical therapist for 30 minutes/day and underwent aerobic exercise using a stationary bicycle at moderate intensity (12 to 14 rating of perceived exertion) for 30 minutes/day and 5 days/week for two weeks. In the control group, no participants received physical therapy or rTMS for two weeks.
干预措施: Cerebellar repetitive transcranial magnetic stimulation (Device)
Sham stimulation + Physical therapy
Sham stimulation was delivered on the scalp for over 2 cm under the inion, which is the scalp over the cerebellum area, using a double-cone coil connected to a Magstim Rapid2® stimulator. Sham stimulation was delivered to the cerebellum for 5 seconds at 55 second intervals in 20 minutes. Immediately after rTMS, the combination treatment group received balance and gait training by a physical therapist for 30 minutes/day and underwent aerobic exercise using a stationary bicycle at moderate intensity (12 to 14 rating of perceived exertion) for 30 minutes/day and 5 days/week for two weeks. In the control group, no participants received physical therapy or rTMS for two weeks.
干预措施: Cerebellar repetitive transcranial magnetic stimulation (Device)
结局指标
主要结局
International Cooperative Ataxia Rating Scale (ICARS)
时间窗: The change of ICARS score between baseline (T0) and immediately after (T1) treatment
The scale is scored out of 100 with 19 items and 4 subscales of postural and gait disturbances, limb ataxia, dysarthria, and oculomotor disorders. Higher scores indicate higher levels of impairment.
次要结局
- Change from Mini-Mental State Examination (MMSE)(The clinical scales were evaluated by blinded raters at baseline (T0) and immediately after (T1), 4 weeks after (T2), and 12 weeks (T3) after intervention.)
- Change from Beck depression inventory (BDI)(The clinical scales were evaluated by blinded raters at baseline (T0) and immediately after (T1), 4 weeks after (T2), and 12 weeks (T3) after intervention.)
- Change from temporospatial parameters of gait(The clinical scales were evaluated by blinded raters at baseline (T0) and immediately after (T1), 4 weeks after (T2), and 12 weeks (T3) after intervention.)
- Change from Barthel Index for Activities of Daily Living(The clinical scales were evaluated by blinded raters at baseline (T0) and immediately after (T1), 4 weeks after (T2), and 12 weeks (T3) after intervention.)
- Change from posturography(The clinical scales were evaluated by blinded raters at baseline (T0) and immediately after (T1), 4 weeks after (T2), and 12 weeks (T3) after intervention.)
- Change from International Cooperative Ataxia Rating Scale (ICARS)(The clinical scales were evaluated by blinded raters at baseline (T0) and 4 weeks after (T2), and 12 weeks (T3) after intervention.)
研究者
Jinyoung Youn
Associate Professor
Samsung Medical Center