Post-stroke Sensory Deficits at the HandHAND-HANDNCT06149325
Stimulate One Hand to Improve Tactile Perception on the Other
A study testing Repetitive somatosensory stimulation (RSS) in people with Post-stroke Sensory Deficits at the Hand, 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 one hand compared to the administration of strategy Sham stimulation, results in an temporary improvement in the tactile acuity of the other 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
- Conditions the study is for
- Post-stroke Sensory Deficits at the Hand
- What is being tested?
- Repetitive somatosensory stimulation (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
- 30 Apr 2024to 30 May 2026
- 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 hemorrhagic stroke
- Stroke event dates at least 3 months before the date of inclusion to the study
- Severe-to-mild 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
Show all 19Show fewer
- 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
- History of neurological or psychiatric illness
- 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
- Persons in psychiatric care
- Congenital or acquired malformation/injury of the test fingers
- Impossibility to maintain hand position necessary for the tests due to severe spasticity
Who cannot join
- Severe impairment of the sensibility of the index finger of the spared hand preventing the administration of the RSS
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Groupement Hospitalier du Sud - Hôpital Henry Gabrielle
Saint-Genis-Laval, 69230
Jacques LUAUTE, Pr, 4 78 86 50 23 ext. +33, jacques.luaute@chu-lyon.fr
About this study
The study is a comparative study, to show that the administration of RSS stimulation on one hand compared to the administration of strategy Sham stimulation, results in an temporary improvement in the tactile acuity of the other hand in patients with tactile acuity impairment of the hand due to stroke.
- Conditions
- Post-stroke Sensory Deficits at the Hand
- Being tested
- Repetitive somatosensory stimulation (RSS), Sham Repetitive somatosensory stimulation (RSS)
- Keywords
- Stroke, Sensory deficits, RSS
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive somatosensory stimulation (RSS)Procedure or surgery
Tactile stimuli on the index finger of the intact hand, for a duration of 45 minutes
Sham Repetitive somatosensory stimulation (RSS)Procedure or surgery
Tactile stimuli on the index finger of the intact hand, for a duration of 4 minutes spread over 45 minutes in 6 blocks of 40 seconds
| Study group | Role | What they receive |
|---|---|---|
| Repetitive somatosensory stimulation (RSS), then SHAM | Experimental | Adult patients suffering from post-stroke sensory deficits at the hand. Each participant will participate to the study on two different days, at least a week apart from each other. The length of the experimental session on these two days will be the same: 2 hours in the morning, to perform Pre-evaluation of the tactile acuity, absolute detection, overall hand functionality and manual dexterity, and 3 hours in the afternoon, including 45 minutes of stimulation (RSS or Sham) and 2 hours of Post-evaluation of the tactile acuity, absolute detection, overall hand functionality and manual dexterity. In total, the length of the participation of each patient will be of 10 hours, spread on two days. Receives: Procedure: Repetitive somatosensory stimulation (RSS); Procedure: Sham Repetitive somatosensory stimulation (RSS) |
| Sham Repetitive somatosensory stimulation (RSS), then RSS | Experimental | Adult patients suffering from post-stroke sensory deficits at the hand. Each participant will participate to the study on two different days, at least a week apart from each other. The length of the experimental session on these two days will be the same: 2 hours in the morning, to perform Pre-evaluation of the tactile acuity, absolute detection, overall hand functionality and manual dexterity, and 3 hours in the afternoon, including 45 minutes of stimulation (RSS or Sham) and 2 hours of Post-evaluation of the tactile acuity, absolute detection, overall hand functionality and manual dexterity. In total, the length of the participation of each patient will be of 10 hours, spread on two days. Receives: Procedure: Repetitive somatosensory stimulation (RSS); Procedure: Sham Repetitive somatosensory stimulation (RSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tactile acuity : composite of 2point discrimination test (2PDT) and Absolute threshold detection test after 45minutes of RSS
To show that RSS applied for 45 minutes on the index finger of the spared hand in stroke patients suffering from sensory deficits improves their tactile sensitivity on the affected (unstimulated) hand, measured in terms of improved spatial discrimination and/or improved absolute detection.
