Effects and Mechanisms of Non-invasive Deep Brain Stimulation in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score
研究概览
简要总结
The goal of this clinical trial is to learn whether a type of brain stimulation called transcranial temporal interference stimulation (TIS) of the internal globus pallidus (GPi) can help improve movement symptoms in people with Parkinson's disease. The study will also look at how TIS changes brain activity related to these improvements.
The main questions this study aims to answer are:
- How much can repeated TIS sessions improve movement symptoms in people with Parkinson's disease?
- Can these improvements last for up to two months after the treatment ends?
- What changes in brain activity happen along with the improvements?
Researchers will compare people who receive active TIS with those who receive sham (placebo-like) stimulation to see whether active TIS leads to better movement outcomes.
Participants will:
- Receive 10 sessions of active or sham TIS over two weeks
- Complete movement assessments during the two-week treatment and again 2, 4, and 8 weeks afterward
- Complete brain activity assessments before and after the two-week treatment
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A physician-diagnosed idiopathic Parkinson's disease (PD) according to the Movement Disorder Society (MDS) diagnostic criteria, with onset after the age of
- •Stable antiparkinsonian medication regimen, including levodopa-containing therapy, unchanged for at least 4 weeks before and during the trial.
- •Hoehn and Yahr (H&Y) stages 1.5 to 3 and ability to walk unassisted.
- •Absence of dementia, defined as a Montreal Cognitive Assessment (MoCA) score ≥ 21.
排除标准
- •Any contraindication for MRI or transcranial temporal interference stimulation (TIS), including claustrophobia, metallic implants in the head or heart, or a history of electroconvulsive therapy.
- •Current use of antipsychotic, antidepressant, or other dopamine-modulating medications.
- •Presence of orthopedic conditions that may interfere with motor assessments, such as osteoarthritis or recent orthopedic surgery (within the past 6 months).
- •History of physician-diagnosed major psychiatric illness.
- •Physician-diagnosed cardiovascular risks that could contraindicate exercise or study participation.
- •Prior history of deep brain stimulation (DBS) surgery.
研究组 & 干预措施
TIS Group
Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a two-week intervention period.
干预措施: Transcranial Temporal Interference Stimulation (TIS) (Device)
Sham Group
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period, without therapeutic stimulation.
干预措施: Transcranial Temporal Interference Stimulation (TIS) (Device)
结局指标
主要结局
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score
时间窗: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change in motor symptoms assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III). The total score ranges from 0 to 132, with higher scores indicating more severe motor impairment (worse outcome).
Participants With a ≥5-point Reduction From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score
时间窗: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
A responder was defined as a participant with a reduction of at least 5 points from baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III) total score. Scores range from 0 to 132, with higher scores indicating more severe motor impairment; therefore, a reduction in score indicates improvement.
the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score
时间窗: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change in motor symptoms assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III). The total score ranges from 0 to 132, with higher scores indicating more severe motor impairment (worse outcome).
次要结局
- Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-I (MDS-UPDRS I) Score(Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.)
- Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-II (MDS-UPDRS II) Score(Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.)
- Change From Baseline in the Epworth Sleepiness Scale Score(Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.)
- Change From Baseline in the Parkinson's Disease Sleep Scale-2 Score(Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.)
- Change From Baseline in the Gait Performance Measures(Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.)
- Change From Baseline in the Balance Performance Measures(Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.)
- Change From Baseline in the Magnetic Resonance Imaging (MRI) Measures(Baseline and immediately after the intervention)
- Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-bradykinesia Subscore(Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.)
- Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-rigidity Subscore(Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.)
- Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-axial Subscore(Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.)
- Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-tremor Subscore(Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.)
- Home Diary Assessment of Motor States(Baseline, immediately after 1 and 2 weeks of intervention)
- Parkinson's Disease Questionnaire-39 (PDQ-39) Score(Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.)
- the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-I (MDS-UPDRS I) Score(Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.)
- the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-II (MDS-UPDRS II) Score(Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.)
- Epworth Sleepiness Scale Score(Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.)
- Parkinson's Disease Sleep Scale-2 Score(Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.)
- Gait Performance Measures(Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.)
- Balance Performance Measures(Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.)
- Magnetic Resonance Imaging (MRI) Measures(Baseline and immediately after the intervention)
研究者
Yu Liu
Shanghai University of Sport
Shanghai University of Sport