Remotely Supervised Home-based Transcranial Temporal Interference Stimulation on Motor Symptoms in Parkinson's Disease: Protocol For a Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III)
研究概览
简要总结
The goal of this clinical trial is to learn if home-based temporal interference stimulation (TIS) works to improve motor symptoms in people with Parkinson's disease (PD). It will also learn about the safety of this treatment. The main questions it aims to answer are:
- Does home-based TIS improve movement problems such as slow movement, stiffness, and walking difficulty?
- Are the effects maintained after the treatment ends?
- What medical problems (adverse events) occur during treatment? Researchers will compare active TIS to a sham treatment (a look-alike procedure that does not deliver active stimulation) to see if TIS works.
Participants will:
- Receive active TIS or sham stimulation once a day for 4 weeks at home under remote supervision
- Visit the clinic at specific time points for movement assessments
- Complete online questionnaires about symptoms and quality of life
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's disease according to established clinical criteria
- •Mild-to-moderate disease severity, defined as Hoehn and Yahr stage 1.5-3;
- •Age between 40 and 80 years;
- •Stable anti-parkinsonian medication regimen;
- •Ability to walk unaided for at least 2 minutes.
排除标准
- •contraindications to TIs (e.g., metal implantation, pacemakers, etc.);
- •the use of DBS;
- •significant cognitive impairment as defined by the diagnosis of Alzheimer's disease or dementia, or Montreal Cognitive Assessment (MoCA) total score<21, a recommended threshold for dementia in PD;
- •diagnosis of other neurological conditions such as multiple sclerosis, previous stroke;
- •report of severe lower-extremity arthritis, pain, or orthopedic problems significantly affecting gait;
- •physician-diagnosis of schizophrenia or other psychiatric illness;
- •an unwillingness to cooperate or participate in the study protocol. Eligible and interested participants will then be enrolled and complete baseline assessments before the randomization.
研究组 & 干预措施
Sham-TIs Group
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. The sham procedure consists of 28 sessions delivered over a four-week period, without therapeutic stimulation.
干预措施: Home-based Transcranial Temporal Interference Stimulation (HB-TIS) (Device)
TIs-Group
Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a four-week intervention period.
干预措施: Home-based Transcranial Temporal Interference Stimulation (HB-TIS) (Device)
结局指标
主要结局
Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III)
时间窗: Baseline, immediately after 1 and 4 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).
The time to complete 3-meter instrumented Timed Up and Go (iTUG) test
时间窗: Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention
Participants will wear six wearable sensors of Mobility Lab system (Clario, Philadelphia, PA) to measure the kinematic data when performing iTUG test. In each trial, participants will be asked to stand up from a chair, walk straightforward for 3 meters, make a 180-degree turn, walk back straightly to the chair and sit down.
次要结局
- The time to complete sit-to-stand and stand-to-sit transitions in 3m-iTUG(Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.)
- Turning time during 3m-iTUG(Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention)
- Response rate of MDS-UPDRS-III and gait speed(Baseline, immediately after 1 and 4 weeks of intervention)
- MDS-UPDRS-III sub scores(Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention)
- Geriatric Anxiety Inventory (GAI)(Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention)
- Geriatric Depression Scale (GDS)(Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention)
- Scales for Outcomes in Parkinson's Disease-Autonomic (SCOPA-AUT)(Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention)
- Montreal Cognitive Assessment (MOCA)(Baseline, after 4 weeks of intervention)
- Trail Making Test (Part A/B)(Baseline, after 4 weeks of intervention)
- The Digit Span Test evaluates (DST)(Baseline, after 4 weeks of intervention)
- Parkinson's Disease Sleep Scale-2 (PDSS-II)(Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention)
- Epworth Sleeping Scale (ESS)(Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention)
- Parkinson's Disease Questionnaire-39 (PDQ-39)(Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention)
- Home Diary Assessment of Motor States(Baseline, immediately after 1, 2, 3, 4 weeks of intervention)
- Safety related outcomes(After each intervention session (28 sessions over 4 weeks).)
研究者
Yu Liu
Prof
Shanghai University of Sport