Stimulate One Hand to Improve Tactile Perception on the Other

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 80
Healthy Volunteers: f
View:

‣ 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

Locations
Other Locations
France
Groupement Hospitalier du Sud - Hôpital Henry Gabrielle
RECRUITING
Saint-genis-laval
Contact Information
Primary
Jacques LUAUTE, Pr
jacques.luaute@chu-lyon.fr
4 78 86 50 23
Backup
Malika Azaroual-Sentucq, PhD student
malika.azaroual@inserm.fr
4 72 91 34 03
Time Frame
Start Date: 2024-04-30
Estimated Completion Date: 2026-05-30
Participants
Target number of participants: 25
Treatments
Experimental: Repetitive somatosensory stimulation (RSS), then SHAM
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.
Experimental: Sham Repetitive somatosensory stimulation (RSS), then RSS
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.
Related Therapeutic Areas
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov