StrokeHapticS 2NCT07340736
Sensory Mechanisms of Manual Dexterity Recovery After Stroke: a Prospective Cohort Study of Prediction and Cerebral Correlates
A study testing Haptic stimulation device and Brain MRI in people with Stroke and Upper Extremity Paresis, run by Centre Hospitalier St Anne at 1 site in France.
Trial summary
In the proposed research, we will assess motor and sensory functions of the hand using clinical tests and a tool designed to measure manual dexterity combined with vibrotactile stimulation. We will also evaluate the integrity of brain structure and function using MRI. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Upper Extremity Paresis, Manual Dexterity
- What is being tested?
- Haptic stimulation device and Brain MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2026to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First symptomatic stroke, ischaemic or haemorrhagic in the early subacute phase (up to 3 weeks post-stroke)
- Upper limb paresis (≤4/5 MRC Scale)
- Ability to grasp, lift and put down 1 block (from the BBT test)
- Be affiliated to a social security
Who cannot join
- Presence of another neurological or musculoskeletal condition affecting upper limb movement
- Severe cognitive impairment and/or aphasia with inability to understand and carry out instructions
- Contraindications to MRI (claustrophobia, presence of cochlear implants and/or pacemakers)
- Persons subject to legal protection measures
- Persons subject to judicial protection measures
- Pregnancy
Show all 9Show fewer
- Life-threatening conditions or conditions requiring follow-up at 6 months
- Epilepsy
- Known hypersensitivity or allergy to silicone
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
GHU Psychiatrie et Neurosciences
Paris, 75014
Sabrina Lekcir, sabrina.lekcir@ghu-paris.fr
About this study
In the proposed research, we will assess motor and sensory functions of the hand using clinical tests and a tool designed to measure manual dexterity combined with vibrotactile stimulation. We will also evaluate the integrity of brain structure and function using MRI.
Read the detailed description
In this study, 90 post-stroke patients will be followed over three visits at 3 weeks, 3 months, and 6 months after stroke. Manual dexterity will be assessed using the Dextrain Manipulandum, both with and without the addition of finger vibrations. These vibrations will be delivered using vibratory rings, a tool that has been developed and is currently being validated in healthy participants and in patients with chronic post-stroke conditions. These measurements will allow us to quantify haptic facilitation, that is the impact of adding finger vibrations on hand motor function.
During each of the three visits, we will also administer validated sensory, motor, and cognitive clinical assessments, as well as anatomical, resting-state functional, and diffusion MRI sequences to investigate brain structure and function in relation to this haptic facilitation. These longitudinal measurements will enable the development of biomarkers of motor recovery of manual dexterity after stroke, with the primary objective of improving the prediction of dexterity recovery using a regression model.
- Conditions
- Stroke, Upper Extremity Paresis, Manual Dexterity, Sensory Integration Dysfunction, Vibration
- Being tested
- Haptic stimulation device, Brain MRI
- Keywords
- stroke, haptic, vibration, sensorimotor impairment, manual dexterity, prediction of recovery, MRI
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haptic stimulation deviceDevice
Both patients and healthy participants will perform manual dexterity tasks using the Dextrain Manipulandum. In addition, they will receive finger vibrations delivered via rings that we have previously developed. These vibrations will have a frequency of 150 Hz and will be delivered for a duration of 150 ms.
Brain MRIOther
Subjects and patients will undergo anatomical, resting-state functional, and diffusion brain MRI sequences.
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients in the early subacute phase | Experimental | Patients will be followed for 6 months over three visits. They will undergo validated sensory, motor, and cognitive clinical assessments, as well as MRI scans and manual dexterity tests performed with and without the addition of vibratory stimulation to the fingers, using a tool previously developed as part of this project. Receives: Device: Haptic stimulation device; Other: Brain MRI |
| Healthy controls matched in age, sex and laterality with stroke patients | Active comparator | Healthy control participants will be assessed during a single visit. They will undergo motor, sensory, and cognitive clinical assessments, as well as manual dexterity tasks performed with and without the addition of finger vibrations using a previously developed tool. They will also undergo anatomical, resting-state functional, and diffusion brain MRI sequences. Each healthy participant will be matched to a patient in terms of age, sex, and handedness of the affected limb. For example, if we include a 60-year-old male post-stroke patient who is right-handed and has a right upper-limb impairment, we will include a healthy male participant aged 60 ± 5 years who is also right-handed. Receives: Device: Haptic stimulation device; Other: Brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gain in the prediction of manual dexterity recovery
The primary outcome measure is a 10% improvement in the prediction of the Box and Block Test (BBT) score at 3 and 6 months post-stroke achieved by adding the haptic effect to a multivariate model.
