Stimulate the Face to Improve Tactile Acuity on the Hand

Not Applicable

• Conditions: Stroke; Face; RSS
• Interventions: Procedure: RSS

• Registration Number: NCT04745247
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-26
• Status Verified: 2021-02
• Study Start: 2021-02-01
• Primary Completion: 2021-02-01
• Study First Submitted QC: 2021-02-05
• Last Update Submitted: 2021-02-05
• Study First Posted: 2021-02-09
• Last Update Posted: 2021-02-09
• Study Completion: 2023-02-21

Recruitment & Eligibility

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

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham RSS	RSS	Sham Repetitive somatosensory stimulation (RSS)
RSS	RSS	Repetitive somatosensory stimulation (RSS)

Primary Outcome Measures

Name	Time	Method
Tactile acuity : Absolute threshold detection test after 3h of RSS	Week 3	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.
Tactile acuity : 2 point discrimination test	Week 3	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.

Secondary Outcome Measures

Name	Time	Method
Jebsen-Taylor hand function test (JTHFT)	Week 3	Overall functionality of the hand, especially with regard to handling objects
Questionnaire comfort/ease to use	Week 3	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.

Trial Locations

Locations (1)

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