The Efficacy and Safety of Transcranial Temporal Interference Stimulation (tTIS) Targeting the Right Globus Pallidus Internus (GPi) for Motor Symptoms in Patients With PD
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
研究概览
简要总结
To demonstrate that intervention targeting the right globus pallidus internus (GPi) using transcranial temporal interference stimulation can improve motor symptoms in patients with Parkinson's disease.
详细描述
Each of patients received either 30-minute or sham tTIS of the right GPi. Before and immediately after the stimulation, participants completed the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III) in the "medication-on" state to assess the motor symptoms. MDS-UPDRS, HAMA and HAMD were assessed on intervention Day 1, Day 10 and 1-month follow-up and clinical efficacy was evaluated by comparing the scale scores before and after the intervention.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting the diagnostic criteria for Parkinson's disease in China (2016 version), diagnosed as PD by two neurologists;
- •Hoehn-Yahr stage 1.5-4;
- •Age > 50 years old;
- •No signs of moderate to severe depression: Beck Depression Inventory-II (BDI-II) score < 20;
- •No signs of dementia: Mini-Mental State Examination (MMSE) score > 21;
- •No change in medication regimen in the four weeks prior to enrollment;
- •Right-handed.
排除标准
- •History of other neuropsychiatric disorders;
- •History of alcohol or drug abuse;
- •Previous history of TMS or traditional TES treatment;
- •Presence of non-MRI compatible metal implants in the body, such as deep brain stimulation devices, pacemakers or stents.
研究组 & 干预措施
real stimulation
Participants will receive active tTIS for 10 days.
干预措施: Transcranial temporal interference stimulation (tTIS) (Device)
sham stimulation
Participants will receive sham tTIS for 10 days.
干预措施: Sham transcranial temporal interference stimulation (tTIS) (Device)
结局指标
主要结局
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
时间窗: On intervention Day 1, Day 10 and 1-month follow-up.
To assess the motor symptoms, participants completed the official Chinese version of MDS-UPDRS.The MDS-UPDRS-III includes 33 items, with scores ranging from 0 to 132. The subscores of MDS-UPDRS-III, including (1) rigidity (item 3.3), (2) bradykinesia (items 3.2, 3.4, 3.8, and 3.14), (3) tremor (items 3.15-3.18), and (4) axial signs (items 3.9-3.13), were also used as the secondary outcomes in the following analyses.
次要结局
- emotional symptoms assessed by the HAMA(on intervention Day 1, Day 10 and 1-month follow-up)
- emotional symptoms assessed by the HAMD(On intervention Day 1, Day 10 and 1-month follow-up.)
研究者
Yanghua Tian
Vice President of Anhui Medical University
The Second Hospital of Anhui Medical University