Stimulate One Hand to Improve Tactile Perception on the Other

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 one hand compared to the administration of strategy Sham stimulation, results in an temporary improvement in the tactile acuity of the other hand in patients with tactile acuity impairment of the hand due to stroke.

Official Title
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Stimulate One Hand to Improve Tactile Perception on the Other

Conditions
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Post-stroke Sensory Deficits at the Hand

Intervention / Treatment
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* Procedure: Repetitive somatosensory stimulation (RSS)
* Procedure: Sham Repetitive somatosensory stimulation (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 hemorrhagic stroke Stroke event dates at least 3 months before the date of inclusion to the study Severe-to-mild 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 History of neurological or psychiatric illness 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 Persons in psychiatric care Congenital or acquired malformation/injury of the test fingers Impossibility to maintain hand position necessary for the tests due to severe spasticity Exclusion Criteria: • Severe impairment of the sensibility of the index finger of the spared hand preventing the administration of the RSS

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
Interventional Model Description: The study is a comparative study, to show that the administration of RSS stimulation leads to a better performance compared to the administration of Sham stimulation (control). The participant's performance after receiving Sham stimulation will be unchanged compared to the baseline performance measured before the stimulation. On the contrary, participant's performance after receiving RSS stimulation will show a considerable improvement compared to the baseline performance, proving the superiority of RSS stimulation over the control. The study has a cross-over design, where each participant receives both stimulations, on different days. The two stimulations will be administered in a randomized order across participants, and in double-blind.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Repetitive somatosensory stimulation (RSS), then SHAM<br>Adult patients suffering from post-stroke sensory deficits at the hand. Each participant will participate to the study on two different days, at least a week apart from each other. The length of the experimental session on these two days will be the same: 2 hours in the morning, to perform Pre-evaluation of the tactile acuity, absolute detection, overall hand functionality and manual dexterity, and 3 hours in the afternoon, including 45 minutes of stimulation (RSS or Sham) and 2 hours of Post-evaluation of the tactile acuity, absolute detection, overall hand functionality and manual dexterity. In total, the length of the participation of each patient will be of 10 hours, spread on two days. | Procedure: Repetitive somatosensory stimulation (RSS)<br>* Tactile stimuli on the index finger of the intact hand, for a duration of 45 minutes<br>Procedure: Sham Repetitive somatosensory stimulation (RSS)<br>* Tactile stimuli on the index finger of the intact hand, for a duration of 4 minutes spread over 45 minutes in 6 blocks of 40 seconds<br>|
| Experimental: Sham Repetitive somatosensory stimulation (RSS), then RSS<br>Adult patients suffering from post-stroke sensory deficits at the hand. Each participant will participate to the study on two different days, at least a week apart from each other. The length of the experimental session on these two days will be the same: 2 hours in the morning, to perform Pre-evaluation of the tactile acuity, absolute detection, overall hand functionality and manual dexterity, and 3 hours in the afternoon, including 45 minutes of stimulation (RSS or Sham) and 2 hours of Post-evaluation of the tactile acuity, absolute detection, overall hand functionality and manual dexterity. In total, the length of the participation of each patient will be of 10 hours, spread on two days. | Procedure: Repetitive somatosensory stimulation (RSS)<br>* Tactile stimuli on the index finger of the intact hand, for a duration of 45 minutes<br>Procedure: Sham Repetitive somatosensory stimulation (RSS)<br>* Tactile stimuli on the index finger of the intact hand, for a duration of 4 minutes spread over 45 minutes in 6 blocks of 40 seconds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tactile acuity : composite of 2point discrimination test (2PDT) and Absolute threshold detection test after 45minutes of RSS | To show that RSS applied for 45 minutes on the index finger of the spared hand in stroke patients suffering from sensory deficits improves their tactile sensitivity on the affected (unstimulated) hand, measured in terms of improved spatial discrimination and/or improved absolute detection. | Immediate after the 45 minutes of RSS | 

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 | Immediate after the 45 minutes of RSS | 
| Manual dexterity Pegboard test | Assessment of manual dexterity of the affected unstimulated hand (as well as of the spared hand) | Immediate after the 45 minutes of RSS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Sensory deficits, RSS