Measured: Immediate after the 45 minutes of RSS
Secondary outcomes (2)
Jebsen-Taylor hand function test (JTHFT)
Overall functionality of the hand, especially with regard to handling objects
Measured: Immediate after the 45 minutes of RSS
Manual dexterity Pegboard test
Assessment of manual dexterity of the affected unstimulated hand (as well as of the spared hand)
Measured: Immediate after the 45 minutes of RSS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start30 Apr 2024
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke Sensory Deficits at the HandStudies 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
- Model description
- The study is a comparative study, to show that the administration of RSS stimulation leads to a better performance compared to the administration of Sham stimulation (control). The participant's performance after receiving Sham stimulation will be unchanged compared to the baseline performance measured before the stimulation. On the contrary, participant's performance after receiving RSS stimulation will show a considerable improvement compared to the baseline performance, proving the superiority of RSS stimulation over the control. The study has a cross-over design, where each participant receives both stimulations, on different days. The two stimulations will be administered in a randomized order across participants, and in double-blind.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149325
- Sponsor's protocol ID
- 69HCL23_0913
- Other IDs
- 2023-A01994-41
- Acronym
- HAND-HAND
- Status last verified
- May 2024
- First submitted
- 20 Nov 2023
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulate One Hand to Improve Tactile Perception on the Other
- ClinicalTrials.gov ID
- NCT06149325
- Acronym / sponsor ID
- HAND-HAND / 69HCL23_0913
- Conditions
- Post-stroke Sensory Deficits at the Hand
- Keywords
- Stroke, Sensory deficits, RSS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 29 Nov 2023 (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 one hand compared to the administration of strategy Sham stimulation, results in an temporary improvement in the tactile acuity of the other 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
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study is a comparative study, to show that the administration of RSS stimulation leads to a better performance compared to the administration of Sham stimulation (control). The participant's performance after receiving Sham stimulation will be unchanged compared to the baseline performance measured before the stimulation. On the contrary, participant's performance after receiving RSS stimulation will show a considerable improvement compared to the baseline performance, proving the superiority of RSS stimulation over the control. The study has a cross-over design, where each participant receives both stimulations, on different days. The two stimulations will be administered in a randomized order across participants, and in double-blind.
| Arm | Type | Receives |
|---|---|---|
| Repetitive somatosensory stimulation (RSS), then SHAM | Experimental | Procedure: Repetitive somatosensory stimulation (RSS), Procedure: Sham Repetitive somatosensory stimulation (RSS)Adult patients suffering from post-stroke sensory deficits at the hand. Each participant will participate to the study on two different days, at least a week apart from each other. The length of the experimental session on these two days will be the same: 2 hours in the morning, to perform Pre-evaluation of the tactile acuity, absolute detection, overall hand functionality and manual dexterity, and 3 hours in the afternoon, including 45 minutes of stimulation (RSS or Sham) and 2 hours of Post-evaluation of the tactile acuity, absolute detection, overall hand functionality and manual dexterity. In total, the length of the participation of each patient will be of 10 hours, spread on two days. |
| Sham Repetitive somatosensory stimulation (RSS), then RSS | Experimental | Procedure: Repetitive somatosensory stimulation (RSS), Procedure: Sham Repetitive somatosensory stimulation (RSS)Adult patients suffering from post-stroke sensory deficits at the hand. Each participant will participate to the study on two different days, at least a week apart from each other. The length of the experimental session on these two days will be the same: 2 hours in the morning, to perform Pre-evaluation of the tactile acuity, absolute detection, overall hand functionality and manual dexterity, and 3 hours in the afternoon, including 45 minutes of stimulation (RSS or Sham) and 2 hours of Post-evaluation of the tactile acuity, absolute detection, overall hand functionality and manual dexterity. In total, the length of the participation of each patient will be of 10 hours, spread on two days. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Non inclusion Criteria * :
Key exclusion criteria (1 listed)
- Severe impairment of the sensibility of the index finger of the spared hand preventing the administration of the RSS
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 |
|---|---|---|
| Repetitive somatosensory stimulation (RSS)Tactile stimuli on the index finger of the intact hand, for a duration of 45 minutes | Procedure or surgery | Repetitive somatosensory stimulation (RSS), then SHAM, Sham Repetitive somatosensory stimulation (RSS), then RSS |
| Sham Repetitive somatosensory stimulation (RSS)Tactile stimuli on the index finger of the intact hand, for a duration of 4 minutes spread over 45 minutes in 6 blocks of 40 seconds | Procedure or surgery | Repetitive somatosensory stimulation (RSS), then SHAM, Sham Repetitive somatosensory stimulation (RSS), then RSS |
Primary outcome
Tactile acuity : composite of 2point discrimination test (2PDT) and Absolute threshold detection test after 45minutes of RSS
Time frame: Immediate after the 45 minutes of RSS
To show that RSS applied for 45 minutes on the index finger of the spared hand in stroke patients suffering from sensory deficits improves their tactile sensitivity on the affected (unstimulated) hand, measured in terms of improved spatial discrimination and/or improved absolute detection.
2 secondary outcomes
Jebsen-Taylor hand function test (JTHFT)
Time frame: Immediate after the 45 minutes of RSS
Manual dexterity Pegboard test
Time frame: Immediate after the 45 minutes of RSS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive somatosensory stimulation (RSS) in people with Post-stroke Sensory Deficits at the Hand, 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 19 inclusion and 1 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 17 May 2024. 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. 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, Pr (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 : composite of 2point discrimination test (2PDT) and Absolute threshold detection test after 45minutes of RSS (time frame: Immediate after the 45 minutes of RSS). 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 17 May 2024.