Stimulate the Face to Improve Tactile Acuity on the Hand (FACEHAND)

Using a New Form of Cross-border Plasticity Within the Somatosensory Cortex: Stimulate the Face to Improve Tactile Acuity on the Hand

The study is a comparative study, to show that the administration of RSS stimulation on the face compared to the administration of strategy Sham stimulation, results in an temporary improvement in the tactile acuity of the hand in patients with tactile acuity impairment of the hand due to stroke.

Study Overview

• Status: Unknown
• Conditions: Stroke; Face; RSS
• Intervention / Treatment: Procedure: RSS

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

Contacts and Locations

Study Locations

• France
  • Saint-Genis-Laval, France, 69230
    • Groupement Hospitalier du Sud - Hôpital Henry Gabrielle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age: 30-80 years old
• Patients with diagnosis of unilateral (both right and left) ischemic or haemorrhagic stroke
• Stroke event dates at least 3 months before the date of inclusion to the study
• Mild-to-moderate 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
• Hemineglect
• History of neurological or psychiatric illness
• Allergy to glue/tape
• Male participants refusing to shave their moustaches or beards during the study
• 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
• Congenital or acquired malformation/injury of the test finger

Exclusion Criteria:

• Impossibility to maintain hand position necessary for the tests due to severe spasticity
• Severe impairment of the sensibility of the face preventing the administration of the RSS
• Severe impairment of the absolute touch detection at the affected hand preventing measurement (threshold 512 mN)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RSS; Repetitive somatosensory stimulation (RSS)	Procedure: RSS; Repetitive somatosensory stimulation (RSS) applied on a small region of the face for 3 hours Sham Repetitive somatosensory stimulation (RSS) applied on a small region of the face for 3 hours : the number of stimuli is reduced compared to the effective RSS; Other Names: Repetitive somatosensory stimulation (RSS); Sham Repetitive somatosensory stimulation (RSS)
Placebo Comparator: Sham RSS; Sham Repetitive somatosensory stimulation (RSS)	Procedure: RSS; Repetitive somatosensory stimulation (RSS) applied on a small region of the face for 3 hours Sham Repetitive somatosensory stimulation (RSS) applied on a small region of the face for 3 hours : the number of stimuli is reduced compared to the effective RSS; Other Names: Repetitive somatosensory stimulation (RSS); Sham Repetitive somatosensory stimulation (RSS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tactile acuity : 2 point discrimination test	The Primary outcome measure is a composite of 2point discrimination test (2PDT) and Absolute threshold detection test after 3h of RSS. Spatial discrimination of the finger, Absolute threshold detection of the finger.	Week 3
Tactile acuity : Absolute threshold detection test after 3h of RSS	The Primary outcome measure is a composite of 2point discrimination test (2PDT) and Absolute threshold detection test after 3h of RSS. Spatial discrimination of the finger, Absolute threshold detection of the finger.	Week 3

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	Week 3
Questionnaire comfort/ease to use	A self-reported assessment will be administered after the completion of testing procedure: a custom-made questionnaire including the ease of use, perceived sensations during RSS, easy positioning, pain on removal, positive and negative aspects of RSS, willing to continue using after release from the hospital, and willing to recommend to others.	Week 3

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Jacques LUAUTE, PU-PH, Service de Médecine Physique et Réadaptation

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): February 21, 2023

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: February 5, 2021
• First Posted (Actual): February 9, 2021

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 5, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 69HCL20_0888; 2020-A03467-32 (Other Identifier: ID-RCB)

Drug and device information, study documents

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