Effects of Combined Transcranial Electrical and Magnetic Stimulation of Cerebellum on Balance Function in Ataxia Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in the International Cooperative Ataxia Rating Scale (ICARS)
研究概览
简要总结
Ataxia refers to a group of neurological disorders characterized by impaired coordination and balance due to dysfunction in the cerebellum or its connections. Traditional therapeutic approaches for ataxia have shown limited efficacy, prompting researchers to explore alternative interventions. Non-invasive brain stimulation (NIBS) techniques, such as transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), and intermittent theta burst stimulation (iTBS), have emerged as potential therapeutic options. The aim of this study is to investigate the combined effect of tACS-iTBS on balance functions in ataxia disorders.
详细描述
Ataxia comprises a heterogeneous group of acquired or inherited disorders primarily involving cerebellar dysfunction, leading to impaired coordination and motor learning. Traditional treatments, including medication and physical therapy, often provide limited symptomatic improvement. Non-invasive brain stimulation (NIBS) techniques have emerged as promising tools for modulating cerebellar activity and enhancing motor function. Transcranial magnetic stimulation (TMS) can influence cortical excitability and plasticity, and studies have shown that high-frequency cerebellar rTMS can improve motor performance in spinocerebellar ataxia. Intermittent theta burst stimulation (iTBS), a patterned form of TMS, has demonstrated benefits in other movement disorders, suggesting potential applicability to ataxia. Transcranial direct current stimulation (tDCS), which modulates neuronal excitability via weak electrical currents, has shown improvements in static and dynamic balance in degenerative cerebellar ataxia. Transcranial alternating current stimulation (tACS) modulates neural oscillations and early studies indicate possible benefits for ataxia symptoms. Recent work has explored combining NIBS modalities to enhance neuromodulatory effects. In preliminary experiments, combined cerebellar tACS and iTBS increased MEP amplitudes more than iTBS alone, with effects lasting up to 30 minutes. These synergistic effects may translate into improved motor performance, coordination, and balance. The present study aims to investigate whether combining real or sham tACS with iTBS produces greater benefits than exergaming biofeedback alone in individuals with ataxia. A cross-over design will be used so that each participant serves as their own control. The primary outcomes will include motor coordination, balance, and cerebello-cortical plasticity. The rationale is that tACS may optimize oscillatory activity while iTBS enhances excitability, thereby jointly promoting neuroplasticity in cerebellar networks. The study will recruit individuals diagnosed with ataxia and assess the therapeutic potential of combined NIBS interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 80 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of ataxia based on clinical assessment and/or neuroimaging findings.
- •Stable medication regimen for at least four weeks prior to the study.
- •Sufficient cognitive ability to understand and comply with study instructions.
排除标准
- •History of seizures.
- •Severe general impairment or concomitant diseases.
- •Intracranial metal implants.
- •Cardiac pacemaker.
- •Pregnancy status.
研究组 & 干预措施
Real tACS + real iTBS + exergaming
10 sessions of real 5Hz tACS with real iTBS + exergaming biofeedback, 5 times per weeks for two weeks.
干预措施: Real (real iTBS/tACS + exergaming) (Device)
Sham tACS + sham iTBS + exergaming
10 sessions of sham 5Hz tACS with sham iTBS + exergaming biofeedback, 5 times per weeks for two weeks.
干预措施: Sham (sham iTBS/tACS + exergaming) (Device)
结局指标
主要结局
Changes in the International Cooperative Ataxia Rating Scale (ICARS)
时间窗: Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)
ICARS was developed to quantify the level of impairment as a result of ataxia as related to hereditary ataxias. Score ranges from 0 to 100 where 100 indicates severe ataxia.
次要结局
- Changes in the Short Form-36 Health Survey (SF-36)(Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2))
- Changes in postural control(Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2))
- Changes in cortico-spinal excitability(Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2))
- Change in the Scale for the Assessment and Rating of Ataxia (SARA)(Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2))
