Effects of Trans-Auricular Vagal Stimulation on Neuromotor Recovery Post-Stroke in the Subacute Phase During Training With the Khymeia Technological Device and Traditional Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Upper limb motor recovery assessed by Fugl-Meyer Assessment (FMA-UE)
研究概览
简要总结
This randomized pilot clinical study aims to investigate the effects of trans-auricular vagus nerve stimulation (tVNS) on neuromotor recovery in patients in the subacute phase after stroke. Participants admitted for intensive rehabilitation at ICS Maugeri Centers (Montescano, Pavia, Nervi) will be randomized into four groups receiving either traditional or technological rehabilitation (Khymeia device), combined with active or sham tVNS.
The Parasym® device (CE 0197) delivers non-invasive stimulation of the auricular branch of the vagus nerve at the left ear for 60 minutes daily.
The primary outcome is the improvement in upper limb motor function, assessed by the Fugl-Meyer scale. Secondary outcomes include other clinical, cognitive, and psychological measures, as well as neurophysiological and cardiovascular autonomic parameters.
The study hypothesizes that coupling tVNS with rehabilitation enhances cortical plasticity and accelerates motor recovery. Adverse effects are expected to be minimal, with previous studies reporting only mild transient skin irritation. The results may provide new insights into the neurophysiological mechanisms of recovery and support the integration of non-invasive neuromodulation in post-stroke rehabilitation.
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, 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
- •Patients with hemiplegia following ischemic or hemorrhagic stroke occurred within the previous 6 months, clinically stable
- •Age ≥ 18 years
- •Single cortical or subcortical lesion documented on neuroimaging, corresponding to the motor deficit
- •Cognitively able to understand and follow therapeutic instructions
- •Upper limb weakness confirmed by a Motricity Index score below maximum
- •Spasticity, if present, compatible with limb function (Modified Ashworth Scale ≤ 2)
- •Written informed consent provided
排除标准
- •Multiple brain lesions on neuroimaging
- •Severe spasticity (Modified Ashworth Scale 3-4)
- •Aphasia preventing comprehension of verbal instructions
- •Cognitive decline or behavioral disorders interfering with collaboration during training
- •Orthopedic conditions or surgical outcomes preventing the execution of the rehabilitation training
研究组 & 干预措施
Traditional Rehabilitation + Active tVNS
干预措施: Active trans-auricular vagus nerve stimulation (tVNS) (Device)
Traditional Rehabilitation + Active tVNS
干预措施: Traditional Rehabilitation (Behavioral)
Traditional Rehabilitation + Sham tVNS
干预措施: Sham tVNS (Device)
Traditional Rehabilitation + Sham tVNS
干预措施: Traditional Rehabilitation (Behavioral)
Khymeia + Active tVNS
干预措施: Active trans-auricular vagus nerve stimulation (tVNS) (Device)
Khymeia + Active tVNS
干预措施: Khymeia robotic upper limb rehabilitation (Device)
Khymeia + Sham tVNS
干预措施: Sham tVNS (Device)
Khymeia + Sham tVNS
干预措施: Khymeia robotic upper limb rehabilitation (Device)
结局指标
主要结局
Upper limb motor recovery assessed by Fugl-Meyer Assessment (FMA-UE)
时间窗: Baseline and 4 weeks after treatment
The FMA-UE is a scale used to measure sensorimotor impairment. Scores range from 0 to 66, where higher scores indicate better motor function.
次要结局
- Mini-Mental State Examination (MMSE)(Baseline and 4 weeks)
- Frontal Assessment Battery (FAB)(Baseline and 4 weeks)
- Barthel Index(Baseline and 4 weeks)
- Functional Independence Measure (FIM)(Baseline and 4 weeks.)
- Somatosensory Evoked Potentials (Median Nerve)(Baseline and 4 weeks)
- Patient Health Questionnaire-9 (PHQ-9)(Baseline and 4 weeks)
- Generalized Anxiety Disorder-7 (GAD-7)(Baseline and 4 weeks)