Stimulate One Hand to Improve Tactile Perception on the Other (HAND-HAND)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Post-stroke Sensory Deficits at the Hand

Treatments: Procedure: Sham Repetitive somatosensory stimulation (RSS); Procedure: Repetitive somatosensory stimulation (RSS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06149325

2023-A01994-41 (Other Identifier)

69HCL23_0913

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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25 participants in 2 patient groups

Repetitive somatosensory stimulation (RSS), then SHAM

Experimental group

Description:

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.

Treatment:

Procedure: Repetitive somatosensory stimulation (RSS)

Procedure: Sham Repetitive somatosensory stimulation (RSS)

Sham Repetitive somatosensory stimulation (RSS), then RSS

Experimental group

Description:

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.

Treatment:

Procedure: Repetitive somatosensory stimulation (RSS)

Procedure: Sham Repetitive somatosensory stimulation (RSS)