Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Upper Limb Function in Subacute Stroke Patients: A Multi Center, Randomized, Single Blind, Parallel Group Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL)
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 hemiplegic stroke patient in subacute phase, compared to conventional low-frequency rTMS therapy on contralateral M1. Investigators hypothesized that the functional reserve of each hemiplegic stroke patient 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 stroke patients regardless of their severity, predicted mechanism of motor function recovery, or functional reserves.
详细描述
rTMS treatment for patients with stroke is traditionally based on interhemispheric interactions. The widely-used traditional rTMS treatment protocol involves inhibitory low-frequency or continuous theta burst stimulation (cTBS) applied over the contralesional hemisphere and excitatory high-frequency stimulation over the ipsilesional hemisphere. However, concerns have arisen regarding the effect of rTMS on motor recovery in stroke patients. Although still subject to debate, a possible reason for the diverse results of rTMS applied to stroke patients 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 hemiplegic stroke patient.
Based on screening evaluations (TMS-induced motor evoked potential (MEP), diffusion tensor imaging (DTI), MRI), investigators hypothesized that patients could be categorized into three groups: 1) preserved ipsilateral corticospinal tract, 2) preserved ipsilateral alternative corticospinal tract, and 3) no ipsilateral corticospinal tract preserved. 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 inhibitory rTMS applied to the contralesional primary motor cortex.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hemiplegic stroke patients in the subacute phase (7 days to 3 months from the onset) who are currently hospitalized,
- •FMA score of the upper extremity ≤42,
- •adequate language and cognitive function to perform at least a 1-step obey-command,
- •pre-stroke functional level of modified Rankin Scale (mRS) ≤1,
- •aged ≥19 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 progressive of hemodynamically unstable medical conditions,
- •those with coexisting neurological conditions, such as spinal cord injury or Parkinson's disease,
- •those with major psychiatric disorders, such as major depression, schizophrenia, or dementia,
- •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
cTBS2
Absent responses in TMS-induced MEPs, but confirmed corticospinal tract integrity in DTI; Preserved ipsilateral alternative corticospinal tract.
continous Theta Burst Stimulation (cTBS) protocol of rTMS over contralateral primary motor cortex will be applied.
干预措施: cTBS2 (Device)
High-Frequency1
Confirmed responses in TMS-induced MEP: Preserved ipsilateral corticospinal tract.
High-frequency rTMS over ipsilateral primary motor cortex will be applied.
干预措施: High-Frequency1 (Device)
cTBS1
Confirmed responses in TMS-induced MEP: Preserved ipsilateral corticospinal tract.
continous Theta Burst Stimulation (cTBS) protocol of rTMS over contralateral primary motor cortex will be applied.
干预措施: cTBS1 (Device)
High-Frequency2
Absent responses in TMS-induced MEPs, but confirmed corticospinal tract integrity in DTI; Preserved ipsilateral alternative corticospinal tract.
High-frequency rTMS over ipsilateral premotor cortex will be applied.
干预措施: High-Frequency2 (Device)
High-Frequency3
Absent responses in all ipsilateral corticospinal tract.
High-frequency rTMS over contralateral primary motor cortex will be applied.
干预措施: High-Frequency3 (Device)
cTBS3
Absent responses in all ipsilateral corticospinal tract.
continous Theta Burst Stimulation (cTBS) protocol of rTMS over contralateral primary motor cortex will be applied.
干预措施: cTBS3 (Device)
结局指标
主要结局
Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL)
时间窗: From baseline T0 to Post-intervention T2 (2 weeks)
Measurement for motor function of upper limb. Minimum: 0, Maximum: 66. Higher score means a better
次要结局
- Differences of Fugl-Meyer Assessment score (FMA)(From baseline T0 to Follow-up T3 (2 months))
- Differences of Action Research Arm Test (ARAT)(From baseline T0 to Follow-up T3 (2 months))
- Differences of Jebsen-Taylor hand function test(From baseline T0 to Follow-up T3 (2 months))
- Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL)(From baseline T0 to Follow-up T3 (2 months))
- Differences of Hand grip strength test(From baseline T0 to Follow-up T3 (2 months))
- Differences of Box and block test(From baseline T0 to Follow-up T3 (2 months))
- Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL)(From baseline T0 to Follow-up T3 (2 months))
- Differences of Functional Ambulation Category (FAC)(From baseline T0 to Follow-up T3 (2 months))
- Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL)(From baseline T0 to During-intervention T1 (1 week))
- Differences of Fugl-Meyer Assessment score (FMA)(From baseline T0 to During-intervention T1 (1 week))
- Differences of Fugl-Meyer Assessment score (FMA)(From baseline T0 to Post-intervention T2 (2 weeks))
- Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL)(From baseline T0 to During-intervention T1 (1 week))
- Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL)(From baseline T0 to Post-intervention T2 (2 weeks))
- Differences of Box and block test(From baseline T0 to During-intervention T1 (1 week))
- Differences of Box and block test(From baseline T0 to Post-intervention T2 (2 weeks))
- Differences of Functional Ambulation Category (FAC)(From baseline T0 to During-intervention T1 (1 week))
- Differences of Functional Ambulation Category (FAC)(From baseline T0 to Post-intervention T2 (2 weeks))
- Differences of Action Research Arm Test (ARAT)(From baseline T0 to During-intervention T1 (1 week))
- Differences of Action Research Arm Test (ARAT)(From baseline T0 to Post-intervention T2 (2 weeks))
- Differences of Jebsen-Taylor hand function test(From baseline T0 to During-intervention T1 (1 week))
- Differences of Jebsen-Taylor hand function test(From baseline T0 to Post-intervention T2 (2 weeks))
- Differences of Hand grip strength test(From baseline T0 to During-intervention T1 (1 week))
- Differences of Hand grip strength test(From baseline T0 to Post-intervention T2 (2 weeks))
研究者
Won Hyuk Chang
Professor
Samsung Medical Center