Clinical, Electrophysiological and E-field Modelling Evidence of High Density Transcranial Direct Current Stimulation in Motor Stroke
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pre-to-post intervention change on motor skills. To measure such domain, the Fugl-Meyer assessment (FMA) will be used.
研究概览
简要总结
The present study aims to investigate the therapeutic potential of a high definition transcranial direct current stimulation protocol, stimulating frontal and cerebellar areas boosting the cognitive and motor recovery of stroke population.
详细描述
Stroke cause direct network dysfunctions correlating with the underlying behavioral deficits In that context, characterize and boost neuronal reshaping towards a favorable state for recovery has become a distinguished therapeutic approach. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation able to locally modulate neuronal activity and modify neural arquitecture.
In such scenario, the investigators develop in this protocol a new tDCS multitarget fronto-cerebellar tDCS approach, exploring the benefits of boosting motor dysfunctions by means of a dual site-approach, up-regulating dlPFC and CB activity. The investigators here design a pilot experimental clinical trial exploring the accumulative clinical potential for motor skill & learning recovery and EEG effects of a high-density bifocal transcranial direct current stimulation protocol (HD-tDCS).
The investigators hypothesize that the tDCS protocol will promote direct functional motor reorganization helping relearning motor process, will boost the activity of prefrontal settled systems correcting attentional deficits and increasing strength connectivity with premotor systems, and will normalize large-scale abnormalities increasing interhemispheric functional connectivity (i.e., functional integration), decreasing interhemispheric asymmetry (i.e., functional segregation) and restoring transcallosal balance, impacting positively either in motor and cognitive recovery. All in all, this study will be the first exploring the simultaneous modulation of two different targets in stroke population corresponding to different networks looking for a summative/synergistic effects helping motor and cognitive functions recovery.
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, Investigator)
盲法说明
Double blind
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
- •Received a diagnosis of supratentorial ischemic or hemorrhagic stroke confirmed by neuroimage (MRI, PET, CT, fMRI or DTI) in the middle cerebral artery territory or encompassing fronto-temporo-parietal hemorrhages
- •Enrolled in a live rehabilitation program in the rehabilitation and physical medicine department
- •Between 4 and 12 months after stroke episode
- •Have signed the informed form
排除标准
- •Medical instability with the presence of infections, assisted ventilation, epilepsy or recurrent seizures, untreated psychiatric disorders or an active treatment with sedative drugs
- •tDCS contraindications as defined by the international safety guidelines
- •Large aphasic, psychiatric and cognitive deficits limiting patient's comprehension
结局指标
主要结局
Pre-to-post intervention change on motor skills. To measure such domain, the Fugl-Meyer assessment (FMA) will be used.
时间窗: Baseline (W0) 3 days pre-intevention onset, post-intervention (W3) 3 days post-intervention finalization, and 30 days (W7) post-intervention finalization.
The Fugl Meyer is a widely used scale to asses motor impairment on post-stroke patients and is considered one of the most comprehensive and reliable quantitative measures for motor hemiplegic dysfunctions 61. The FMA provides an incapacity index divided in five sub-scales encompassing the assessment of functional motricity, sensibility, balance, joint range and joint pain. Among the sub-sections of the scale, we will only use the functional motricity assessment to evaluate the motor domain, including the upper extremity (FMA-UE) and the lower extremity (FMA-LE). The FMA-UE and FMA-LE include a series of items measuring movement, coordination and reflexes.
次要结局
- Pre-to-post intervention change on cognitive abilities. To measure such domain the Montreal cognitive assessment (MoCA) will be used.(Baseline (W0) 3 days pre-intevention onset, post-intervention (W3) 3 days post-intervention finalization, and 30 days (W7) post-intervention finalization.)
- Pre-to-post intervention change on neglect impairment. To measure such domain, the letter cancelation test, the bell cancelation test and the line bisection test will be used.(Baseline (W0) 3 days pre-intevention onset, post-intervention (W3) 3 days post-intervention finalization, and 30 days (W7) post-intervention finalization.)
- Pre-to-post intervention modualtion of resting-state and task-engaged power spectral frequency, functional connectivity and entropy. To measure such domains, a electroencephalography (EEG) analysis will be conducted.(Baseline (W0) 3 days pre-intevention onset, post-intervention (W3) 3 days post-intervention finalization, and 30 days (W7) post-intervention finalization.)
- Pre-to-post intervention change on cognitive abilities.To measure such domain. the AX-continuous performance task (AX-CPT) will be used.(Baseline (W0) 3 days pre-intevention onset, post-intervention (W3) 3 days post-intervention finalization, and 30 days (W7) post-intervention finalization.)
- Pre-to-post intervention change on global stroke impairment. To measure such domain the National institutes of health stroke scale (NIHSS) will be used.(Baseline (W0) 3 days pre-intevention onset, post-intervention (W3) 3 days post-intervention finalization, and 30 days (W7) post-intervention finalization.)
- Pre-to-post intervention change on motor adaptation skills. To measure such domain, a computer-based visuo-motor task will be used.(Baseline (W0) 3 days pre-intevention onset, post-intervention (W3) 3 days post-intervention finalization, and 30 days (W7) post-intervention finalization.)
- Correlations between the electric field impact and the changes in the behavioral outcomes (clinical outcomes and eeg response). To perform such correlations, individual simulated biophysical models of electric stimulation distribution will be conducted.(MRI will be acquired 2 weeks before treatment onset or from the medical database.)
研究者
Xavier Corominas
Principal investigator
University Rovira i Virgili