NCT06826274尚未招募不适用
Clinical and Neurophysiological Evaluation of the Effects of Cervical TsDCS on Stroke Patients with Distal Upper Limb Strength Deficit
IRCCS San Raffaele Roma1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- improvement of paretic hand performance
研究概览
简要总结
The present project aims to evaluate the facilitatory modulation of motor responses of the limb upper limb by tsDCS in patients with arm/hand hyposthenia after cerebral ischemia to verify the possible therapeutic benefits that this type of stimulation can induce in terms of of strength, dexterity and effectiveness in acts of daily living.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group Stroke:
- •Inclusion criteria:
- •age over 18 years;
- •first ischemic/hemorrhagic stroke (within 30 days of onset);
- •mild-to-moderate stroke (NIHSS scale score<16).
- •residual function of the upper limb, assessed by the following scales: - MRC of the distal muscles of the upper limb: score between 2 and 4; - NHISS (items 5A and 5B): score between 1 and 3;
- •ability to give informed consent and understand instructions.
排除标准
- •severe spasticity (Ashworth Scale score > 2);
- •severe aphasia;
- •severe neglect;
- •history of disabling neurological disease;
- •history of epilepsy;
- •significant comorbidities;
- •contraindications to tsDCS.
- •Healthy Group:
- •Inclusion criteria:
- •age over 18 years;
- •equalized in age with the patient group.
- •Exclusion criteria:
- •history of stroke progress;
- •history of severe neurological disease.
研究组 & 干预措施
Healthy
Experimental
干预措施: tDCS (Other)
Stroke
Experimental
干预措施: tDCS (Other)
结局指标
主要结局
improvement of paretic hand performance
时间窗: through study completion, an average of 1 year
The primary outcome measure is the improvement in hand strength and dexterity in individuals with upper limb motor impairment following cerebral ischemia, after the application of tsDCS at the cervical spinal level during Reaching
次要结局
未报告次要终点
研究者
研究点 (1)
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