Measured: 3 months post enrollment
Secondary outcomes (6)
Change in the prediction of the Box and Block Test (BBT) score when taking into account the haptic effect during an index finger force control task.
Determine whether the haptic effect calculated during an index finger force control exercise (using the dextrain manipulandum) measured in the acute phase after stroke can improve the prediction of manual dexterity recovery (Box and Blocks Test, BBT) at 3 months and 6 months after stroke.
Measured: 3 and 6 months post enrollment
Predicting recovery in various clinical tests of motor and sensory function and activity limitations at 3 months and 6 months post-stroke.
Determine whether the haptic effect VS absence of haptic effect improves the prediction of recovery from motor impairment (Fugl Mayer Assessment for Upper Extremity FMA-UE, Purdue Pegboard Test), sensitivity (monofilaments and Nottingham Sensory Assessment), and activity limitations (Stroke Impact Scale) of the upper limb from 3 weeks to 3 and 6 months post-stroke.
Measured: 3 and 6 months post enrollment
Difference in functional and structural connectivity between subgroups with vs without haptic effect at 3 and 6 months
Investigate whether connectivity of fronto-parietal networks at 3 weeks post-stroke predicts recovery of haptic effect and dexterity at 3 and 6 months.
Measured: 3 and 6 months post enrollement
Changes in the structural and functional connectivity of fronto-parietal networks between 3 weeks and 6 months post-stroke
A difference in the change in connectivity between subgroups with versus without haptic effect at 6 months will be investigated.
Measured: 3 and 6 months post stroke
Difference in brain connectivity between brain images of healthy subjects and patients 3 weeks post-stroke and healthy subjects and patients 6 months post-stroke.
Compare brain connectivity between the group of healthy subjects and the group of patients at 3 weeks and 6 months post-stroke.
Measured: 6 months post enrollement
Correlation between the location of the lesion at 3 weeks and the haptic effect and the results of clinical tests
These correlations will be done using Voxel Based Lesion Symptoms Mapping technique (VLSM)
Measured: 3 and 6 months post stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (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 Centre Hospitalier St AnneThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340736
- Sponsor's protocol ID
- 2025-A00115-44
- Acronym
- HapticS 2
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Mechanisms of Manual Dexterity Recovery After Stroke: a Prospective Cohort Study of Prediction and Cerebral Correlates
- ClinicalTrials.gov ID
- NCT07340736
- Acronym / sponsor ID
- HapticS 2 / 2025-A00115-44
- Conditions
- Stroke, Upper Extremity Paresis, Manual Dexterity, Sensory Integration Dysfunction, Vibration
- Keywords
- stroke, haptic, vibration, sensorimotor impairment, manual dexterity, prediction of recovery, MRI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 14 Jan 2026 (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.
In the proposed research, we will assess motor and sensory functions of the hand using clinical tests and a tool designed to measure manual dexterity combined with vibrotactile stimulation. We will also evaluate the integrity of brain structure and function using MRI.
Detailed description
In this study, 90 post-stroke patients will be followed over three visits at 3 weeks, 3 months, and 6 months after stroke. Manual dexterity will be assessed using the Dextrain Manipulandum, both with and without the addition of finger vibrations. These vibrations will be delivered using vibratory rings, a tool that has been developed and is currently being validated in healthy participants and in patients with chronic post-stroke conditions. These measurements will allow us to quantify haptic facilitation, that is the impact of adding finger vibrations on hand motor function.
