Study on the Efficacy of Temporal Interference Stimulation (TIS) for Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 主要终点
- UPDRS-3
研究概览
简要总结
The primary objective of this clinical study is to evaluate the therapeutic efficacy of Temporal Interference Stimulation (TIS), a non-invasive deep brain stimulation technique, in patients with Parkinson's disease, and to further investigate its potential mechanisms of action. Although TIS offers lower stimulation intensity and precision compared to conventional Deep Brain Stimulation (DBS), it possesses the distinct advantage of being non-invasive. This study utilizes TIS to explore different stimulation targets analogous to those used in DBS for Parkinson's disease, thereby providing valuable insights for subsequent DBS surgical interventions. The findings will contribute preliminary exploratory evidence regarding the application of non-invasive deep brain stimulation technology in the treatment of Parkinson's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males or females aged 40 years or above;
- •Diagnosed with idiopathic Parkinson's disease according to the UK Brain Bank Criteria, with onset after 40 years of age;
- •Previous or current dopaminergic replacement therapy (e.g., levodopa) with good response; (4) Hoehn and Yahr (H&Y) stage 1.5-2.5;
- •Ability to walk independently without assistive devices for at least 5 minutes;
- •Absence of severe freezing of gait (FOG);
- •Disease duration ≥2 years since diagnosis, with stable clinical condition and ability to comply with study assessments and interventions;
- •Stable medication dosage for at least 4 weeks prior to the study;
- •Hoehn and Yahr (H&Y) stage 1.5-2.5;
- •Signed informed consent, with the participant or legal guardian capable of understanding and willing to participate in the study.
排除标准
- •Presence of other neurological disorders that may interfere with the study
- •Mild or greater cognitive impairment (MoCA score ≤23)
- •Orthopedic or other health conditions that may affect gait or balance
- •Contraindications to MRI scanning, such as claustrophobia
- •History of antipsychotic, antidepressant, or other medications that may affect dopamine levels
- •Other significant psychiatric history
- •Contraindications including history of epilepsy, traumatic brain injury, or implanted metal devices in the brain or heart (e.g., stimulators, pacemakers)
- •History of electroconvulsive therapy
- •Concurrent participation in other gait- or balance-related intervention training
- •Physician-diagnosed cardiovascular risk factors for exercise.
结局指标
主要结局
UPDRS-3
时间窗: From enrollment through the 3-month follow-up
Changes in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III) scores from baseline to immediately after and 1 month after a single treatment session.
次要结局
未报告次要终点
研究者
BinMei
Attending Physician
Zhongnan Hospital