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

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.

Study Overview

• Status: Recruiting
• Conditions: Post-stroke Sensory Deficits at the Hand
• Intervention / Treatment: Procedure: Repetitive somatosensory stimulation (RSS); Procedure: Sham Repetitive somatosensory stimulation (RSS)

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacques LUAUTE, Pr; Phone Number: +33 4 78 86 50 23; Email: jacques.luaute@chu-lyon.fr
• Study Contact Backup: Name: Malika Azaroual-Sentucq, PhD student; Phone Number: +33 4 72 91 34 03; Email: malika.azaroual@inserm.fr

Study Locations

• France
  • Saint-Genis-Laval, France, 69230
    • Recruiting
    • Groupement Hospitalier du Sud - Hôpital Henry Gabrielle
    • Contact: Jacques LUAUTE, Pr; Phone Number: +33 4 78 86 50 23; Email: jacques.luaute@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Repetitive somatosensory stimulation (RSS); Tactile stimuli on the index finger of the intact hand, for a duration of 45 minutes; Procedure: Sham Repetitive somatosensory stimulation (RSS); Tactile stimuli on the index finger of the intact hand, for a duration of 4 minutes spread over 45 minutes in 6 blocks of 40 seconds
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.	Procedure: Repetitive somatosensory stimulation (RSS); Tactile stimuli on the index finger of the intact hand, for a duration of 45 minutes; Procedure: Sham Repetitive somatosensory stimulation (RSS); Tactile stimuli on the index finger of the intact hand, for a duration of 4 minutes spread over 45 minutes in 6 blocks of 40 seconds

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 29, 2023

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; Sensory deficits; RSS
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 69HCL23_0913; 2023-A01994-41 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No