Stimulate the Face to Improve Tactile Acuity on the Hand

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2023-02-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Stroke RSS Face

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double Blind

Study Groups

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RSS

Repetitive somatosensory stimulation (RSS)

Group Type EXPERIMENTAL

RSS

Intervention Type PROCEDURE

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

Sham RSS

Sham Repetitive somatosensory stimulation (RSS)

Group Type PLACEBO_COMPARATOR

RSS

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Other Intervention Names

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Repetitive somatosensory stimulation (RSS) Sham Repetitive somatosensory stimulation (RSS)

Eligibility Criteria

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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

* 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)

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No