Stimulate the Face to Improve Tactile Acuity on the Hand

Study Overview
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Brief Summary
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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.

Official Title
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Using a New Form of Cross-border Plasticity Within the Somatosensory Cortex: Stimulate the Face to Improve Tactile Acuity on the Hand

Conditions
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Stroke, RSS, Face

Intervention / Treatment
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* Procedure: RSS


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RSS<br>Repetitive somatosensory stimulation (RSS) | Procedure: RSS<br>* 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<br>* Other names: Sham Repetitive somatosensory stimulation (RSS);|
| Placebo Comparator: Sham RSS<br>Sham Repetitive somatosensory stimulation (RSS) | Procedure: RSS<br>* 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<br>* Other names: Sham Repetitive somatosensory stimulation (RSS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tactile acuity : 2 point discrimination test | 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 | 
| Tactile acuity : Absolute threshold detection test after 3h of RSS | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jebsen-Taylor hand function test (JTHFT) | Overall functionality of the hand, especially with regard to handling objects | Week 3 | 
| Questionnaire comfort/ease to use | 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. | Week 3 |