Stimulate One Hand to Improve Tactile Perception on the Other

Not Applicable

Recruiting

• Conditions: Post-stroke Sensory Deficits at the Hand

• Registration Number: NCT06149325
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-20
• Study First Submitted QC: 2023-11-20
• Study First Posted: 2023-11-29
• Study Start: 2024-04-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-17
• Primary Completion: 2026-05-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Tactile acuity : composite of 2point discrimination test (2PDT) and Absolute threshold detection test after 45minutes of RSS	Immediate after the 45 minutes 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.

Secondary Outcome Measures

Name	Time	Method
Jebsen-Taylor hand function test (JTHFT)	Immediate after the 45 minutes of RSS	Overall functionality of the hand, especially with regard to handling objects
Manual dexterity Pegboard test	Immediate after the 45 minutes of RSS	Assessment of manual dexterity of the affected unstimulated hand (as well as of the spared hand)

Trial Locations

Locations (1)

Groupement Hospitalier du Sud - Hôpital Henry Gabrielle; 🇫🇷 Saint-Genis-Laval, France