Clinical trial NCT06149325: Stimulate One Hand to Improve Tactile Perception on the Other
Official title: Stimulate One Hand to Improve Tactile Perception on the Other
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-stroke Sensory Deficits at the Hand
Keywords: Stroke
Sensory deficits
RSS
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 25
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Tactile acuity : composite of 2point discrimination test (2PDT) and Absolute threshold detection test after 45minutes of RSS
timeFrame: Immediate after the 45 minutes of RSS
Secondary outcomes:
measure: Jebsen-Taylor hand function test (JTHFT)
timeFrame: Immediate after the 45 minutes of RSS
measure: Manual dexterity Pegboard test
timeFrame: Immediate after the 45 minutes of RSS
Other outcomes:
Locations:
city: Saint-Genis-Laval
country: France
facility: Groupement Hospitalier du Sud - Hôpital Henry Gabrielle
Study officials:
References: