Stimulate the Face to Improve Tactile Acuity on the Hand (FACEHAND)
Using a New Form of Cross-border Plasticity Within the Somatosensory Cortex: Stimulate the Face to Improve Tactile Acuity on the Hand
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Saint-Genis-Laval、法国、69230
- Groupement Hospitalier du Sud - Hôpital Henry Gabrielle
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:RSS
Repetitive somatosensory stimulation (RSS)
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Repetitive somatosensory stimulation (RSS) applied on a small region of the face for 3 hours Sham Repetitive somatosensory stimulation (RSS) applied on a small region of the face for 3 hours : the number of stimuli is reduced compared to the effective RSS
其他名称:
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安慰剂比较:Sham RSS
Sham Repetitive somatosensory stimulation (RSS)
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Repetitive somatosensory stimulation (RSS) applied on a small region of the face for 3 hours Sham Repetitive somatosensory stimulation (RSS) applied on a small region of the face for 3 hours : the number of stimuli is reduced compared to the effective RSS
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Tactile acuity : 2 point discrimination test
大体时间:Week 3
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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. |
Week 3
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Tactile acuity : Absolute threshold detection test after 3h of RSS
大体时间:Week 3
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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. |
Week 3
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Jebsen-Taylor hand function test (JTHFT)
大体时间:Week 3
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Overall functionality of the hand, especially with regard to handling objects
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Week 3
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Questionnaire comfort/ease to use
大体时间:Week 3
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A self-reported assessment will be administered after the completion of testing procedure: a custom-made questionnaire including the ease of use, perceived sensations during RSS, easy positioning, pain on removal, positive and negative aspects of RSS, willing to continue using after release from the hospital, and willing to recommend to others.
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Week 3
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合作者和调查者
调查人员
- 首席研究员:Jacques LUAUTE, PU-PH、Service de Médecine Physique et réadaptation
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 69HCL20_0888
- 2020-A03467-32 (其他标识符:ID-RCB)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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