Sensory Mechanisms of Manual Dexterity Recovery After Stroke: a Prospective Cohort Study of Prediction and Cerebral Correlates
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Haptic stimulation device, Brain MRI.
- Who it may be relevant to
- Registry conditions: Stroke, Upper Extremity Paresis, Manual Dexterity, Sensory Integration Dysfunction. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Haptic 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. - Other Brain MRI
Subjects and patients will undergo anatomical, resting-state functional, and diffusion brain MRI sequences.
Primary outcome measures
- Gain in the prediction of manual dexterity recovery [Time frame: 3 months post enrollment]
Secondary outcome measures (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. [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]
Eligibility criteria
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
- 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
- Life-threatening conditions or conditions requiring follow-up at 6 months
- Epilepsy
- Known hypersensitivity or allergy to silicone
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- GHU Psychiatrie et Neurosciences — Paris
Identifiers
NCT: NCT07340736 · 2025-A00115-44