Using a New Form of Cross-border Plasticity Within the Somatosensory Cortex: Stimulate the Face to Improve Tactile Acuity on the Hand
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Tactile acuity : Absolute threshold detection test after 3h of RSS
研究概览
简要总结
The study is a comparative study, to show that the administration of RSS stimulation on the face compared to the administration of strategy Sham stimulation, results in an temporary improvement in the tactile acuity of the hand in patients with tactile acuity impairment of the hand due to stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double Blind
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 30-80 years old
- •Patients with diagnosis of unilateral (both right and left) ischemic or haemorrhagic stroke
- •Stroke event dates at least 3 months before the date of inclusion to the study
- •Mild-to-moderate sensory loss at the fingers of the hand contralateral to the stroke lesion (affected hand)
- •Capacity to provide written consent
- •Affiliation to a social security scheme
- •Non-Inclusion Criteria:
- •Sensory impairment attributable to diabetes history, peripheral vascular disease or neuropathy
- •Severe speech disorder, global aphasia and/or cognitive impairment
- •Multiple stroke events
- •Bilateral stroke event
- •Hemineglect
- •History of neurological or psychiatric illness
- •Allergy to glue/tape
- •Male participants refusing to shave their moustaches or beards during the study
- •Other experimental procedure is forbidden during the weeks where the study is performed
- •Pregnant, parturient and lactating women
- •Persons deprived of their liberty
- •Adult persons subject to a legal protection measure: guardianship, curatorship
- •Congenital or acquired malformation/injury of the test finger
排除标准
- •Impossibility to maintain hand position necessary for the tests due to severe spasticity
- •Severe impairment of the sensibility of the face preventing the administration of the RSS
- •Severe impairment of the absolute touch detection at the affected hand preventing measurement (threshold 512 mN)
研究组 & 干预措施
RSS
Repetitive somatosensory stimulation (RSS)
干预措施: RSS (Procedure)
Sham RSS
Sham Repetitive somatosensory stimulation (RSS)
干预措施: RSS (Procedure)
结局指标
主要结局
Tactile acuity : Absolute threshold detection test after 3h of RSS
时间窗: Week 3
The Primary outcome measure is a composite of 2point discrimination test (2PDT) and Absolute threshold detection test after 3h of RSS. Spatial discrimination of the finger, Absolute threshold detection of the finger.
Tactile acuity : 2 point discrimination test
时间窗: Week 3
The Primary outcome measure is a composite of 2point discrimination test (2PDT) and Absolute threshold detection test after 3h of RSS. Spatial discrimination of the finger, Absolute threshold detection of the finger.
次要结局
- Jebsen-Taylor hand function test (JTHFT)(Week 3)
- Questionnaire comfort/ease to use(Week 3)