Safety and Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Ambulatory Function in Patients With Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Differences of Timed Up and Go Test (TUG)
研究概览
简要总结
The objective of this study was to determine the effects of protocols of repetitive transcranial magnetic stimulation (rTMS) therapy based on the functional reserve of each patient with Parkinson's disease, compared to conventional high-frequency rTMS therapy on bilateral primary motor cortex (M1). Investigators hypothesized that the functional reserve of each patient with Parkinson's disease will be different, and therefore an appropriate simulating target for rTMS therapy is needed. In addition, this approach could be more effective compared to conventional protocols applied to patient with Parkinson's disease regardless of their severity, predicted mechanism of motor function recovery, or functional reserves.
详细描述
rTMS treatment for patients with Parkinson's disease is traditionally based on stimulating the neural network of brain. The widely-used traditional rTMS treatment protocol involves high-frequency stimulation over the bilateral primary motor cortex (M1) to enhance motor and gait functions. However, concerns have arisen regarding the effect of rTMS on motor recovery in patients with Parkinson's disease. Although still subject to debate, a possible reason for the diverse results of rTMS applied is the uniform application protocol to individuals with varying pathologies and functional reserves, aimed at enhancing recovery.
Therefore, this study was aimed to determine the effects of protocols of rTMS therapy based on the functional reserve of each patient with Parkinson's disease.
Based on screening evaluations (Timed Up and Go Test (TUG), Timed Up and Go Dual Task-Cognitive (TUG-Cog)), investigators hypothesized that patients could be categorized into two groups: 1) priority in motor functional reserve, 2) priority in cognitive functional reserve. For each group, investigators plan to randomly assign patients to experimental and control groups to demonstrate the efficacy of different rTMS protocols based on functional reserves compared to conventional high-frequency rTMS applied to the bilateral M1.
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
The participants, assessors, and investigators will be blinded, not be aware of the group allocation. Statistical analysis will also be conducted by data analysts without awareness of the group allocation. Only clinicians applying rTMS intervention will not be blinded, as they will apply rTMS over different stimulation sites based on the protocols. Blinding will be continued until the end of the study, including data analysis.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with Parkinson's disease, diagnosed by the United Kingdom (UK) Parkinson's Disease Society Brain Bank Diagnostic Criteria,
- •Modified Hoehn and Yahr (H&Y) scale, stage 2~4,
- •patients who can walk on flat surfaces without the need for a gait aid,
- •aged ≥50 years old,
- •patients willing to sign the informed consent.
排除标准
- •those with contraindications to rTMS, such as epilepsy, implanted metal objects in the head, or a history of craniotomy,
- •those with cognitive impairment, confirmed through the Montreal Cognitive Assessment (MoCA) test as follows: < 7 points: Illiterate < 13 points: Education duration 0.5-3 years < 16 points: Education duration 4-6 years < 19 points: Education duration 7-9 years < 20 points: Education duration 10 years or more
- •those with coexisting neurological conditions, such as spinal cord injury or Stroke,
- •those with major psychiatric disorders, such as major depression, schizophrenia, or dementia,
- •those with severe on-off phenomena or severe dyskinesia, deemed by the investigators to render participation in the study inappropriate.
- •those having contraindications to conduct an MRI study,
- •those who are pregnant or lactating,
- •patients who have refused to participate in this study.
研究组 & 干预措施
Ipsilateral High-Frequency
Patients with motor priority confirmed by TUG and TUG-Cog tests.
High-frequency (HF) rTMS over more affected primary motor cortex (M1) of lower extremity will be applied.
干预措施: High-Frequency, ipsilateral M1 (Device)
Bilateral High-Frequency1
Patients with motor priority confirmed by TUG and TUG-Cog tests.
High-frequency (HF) rTMS over bilateral M1 of lower extremities will be applied.
干预措施: High-Frequency, bilateral M1 (Device)
DLPFC High-Frequency
Patients with cognitive priority confirmed by TUG and TUG-Cog tests.
High-frequency (HF) rTMS over Lt. dorsolateral prefrontal cortex (DLPFC) will be applied.
干预措施: High-Frequency, Lt. DLPFC (Device)
Bilateral High-Frequency2
Patients with cognitive priority confirmed by TUG and TUG-Cog tests.
High-frequency (HF) rTMS over bilateral M1 of lower extremities will be applied.
干预措施: High-Frequency, bilateral M1 (Device)
结局指标
主要结局
Differences of Timed Up and Go Test (TUG)
时间窗: From baseline T0 to Post-intervention T2 (4 weeks)
Measurement for gait function.
次要结局
- Differences of Timed Up and Go Test (TUG)(From baseline T0 to Follow-up T3 (2 months))
- Differences of Timed Up and Go Test-Cognitive (TUG-Cog)(From baseline T0 to Follow-up T3 (2 months))
- Differences of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III(From baseline T0 to Post-intervention T2 (4 weeks))
- Differences of MDS-UPDRS, Part III(From baseline T0 to Follow-up T3 (2 months))
- Differences of Gait lab parameter (Stride length)(From baseline T0 to Follow-up T3 (2 months))
- Differences of Gait lab parameter (Cadence)(From baseline T0 to Follow-up T3 (2 months))
- Differences of New Freezing of Gait Questionnaire (FoG-Q)(From baseline T0 to Follow-up T3 (2 months))
- Differences of Digit span Test(From baseline T0 to Follow-up T3 (2 months))
- Differences of Gait lab parameter (Gait speed)(From baseline T0 to Follow-up T3 (2 months))
- Differences of Gait lab parameter (Step count)(From baseline T0 to Follow-up T3 (2 months))
- Differences of Gait lab parameter (Swing ratio)(From baseline T0 to Follow-up T3 (2 months))
- Differences of Trail making Test(From baseline T0 to Follow-up T3 (2 months))
- Differences of Gait lab parameter (Stride time)(From baseline T0 to Follow-up T3 (2 months))
- Differences of Gait lab parameter (Pressure distribution)(From baseline T0 to Follow-up T3 (2 months))
- Differences of Timed Up and Go Test (TUG)(From baseline T0 to During-intervention T1 (2 weeks))
- Differences of Timed Up and Go Test-Cognitive (TUG-Cog)(From baseline T0 to During-intervention T1 (2 weeks))
- Differences of Timed Up and Go Test-Cognitive (TUG-Cog)(From baseline T0 to Post-intervention T2 (4 weeks))
- Differences of New Freezing of Gait Questionnaire (FoG-Q)(From baseline T0 to Post-intervention T2 (4 weeks))
- Differences of Digit span Test(From baseline T0 to Post-intervention T2 (4 weeks))
- Differences of Trail making Test(From baseline T0 to Post-intervention T2 (4 weeks))
- Differences of Gait lab parameter (Gait speed)(From baseline T0 to Post-intervention T2 (4 weeks))
- Differences of Gait lab parameter (Stride length)(From baseline T0 to Post-intervention T2 (4 weeks))
- Differences of Gait lab parameter (Step count)(From baseline T0 to Post-intervention T2 (4 weeks))
- Differences of Gait lab parameter (Cadence)(From baseline T0 to Post-intervention T2 (4 weeks))
- Differences of Gait lab parameter (Swing ratio)(From baseline T0 to Post-intervention T2 (4 weeks))
- Differences of Gait lab parameter (Stride time)(From baseline T0 to Post-intervention T2 (4 weeks))
- Differences of Gait lab parameter (Pressure distribution)(From baseline T0 to Post-intervention T2 (4 weeks))
研究者
Won Hyuk Chang
Professor
Samsung Medical Center