NCT04745247

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2023

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

Same day

First QC Date

January 26, 2021

Last Update Submit

February 5, 2021

Conditions

StrokeRSSFace

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Jebsen-Taylor hand function test (JTHFT)

    Week 3

  • Questionnaire comfort/ease to use

    Week 3

Study Arms (2)

RSS

EXPERIMENTAL

Repetitive somatosensory stimulation (RSS)

Procedure: RSS

Sham RSS

PLACEBO COMPARATOR

Sham Repetitive somatosensory stimulation (RSS)

Procedure: RSS

Interventions

RSSPROCEDURE

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

Also known as: Repetitive somatosensory stimulation (RSS), Sham Repetitive somatosensory stimulation (RSS)
RSSSham RSS

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 30-80 years old
  • Patients with diagnosis of unilateral (both right and left) ischemic or haemorrhagic stroke
  • 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
  • +3 more criteria

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupement Hospitalier du Sud - Hôpital Henry Gabrielle

Saint-Genis-Laval, 69230, France

Location

MeSH Terms

Conditions

StrokeFacies

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jacques LUAUTE, PU-PH

    Service de Médecine Physique et Réadaptation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacques LUAUTE, PU-PH

CONTACT

4 78 86 50 23jacques.luaute@chu-lyon.fr

Gilles RODE, PU-PH

CONTACT

4 78 86 50 66gilles.rode@chu-lyon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double Blind
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2021

First Posted

February 9, 2021

Study Start

February 1, 2021

Primary Completion

February 1, 2021

Study Completion

February 21, 2023

Last Updated

February 9, 2021

Record last verified: 2021-02

Locations

FR(1)