ClinicalTrials.gg
Not yet recruitingNCT07340736HapticS 2Updated Jan 14, 2026

Sensory Mechanisms of Manual Dexterity Recovery After Stroke: a Prospective Cohort Study of Prediction and Cerebral Correlates

An interventional study of Haptic stimulation device and Brain MRI in Stroke, Upper Extremity Paresis and Manual Dexterity, sponsored by Centre Hospitalier St Anne. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-14.

Sponsored by Centre Hospitalier St Anne · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Stroke by Centre Hospitalier St Anne — 6 open to participants now, 6 under way, none of them phase 3. Stroke · Centre Hospitalier St Anne.

Planned enrollment
6th of 10
90 · median 107
Started
2026
with 1 other
No phase
10 of 12
5 open now
Registered
11th of 12
by date

Among the 12 studies in Stroke by Centre Hospitalier St Anne, this one is the 6th largest by planned enrollment of the 10 interventional ones, is one of 2 that started in 2026, is one of 10 with no phase, and was the 11th registered.

By phase

12 studies; the count open now beside each. This study's row is marked.

No phasethis study10 · 5 open
Observational2 · 1 open

By the year they started

First in 2014; this study’s year is marked. 2 started in 2026.

What they test

Size and results

Median enrollment 107 across the 10 interventional studies, 180 across the 2 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 12 studies in Stroke by Centre Hospitalier St Anne, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Stroke
  • Upper Extremity Paresis
  • Manual Dexterity
  • Sensory Integration Dysfunction
  • Vibration

Browse trials for

Keywords

  • stroke
  • haptic
  • vibration
  • sensorimotor impairment
  • manual dexterity
  • prediction of recovery
  • MRI
04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • to MRI (claustrophobia, presence of cochlear implants and/or pacemakers)
  • Persons subject to legal protection measures
  • Persons subject to judicial protection measures
  • Pregnancy
  • Life-threatening conditions or conditions requiring follow-up at 6 months
  • Epilepsy
  • Known or allergy to silicone
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Stroke patients in the early subacute phase

    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.

    Device: Haptic stimulation device · Other: Brain MRI

  • Active comparator
    Healthy controls matched in age, sex and laterality with stroke patients

    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.

    Device: Haptic stimulation device · Other: Brain MRI

Interventions

  • DeviceHaptic stimulation device

    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.

  • OtherBrain MRI

    Subjects and patients will undergo anatomical, resting-state functional, and diffusion brain MRI sequences.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months post enrollment

Secondary outcomes

  1. 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.

    Time frame: 3 and 6 months post enrollment

  2. 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.

    Time frame: 3 and 6 months post enrollment

  3. 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.

    Time frame: 3 and 6 months post enrollement

  4. 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.

    Time frame: 3 and 6 months post stroke

  5. 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.

    Time frame: 6 months post enrollement

  6. 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)

    Time frame: 3 and 6 months post stroke

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2026; primary completion for Mar 2028, 24 months later.

Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 24 months is close to that.

Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 5, 2026
First posted
Jan 14, 2026
StartEst.
Mar 1, 2026
Primary completionEst.
Mar 1, 2028
CompletionEst.
Mar 1, 2028
Last update
Jan 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07340736
Responsible party
Sponsor
First posted
Jan 14, 2026
Start date
Mar 1, 2026 (estimated)
Primary completion
Mar 1, 2028 (estimated)
Completion
Mar 1, 2028 (estimated)
Last update
Jan 14, 2026

Study contacts

Pavel Lindberg
Contact
pavel.lindberg@inserm.fr
+33140789244

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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