Study of Multi-Modal Imaging Technology in MRI-Guided Transcranial Magnetic Stimulation Treatment for Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- MDS-UPDRS-III
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy of targeting the newly discovered SCAN versus traditional effector-specific networks in M1 using multimodal imaging and rTMS in patients with Parkinson's disease. The main question it aims to answer is: Is rTMS targeting the SCAN more effective than rTMS targeting effector networks?
详细描述
Parkinson's disease (PD) is a neurodegenerative disorder commonly affecting middle-aged and elderly individuals. Besides conventional treatments such as medication (e.g., levodopa) and surgery (e.g., deep brain stimulation), non-invasive neuromodulation techniques, such as transcranial magnetic stimulation (TMS), have been widely used as a safe and well-tolerated non-pharmacological adjunct therapy for PD patients. However, the limited efficacy of TMS may be attributed to an incomplete understanding of PD-related cortical circuits and imprecise targeting.
Historically, the primary motor cortex (M1) has been selected as the repetitive TMS (rTMS) target for PD treatment. In 2022, Gordon et al. discovered a new network within the M1 that differs from effector-specific networks responsible for executing movements of specific body parts, such as those for the foot, hand, and face. This newly identified network, named the somato-cognitive action network (SCAN), is located in inter-effector regions and is responsible for motor planning, control, and coordination. Damage to this network correlates with key PD symptoms, making SCAN a promising new target for PD intervention.
This study aims to compare the efficacy of targeting the newly discovered SCAN versus traditional effector-specific networks in M1 using multimodal imaging and Intermittent theta burst stimulation (iTBS), a rapid form of rTMS. The objective is to provide new clinical evidence for non-invasive neuromodulation in Parkinson's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, 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
- •Diagnosis of primary PD per the MDS Clinical Diagnostic Criteria (2015) or the Chinese Parkinson's Disease Diagnostic Criteria (2016).
- •Stable use of anti-PD medication for at least two months prior to enrollment.
- •Normal cognitive function (MMSE > 24).
- •Understanding of the study and signing of informed consent.
排除标准
- •Diagnosed with other neurological diseases, such as stroke, brain tumor, traumatic brain injury, motor neuron disease, Alzheimer's disease, multiple sclerosis, etc.
- •Implanted medical devices incompatible with MRI, such as deep brain stimulators, pacemakers, cochlear implants, or vagus nerve stimulators.
- •Conditions contraindicated for MRI, such as claustrophobia, tattoos, or magnetic metal implants.
- •Personal or family history of epilepsy.
- •Prior neuromodulation treatments (e.g., TMS, transcranial electrical stimulation, transcranial ultrasound stimulation) within the last three months.
- •Other health abnormalities that the investigator deems unsuitable for study participation.
结局指标
主要结局
MDS-UPDRS-III
时间窗: Baseline, 7 days, 14 days
The primary outcome is the difference in MDS-UPDRS-III scores at the "on" state at day 7 and day 14 after iTBS intervention.
次要结局
未报告次要终点