Mechanism of Temporal Interference Stimulation on Brain Networks and Its Long-term Clinical Efficacy in 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
- 75
- 试验地点
- 1
- 主要终点
- Change from Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) total score.
研究概览
简要总结
Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor dysfunction. While deep brain stimulation (DBS) is effective, its invasive nature limits its application in early-stage patients. Temporal interference stimulation (TIS) is a novel non-invasive technique that can target deep brain structures like the globus pallidus internus (GPi) by using high-frequency electric fields.
This study aims to evaluate the clinical value and underlying mechanisms of TIS in PD patients. The research is divided into two phases: Phase A investigates the immediate regulatory effects of 130 Hz and 40 Hz TIS on brain networks using concurrent fMRI-TIS. Phase B is a randomized, double-blind, sham-controlled trial to assess the long-term efficacy and safety of a 2-week TIS intervention on both motor and non-motor symptoms. The results will help clarify how TIS modulates deep brain networks and its potential as a non-invasive therapy for PD.
详细描述
This study employs a two-phase design to systematically investigate the effects of Temporal Interference Stimulation (TIS) on Parkinson's Disease (PD).
Phase A: Acute fMRI Mechanism Study (n=15) In this crossover study, participants will undergo concurrent fMRI-TIS sessions. Two frequency envelopes will be tested: 130 Hz (to mimic DBS inhibitory effects) and 40 Hz (for gamma entrainment). The fMRI protocol follows an 8-20-8 minute design: 8 minutes of baseline, 20 minutes of concurrent stimulation, and 8 minutes of post-stimulation scan . Individualized electric field modeling based on high-resolution 3D-T1 MRI will be used to target the right GPi. Acute motor changes will be assessed using the MDS-UPDRS-III scale.
Phase B: Long-term Efficacy RCT (n=60) Participants will be randomly assigned to one of three parallel groups: 130 Hz TIS, 40 Hz TIS, or Sham stimulation. The intervention consists of 30-minute daily sessions for 2 weeks (10 sessions total).
Active Groups: TIS targeting the right GPi with individualized electrode configurations.
Sham Group: 20-second ramp-up and ramp-down to mimic skin sensation without continuous stimulation.
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)
盲法说明
Sham stimulation is used for blinding. It provides only a 20-second ramp-up and ramp-down of current to mimic the skin sensation of active stimulation.
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Parkinson's Disease according to the Movement Disorder Society (MDS) clinical diagnostic criteria.
- •Hoehn & Yahr Stage I-III (mild to moderate severity).
- •Aged 45 to 65 years.
- •Right-handed. Stable medication regimen for at least 1 hour before Phase A fMRI sessions and agreement to maintain a stable dosage during the 2-week Phase B intervention (unless clinically necessary).
- •Able to provide informed consent by the participant or a legal guardian.
排除标准
- •MRI contraindications, such as implanted DBS electrodes, cardiac pacemakers, or other metal implants.
- •Significant cognitive impairment (MoCA score < 24) or severe psychiatric symptoms.
- •History of epilepsy or structural brain lesions, including severe cerebral atrophy or cerebrovascular disease.
- •Severe head tremors that would interfere with MRI scanning quality.
研究组 & 干预措施
130 Hz TIS Group
Participants receive active Temporal Interference Stimulation (TIS) with a 130 Hz envelope frequency targeting the right globus pallidus internus (GPi).
干预措施: Temporal Interference Stimulation (130 Hz) (Device)
40 Hz TIS Group
Participants receive active TIS with a 40 Hz envelope frequency targeting the right GPi.
干预措施: Temporal Interference Stimulation (40 Hz) (Device)
Sham Group
Participants receive sham stimulation targeting the right GPi.
干预措施: Sham Temporal Interference Stimulation (Device)
结局指标
主要结局
Change from Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) total score.
时间窗: Baseline, 2 weeks (immediately after the 10th intervention session), and 1 month (follow-up).
The MDS-UPDRS Part III is a clinician-rated scale used to assess the motor signs of Parkinson's disease. It includes 18 items (33 scores total), with each item ranging from 0 (normal) to 4 (severe). The total score ranges from 0 to 132, where higher scores represent greater motor impairment.
次要结局
- Changes in Brain Network Functional Connectivity and Amplitude of Low-frequency Fluctuations (ALFF).(Baseline, 20 minutes (during concurrent TIS), and 8 minutes (immediately post-stimulation) for Phase A ; Baseline and 2 weeks for Phase B.)
研究者
Weiguo Liu
Professor, Chief Physician
Jiangsu Province Nanjing Brain Hospital