During each of the three visits, we will also administer validated sensory, motor, and cognitive clinical assessments, as well as anatomical, resting-state functional, and diffusion MRI sequences to investigate brain structure and function in relation to this haptic facilitation. These longitudinal measurements will enable the development of biomarkers of motor recovery of manual dexterity after stroke, with the primary objective of improving the prediction of dexterity recovery using a regression model.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke patients in the early subacute phase | Experimental | Device: Haptic stimulation device, Other: Brain MRIPatients will be followed for 6 months over three visits. They will undergo validated sensory, motor, and cognitive clinical assessments, as well as MRI scans and manual dexterity tests performed with and without the addition of vibratory stimulation to the fingers, using a tool previously developed as part of this project. |
| Healthy controls matched in age, sex and laterality with stroke patients | Active comparator | Device: Haptic stimulation device, Other: Brain MRIHealthy control participants will be assessed during a single visit. They will undergo motor, sensory, and cognitive clinical assessments, as well as manual dexterity tasks performed with and without the addition of finger vibrations using a previously developed tool. They will also undergo anatomical, resting-state functional, and diffusion brain MRI sequences. Each healthy participant will be matched to a patient in terms of age, sex, and handedness of the affected limb. For example, if we include a 60-year-old male post-stroke patient who is right-handed and has a right upper-limb impairment, we will include a healthy male participant aged 60 ± 5 years who is also right-handed. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First symptomatic stroke, ischaemic or haemorrhagic in the early subacute phase (up to 3 weeks post-stroke)
- Upper limb paresis (≤4/5 MRC Scale)
- Ability to grasp, lift and put down 1 block (from the BBT test)
- Be affiliated to a social security
Key exclusion criteria (9 listed)
- Presence of another neurological or musculoskeletal condition affecting upper limb movement
- Severe cognitive impairment and/or aphasia with inability to understand and carry out instructions
- Contraindications to MRI (claustrophobia, presence of cochlear implants and/or pacemakers)
- Persons subject to legal protection measures
- Persons subject to judicial protection measures
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 |
|---|---|---|
| Haptic stimulation deviceBoth patients and healthy participants will perform manual dexterity tasks using the Dextrain Manipulandum. In addition, they will receive finger vibrations delivered via rings that we have previously developed. These vibrations will have a frequency of 150 Hz and will be delivered for a duration of 150 ms. | Device | Healthy controls matched in age, sex and laterality with stroke patients, Stroke patients in the early subacute phase |
| Brain MRISubjects and patients will undergo anatomical, resting-state functional, and diffusion brain MRI sequences. | Other | Healthy controls matched in age, sex and laterality with stroke patients, Stroke patients in the early subacute phase |
Primary outcome
Gain in the prediction of manual dexterity recovery
Time frame: 3 months post enrollment
The primary outcome measure is a 10% improvement in the prediction of the Box and Block Test (BBT) score at 3 and 6 months post-stroke achieved by adding the haptic effect to a multivariate model.
6 secondary outcomes
Change in the prediction of the Box and Block Test (BBT) score when taking into account the haptic effect during an index finger force control task.
Time frame: 3 and 6 months post enrollment
Predicting recovery in various clinical tests of motor and sensory function and activity limitations at 3 months and 6 months post-stroke.
Time frame: 3 and 6 months post enrollment
Difference in functional and structural connectivity between subgroups with vs without haptic effect at 3 and 6 months
Time frame: 3 and 6 months post enrollement
Changes in the structural and functional connectivity of fronto-parietal networks between 3 weeks and 6 months post-stroke
Time frame: 3 and 6 months post stroke
Difference in brain connectivity between brain images of healthy subjects and patients 3 weeks post-stroke and healthy subjects and patients 6 months post-stroke.
Time frame: 6 months post enrollement
Correlation between the location of the lesion at 3 weeks and the haptic effect and the results of clinical tests
Time frame: 3 and 6 months post stroke
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Haptic stimulation device and Brain MRI in people with Stroke and Upper Extremity Paresis, run by Centre Hospitalier St Anne 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 4 inclusion and 9 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: opening soon, as of the sponsor's last update on 14 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pavel Lindberg (+33140789244, pavel.lindberg@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gain in the prediction of manual dexterity recovery (time frame: 3 months post enrollment). 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 14 Jan 2026.