Sensory Mechanisms of Manual Dexterity Recovery After Stroke: a Prospective Cohort Study of Prediction and Cerebral Correlates (HapticS 2)

Centre Hospitalier St Anne

Status: Begins enrollment this month

Conditions: Upper Extremity Paresis; Stroke; Vibration; Manual Dexterity; Sensory Integration Dysfunction

Treatments: Other: Brain MRI; Device: Haptic stimulation device

Study type: Interventional

Funder types: Other

Identifiers

NCT07340736

2025-A00115-44

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Stroke patients in the early subacute phase

Experimental group

Description:

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.

Treatment:

Device: Haptic stimulation device

Other: Brain MRI

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

Active Comparator group

Description:

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.

Treatment:

Device: Haptic stimulation device

Other: Brain MRI