NCT06898645尚未招募不适用
Clinical Study on the Effecacy of Transcranial Magnetic Stimulation of Intermittent Theta Pulse Stimulation(iTBS) Navigated Targeting the Cerebellum in the Treatment of Hereditary Spinocerebellar Ataxia
Xijing Hospital0 个研究点目标入组 80 人开始时间: 2025年3月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- The change from baseline score on ICARS(International Cooperative Ataxia Rating Scale)
研究概览
简要总结
Spinocerebellar ataxia (SCA) is a type of autosomal dominant ataxia and there is currently no effective treatment. The goal of this clinical trial is to learn the efficacy of navigated iTBS (Intermittent theta-burst stimulation) targeting the cerebellum to treat hereditary spinocerebellar ataxias in adults and explore the role and neural plasticity mechanisms. It will also learn about the safety of cerebellar transcranial magnetic stimulation. The main questions it aims to answer are:
- Does navigated iTBS targeting the cerebellum improve the symptoms and clinical scale score of ataxias?
- Safety evaluation measures included treatment-related dizziness, head and neck pain, tinnitus, hearing loss, and epilepsy. Adverse reactions were reported by both subjects and investigators.
Participants will:
- Navigated iTBS targeting the cerebellum or sham stimulation every day for 7 day,
- Assessments were made at baseline, within 24 hours after the end of treatment, after 12 weeks, and after 24 weeks of telephone follow-up.
详细描述
- Gait analysis, electroencephalogram (EEG), functional magnetic resonance (fMRI) and a series of clinic scales were used to further observe the therapeutic effect and reveal the possible mechanism of neuroplasticity.
- Forty-two iTBS sessions（1,800 pulses per session, 50-minute intersession interval） were delivered as 6 daily sessions over 7 consecutive days at 80% resting motor threshold (adjusted for cortical depth).
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SCA1/2/3 patients confirmed by genetic testing
- •aged 18-65 years
- •presence of ataxia with a score3-20 on the Scale for the Assessment and Rating of Ataxia (SARA) and a score<60 on the International Cooperative Ataxia Rating Scale (ICARS)
- •Signed informed consent by patients or their family members
排除标准
- •Patients with serious medical conditions (such as kidney failure, liver disease) and uncontrolled high blood pressure or diabetes
- •Patients with severe cognitive and behavioral disorders or mental illness
- •Pregnant and lactating patients; Use other ongoing clinical medications, except for neuroprotective agents such as coenzyme Q10, butylphthalein, or cyticholine; If patients are taking valproate, riluzole and other drugs but they and their guardians have a strong desire for treatment, they can be evaluated again after washout.
- •History of stroke, encephalitis and epilepsy
- •Pacemakers, electronic devices and intracranial metal objects.
结局指标
主要结局
The change from baseline score on ICARS(International Cooperative Ataxia Rating Scale)
时间窗: at baseline, within 24 hours after the end of treatment, after 12 weeks, and within 24 hours after the end of the second round of treatment
International Cooperative Ataxia Rating Scale contains four subscales on a scale of 0 to 100, with higher scores indicating more severe ataxia
次要结局
- The change from baseline score on SARA(Scale for the Assessment and Rating of Ataxia)(at baseline, within 24 hours after the end of treatment, after 12 weeks, and within 24 hours after the end of the second round of treatment)
- Gait analysis(at baseline, within 24 hours after the end of treatment, after 12 weeks, and within 24 hours after the end of the second round of treatment)
- scalp electroencephalogram(at baseline, within 24 hours after the end of treatment, after 12 weeks, and within 24 hours after the end of the second round of treatment)
- Safety evaluation measures(within 24 hours after the end of treatment)
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