Association of Dual Transcranial Electrical Stimulation (tDCS) to Upper Limb Robotic Therapy in Individuals With Chronic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Significant Fugl-Meyer Assessment Upper Extremity (FMA-UE) improvement in real dual tDCS group vs sham tDCS group
研究概览
简要总结
The two cerebral hemispheres find themselves in a state of balanced mutual inhibition. A stroke with involvement of motor function leads to a reduced excitability in affected hemisphere M1 and to an increased excitability of contralateral M1. Stroke therefore might impair interhemispheric balance, leading to a decreased inhibition of contralesional hemisphere by ipsilesional hemisphere and, in turn, to an increased inhibition of ipsilesional hemisphere by contralesional hemisphere. Permanence of healthy hemisphere hyperactivation in chronic phase after stroke is usually index of little functional recovery and is correlated with a greater ipsilateral structural damage.
Robot-mediated physical therapy is an innovative rehabilitation technique that is effective in stroke patients. In this study, the investigators will add a non-invasive brain stimulation protocol with Transcranial stimulation with direct current (tDCS) to the robotic treatment in chronic stroke patients. tDCS is a non-invasive brain stimulation technique that is able to modulate cortical excitability. The hypothesis is that dual t-DCS (ipsilesional excitation and concomitant contralesional inhibition) could restore interhemispheric balance improving the benefits of robotic therapy with Armeo Power®.
详细描述
The general theory of the inhibitory interhemispheric competition speculates that, under physiological conditions, the two cerebral hemispheres find themselves in a state of balanced mutual inhibition. Accordingly, some electrophysiological and functional imaging studies have shown that a stroke with involvement of motor function leads to a reduced excitability in affected hemisphere M1 and to an increased excitability of contralateral M1. Stroke therefore might impair interhemispheric balance, leading to a decreased inhibition of contralesional hemisphere by ipsilesional hemisphere and, in turn, to an increased inhibition of ipsilesional hemisphere by contralesional hemisphere.
This imbalance in cerebral hemispheres excitability tends to decline over the functional recovery in the first months after stroke, in proportion to the functional recovery of the ipsilateral structures.
Alternatively, permanence of healthy hemisphere hyperactivation in chronic phase after stroke is usually index of little functional recovery and is correlated with a greater structural damage to the ipsilesional corticospinal tract and transcallosal fibers, although some studies have suggested a vicarious role of healthy hemisphere.
Recently, some authors have proposed a structural reserve-based bimodal model of recovery, for which the vicarious model would be valid only for patients with poor structural reserves (and therefore more extensive damage), while the interhemispheric competition model would be valid for patients with larger structural reserves.
In the light of these data, it is conceivable that procedures aiming at promoting the re-establishment of a normal balance in interhemispheric interaction can facilitate motor function recovery of the paretic limb, at least in patients with appropriate structural reserves.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Subjects with isolated ischemic stroke, confirmed by brain imaging (MRI, CT)
- •subjects who retain sufficient cognitive functions and language to follow the instructions given by doctors and therapists
- •subjects with basal Modified Ashworth Scale score under 3
- •subjects with basal Fugl-Meyer score ≥ 3 so that they are not completely paralyzed
- •subjects who have signed informed consent to participate in this study
- •subjects that show stable conditions in the two pre-treatment evaluations, in order to avoid "Hawthorne effect"
排除标准
- •subjects with chronic paretic limb deformities
- •subjects with complete and flaccid paralysis of all motor performances of shoulder and elbow;
- •subjects with severe hemineglect (Pizzamiglio battery for unilateral spatial neglect including letter cancellation test, barrage tests, reading and Wundt-Jastro area illusion test; patients diagnosed with neglect if 3 of 4 items of this battery are present)
- •subjects showing an increase in the Fugl-Meyer more than 2.1 points in the second pre-treatment clinical evaluation, compared to the score of the first evaluation
- •subjects with contraindications to the execution of transcranial magnetic stimulation - TMS - (pacemakers, metal implants)
- •subjects with epilepsy
- •Previous neurosurgical interventions
- •Severe upper limb osteoporosis
- •Upper limb strength or joint movement limitation due to previous fractures
- •Upper limb strength or joint movement limitation due to previous surgical interventions
- •Mini Mental State Evaluation (MMSE) <24
结局指标
主要结局
Significant Fugl-Meyer Assessment Upper Extremity (FMA-UE) improvement in real dual tDCS group vs sham tDCS group
时间窗: first assessment will occur within 2 days from enrollment, and will be repeated within 2 days from the end of 2 week-training and at 1 and 3 months follow-up
次要结局
- Significant Modified Ashworth scale improvement in real dual tDCS group vs sham tDCS group(first assessment will occur within 2 days from enrollment, and will be repeated within 2 days from the end of 2 week-training and at 1 and 3 months follow-up)
- Significant rebalancing of motor evoked potential (MEP) laterality index in real dual tDCS group vs sham tDCS group(first assessment will occur within 2 days from enrollment, and will be repeated within 2 days from the end of 2 week-training)
- Significant kinematic performance improvement, measured by ArmeoPower®, in real dual tDCS group vs sham tDCS group(first assessment will occur within 2 days from enrollment, and will be repeated within 2 days from the end of 2 week-training)
- Significant Action Research Arm Test (ARAT) improvement in real dual tDCS group vs sham tDCS group(first assessment will occur within 2 days from enrollment, and will be repeated within 2 days from the end of 2 week-training and at 1 and 3 months follow-up)
- Significant Barthel index improvement in real dual tDCS group vs sham tDCS group(first assessment will occur within 2 days from enrollment, and will be repeated within 2 days from the end of 2 week-training and at 1 and 3 months follow-up)
研究者
Giovanni Morone, MD, PhD
MD, PhD
I.R.C.C.S. Fondazione Santa Lucia