StrokeFACEHANDNCT04745247
Stimulate the Face to Improve Tactile Acuity on the Hand
A study testing RSS in people with Stroke and RSS, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- What is being tested?
- RSS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2021to 21 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site
Groupement Hospitalier du Sud - Hôpital Henry Gabrielle
Saint-Genis-Laval, 69230
Jacques LUAUTE, PU-PH, 4 78 86 50 23 ext. +33, jacques.luaute@chu-lyon.fr
Jacques LUAUTE, PU-PH
About this study
Official title: 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.
- Being tested
- RSS
- Medical subject headings
- Stroke, Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSSProcedure or surgery
Also called Repetitive somatosensory stimulation (RSS), Sham Repetitive somatosensory stimulation (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
| Study group | Role | What they receive |
|---|---|---|
| RSS | Experimental | Repetitive somatosensory stimulation (RSS) Receives: Procedure: RSS |
| Sham RSS | Placebo comparator | Sham Repetitive somatosensory stimulation (RSS) Receives: Procedure: RSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 3
Secondary outcomes (2)
Jebsen-Taylor hand function test (JTHFT)
Overall functionality of the hand, especially with regard to handling objects
Measured: 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.
Measured: Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Feb 2021 (estimated)
- Primary completion1 Feb 2021 (estimated)
- Study completion21 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques LUAUTE, PU-PH, Principal investigator, Service de Médecine Physique et Réadaptation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745247
- Sponsor's protocol ID
- 69HCL20_0888
- Other IDs
- 2020-A03467-32
- Acronym
- FACEHAND
- Status last verified
- Feb 2021
- First submitted
- 26 Jan 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a New Form of Cross-border Plasticity Within the Somatosensory Cortex: Stimulate the Face to Improve Tactile Acuity on the Hand
- ClinicalTrials.gov ID
- NCT04745247
- Acronym / sponsor ID
- FACEHAND / 69HCL20_0888
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 21 Feb 2023 (estimated)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RSS | Experimental | Procedure: RSSRepetitive somatosensory stimulation (RSS) |
| Sham RSS | Placebo comparator | Procedure: RSSSham Repetitive somatosensory stimulation (RSS) |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSSAlso: Repetitive somatosensory stimulation (RSS), Sham Repetitive somatosensory stimulation (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 | Procedure or surgery | RSS, Sham RSS |
Primary outcome
Tactile acuity : 2 point discrimination test
Time frame: 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 : Absolute threshold detection test after 3h of RSS
Time frame: 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.
2 secondary outcomes
Jebsen-Taylor hand function test (JTHFT)
Time frame: Week 3
Questionnaire comfort/ease to use
Time frame: Week 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques LUAUTE, PU-PH principal investigator
Service de Médecine Physique et Réadaptation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RSS in people with Stroke and RSS, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacques LUAUTE, PU-PH (4 78 86 50 23 ext. +33, jacques.luaute@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tactile acuity : 2 point discrimination test (time frame: Week 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.