Efficacy of MRI-Guided Transcranial Temporal Interference Electrical Stimulation (tTIS) Modulation for Parkinson's Disease: An Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 26
- 主要终点
- Change in Score on Part III (Motor Examination) of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
研究概览
简要总结
This study aims to evaluate the efficacy and safety of tTIS treatment in patients with Parkinson's disease (PD). The study will enroll eligible PD patients and randomly assign them to two groups: Group A will first receive combined GPi and STN stimulation, followed by GPi stimulation one week later; Group B will first receive GPi stimulation, followed by combined GPi and STN stimulation one week later. The MDS-UPDRS Part III will be assessed at pre-stimulation baseline, immediately after stimulation, and at 30 and 60 minutes post-stimulation for each session, in order to evaluate and compare the therapeutic effects of tTIS targeting GPi alone versus combined GPi and STN stimulation on motor symptoms in PD patients, and to assess the differential efficacy of tTIS at different targets among PD patients with varying symptoms.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years (inclusive), any gender.
- •Diagnosis of idiopathic Parkinson's disease according to the Chinese diagnostic criteria for Parkinson's disease (2016 edition).
- •Hoehn and Yahr stage 2-4 (inclusive) during the "off" state.
- •Documented response to levodopa (>33% improvement), with a stable anti-parkinsonian medication regimen for at least 4 weeks prior to screening, and no dose adjustments during the study.
- •Voluntary signed informed consent, and ability to understand and comply with the study protocol to complete the study.
- •No significant cognitive impairment (Montreal Cognitive Assessment [MoCA] score ≥21).
排除标准
- •Inability or unwillingness to comply with the study protocol and/or inability to provide written informed consent;
- •Presence of a significant medical condition that may interfere with study procedures or confound the assessment of study endpoints;
- •Presence of a severe psychiatric disorder that may affect the participant's ability to comply with the study protocol;
- •A history of psychiatric disorders or current severe depression or anxiety;
- •Presence of metallic implants in the brain;
- •Known pregnancy or current breastfeeding;
- •Severe neurological disorders, such as a brain tumor;
- •Severe cardiac disease, including the presence of an implanted cardiac pacemaker;
- •Scalp lesions, inflammation, infection, active bleeding, or an increased bleeding tendency;
- •Any other current medical condition for which the use of transcranial electrical stimulation may pose an unacceptable risk;
- •A history of epilepsy or structural brain lesions, including severe cerebral atrophy or cerebrovascular disease;
- •Inability to undergo magnetic resonance imaging (MRI), such as because of claustrophobia or implanted metallic devices;
- •Inability to cooperate with or complete the required assessments; or any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in the study.
研究组 & 干预措施
Experimental group A
Patients in this group receive individualized targeting based on MRI head modeling. During the medication-off period, they first undergo 130 Hz combined GPi and STN stimulation (GPi+STN), and one week later, they undergo 130 Hz GPi stimulation alone.
干预措施: Temporal Interference Stimulation (130 Hz) (Device)
Experimental group B
Patients in this group receive individualized targeting based on MRI head modeling. During the medication-off period, they first undergo 130 Hz GPi stimulation alone, and one week later, they undergo 130 Hz combined GPi and STN stimulation (GPi+STN).
干预措施: Temporal Interference Stimulation (130 Hz) (Device)
结局指标
主要结局
Change in Score on Part III (Motor Examination) of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
时间窗: at pre-stimulation baseline, immediately after stimulation, and at 30 and 60 minutes post-stimulation
The motor function of patients was assessed using Part III of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III), which has a total score range of 0 to 132. In this scale, a higher score indicates greater severity of motor symptoms and therefore a worse outcome, with 0 representing no impairment and 132 representing the most severe impairment. Changes in the score reflect the degree of improvement in motor function.
次要结局
未报告次要终点
研究者
Tang Zhouping
Principal Investigator
Tongji Hospital