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NCT06149325 | RECRUITING | Post-stroke Sensory Deficits at the Hand

Stimulate One Hand to Improve Tactile Perception on the Other
Sponsor:

Lyon Civilian Hospices

Brief 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.

Condition or disease

Post-stroke Sensory Deficits at the Hand

Intervention/treatment

Repetitive somatosensory stimulation (RSS)

Sham Repetitive somatosensory stimulation (RSS)

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 25 participants
Masking : DOUBLE
Masking Description : 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.
Primary Purpose : BASIC_SCIENCE
Official Title : Stimulate One Hand to Improve Tactile Perception on the Other
Actual Study Start Date : 2024-04-30
Estimated Primary Completion Date : 2026-05-30
Estimated Study Completion Date : 2026-05-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 30 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
* 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
Stimulate One Hand to Improve Tactile Perception on the Other

Location Details

NCT06149325

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How to Participate

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Locations

RECRUITING

France,

Hospital group of the South - Hénry Gabrielle Hospital

Saint-Genis-Laval, France, 69230