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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A01994-41 | Other Identifier | ID-RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repetitive somatosensory stimulation (RSS), then SHAM | Experimental | 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. |
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| Sham Repetitive somatosensory stimulation (RSS), then RSS | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive somatosensory stimulation (RSS) | Procedure | Tactile stimuli on the index finger of the intact hand, for a duration of 45 minutes |
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| 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 |
| 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) |
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Inclusion Criteria:
Non inclusion Criteria * :
Exclusion Criteria:
• Severe impairment of the sensibility of the index finger of the spared hand preventing the administration of the RSS
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacques LUAUTE, Pr | Contact | 4 78 86 50 23 | +33 | jacques.luaute@chu-lyon.fr |
| Malika Azaroual-Sentucq, PhD student | Contact | 4 72 91 34 03 | +33 | malika.azaroual@inserm.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupement Hospitalier du Sud - Hôpital Henry Gabrielle | Recruiting | Saint-Genis-Laval | 69230 | France |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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Experimenter 2 will be in charge of the randomization. He will establish a randomization list through Excel and assign to each patient one of the two possible order (Day 1 RSS / Day 2 Sham OR Day 1 Sham / Day 2 RSS). This Excel will be protected through a password and kept in the CRNL server. He will then fill the envelopes with the order assigned by the randomization list and seal them. Each envelope is assigned an inclusion number.
On the inclusion visit (J0), once the consent form is signed, the sealed envelope will be kept in the medical file of the patient. On the first visit (J1). Experimenter 1 will assess the performance of the patient through the tactile and motor tests, while the Exp2 will be in charge of applying the stimulation.
Once Exp1 finished doing the tactile and motor tasks, she will leave the room and Exp2 will enter in the room, open the sealed envelope and apply the stimulation. He will stay in the room with the patient during the stimulation duration.
| Sham Repetitive somatosensory stimulation (RSS) | Procedure | 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 |
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| Immediate after the 45 minutes of RSS |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |