Neuroplastic Changes and Effects of Intermittent Theta Burst Stimulation (iTBS) on Motor Recovery of Upper and Lower Extremity in Chronic Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- miniBest test
研究概览
简要总结
This study aims to evaluate the effects and clinical feasibility of non-invasive brain stimulation protocols, specifically intermittent Theta Burst Stimulation, as part of rehabilitation interventions for motor recovery of lower extremity in the chronic phase after stroke.
It also seeks to explore the underlying mechanisms by investigating changes of functional and structural brain networks.
详细描述
In this randomized control trial (RCT) group A will receive iTBS while group B will receive sham iTBS. Both groups will directly after the intervention receive 45 minutes of conventional physical therapy 3 times per week for 5 weeks, a total of 15 interventions by a blinded physiotherapist. For the iTBS intervention a Magstim Rapid² stimulator will be used also equipped with a Cadwell Sierra Summit EMG system [for motor evoked potential (MEP) measurements] and an ANT Visor2™ neuronavigation system [for navigated transcranial magnetic stimulation (TMS) interventions]. The iTBS parameters that will be used are: 600 pulses under 190 seconds at 80 % of Active Motor Threshold (AMT). The contralesional cerebellum will be targeted. The participants and clinical assessors will be blinded to the intervention.
All the patients will undergo advanced neuroimaging examinations before and after the intervention period. The exams will be then compared to identify neuroplastic changes in brain circuits.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18
- •Chronic stroke (>6 months)
- •Residual hemiparesis FAC ≥3
排除标准
- •Metal implants
- •Epilepsy/seizures
- •Pregnancy
- •Claustrophobia (related to MRIs exams)
- •Severe cognitive impairment
- •Untreated or unstable depression/anxiety
- •Other disabilities prohibiting intensive physical training
结局指标
主要结局
miniBest test
时间窗: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.
measures dynamic balance, functional mobility, and gait. It is a 14-item test scored on a 3-level ordinal scale. The score ranges from 0 to 28 points. A higher score indicates better balance.
miniBest test
时间窗: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.
measures dynamic balance, functional mobility, and gait. It is a 14-item test scored on a 3-level ordinal scale. The score ranges from 0 to 28 points. A higher score indicates better balance.
次要结局
- Fugl-Meyer Assessment - Lower Extremity(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Modified Ashworth Scale (MAS)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Neuroflexor(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Lower Extremity Motor Coordination Test (LEMOCOT)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- 6 minutes walk test(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Functional Ambulation Categories (FAC)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Falls Efficacy Scale Swedish version (FES-S)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Walking impact scale (MSWS-12 S)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Canadian Occupational Performance Measure(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Montreal Cognitive Assessment (MoCA)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Stroke Impact Scale (SIS)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Motor Evoked Potentials (MEPs)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Resting state functional MRI (rs-fMRI)(At baseline and after completion of the 5 week intervention to assess changes.)
- Neuroflexor(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Fugl-Meyer Assessment - Lower Extremity(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Modified Ashworth Scale (MAS)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Falls Efficacy Scale Swedish version (FES-S)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Stroke Impact Scale (SIS)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Lower Extremity Motor Coordination Test (LEMOCOT)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- 6 minutes walk test(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Functional Ambulation Categories (FAC)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Walking impact scale (MSWS-12 S)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Canadian Occupational Performance Measure(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Montreal Cognitive Assessment (MoCA)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Motor Evoked Potentials (MEPs)(At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.)
- Resting state functional MRI (rs-fMRI)(At baseline and after completion of the 5 week intervention to assess changes.)
- Diffusion Tensor Imaging (DTI)(At baseline and after completion of the 5 week intervention to assess changes)
研究者
Susanne Palmcrantz
PhD, Associate Professor, Reg Physiotherapist
Danderyd Hospital