BIROBONIRS: fNIRS Study of Effort-dependent Brain Activations During Pointing Movements of the Upper Limb in Post-stroke Patients and Healthy Subjects

Sponsor

Clinique Les Trois Soleils (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06116006

Collaborator

Centre Hospitalier Régional d'Orléans (Other)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Upper limb paresis is the most common motor deficit following a stroke, and its long-term persistence has an impact on patients' functional recovery and quality of life. Rehabilitation is therefore a major challenge in restoring functional independence.

New physical treatments have been developed over the last 20 years to optimize motor relearning by intensifying motor rehabilitation; among them, therapy using robotic devices has shown its effectiveness in reducing motor deficits.

This therapy offers various options ranging from assistance to movement resistance, which modulates the intensity of effort required of patients during target-pointing exercises.

Our understanding of the brain mechanisms involved in this type of rehabilitation remains imperfectly understood.

Functional neuroimaging techniques such as magnetic resonance imaging (fMRI), positron emission tomography (PET) and functional near-infrared spectroscopy (fNIRS) provide important information on brain activation induced by external stimuli. Among these, fNIRS is a non-invasive method for measuring hemodynamic responses associated with activation of the cerebral cortex. It enables the study of cerebral neurovascular coupling, and is based on the fact that an activated cerebral region increases its oxygen consumption and thus local blood volume and flow.

A better understanding of the cortical effects resulting from the physical forces applied to the upper limb could help optimize the rehabilitation treatment of patients, thereby promoting cerebral plasticity.

Condition or Disease	Intervention/Treatment	Phase
Stroke Healthy	Other: Upper limb pointing movements in 3 experimental conditions	N/A

Detailed Description

The aim of the study is to compare cortical responses measured by fNIRS during 3 types of upper limb pointing movement (robot-assisted movements, robot-unassisted movements and robot-resisted movements) in patients with chronic hemiparesis after stroke and in healthy subjects.

The primary outcome is the following: variations in oxyhemoglobin and deoxyhemoglobin assessed bilaterally in the sensorimotor cortex by near-infrared spectroscopy using a multi-channel fNIRS headset (Brite MKII, Artinis). These variations will be collected during the 3 experimental conditions and during the rest phases.

Inclusion criteria:

For stroke subjects

Age ≥18 years;
Stroke-induced hemiparesis, chronic phase (>6 months post-stroke);
Moderate upper limb paresis defined by an upper limb FMA score 20 pts < FMA score< 47 pts ;
Right-handed patient;
Patient having agreed to sign an informed consent form;
Patient affiliated to the French social security system.

For healthy subjects

Age-matched participant, for each stroke subject included will be associated a control subject of the same age (to the nearest 5 years);
Right-handed participant;
Participant having agreed to sign an informed consent form;
Participant affiliated to the French social security system.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

fNIRS Study of Effort-dependent Brain Activations During Pointing Movements of the Upper Limb in Post-stroke Patients and Healthy Subjects

Anticipated Study Start Date :

Mar 1, 2024

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: Subjects with 3 experimental conditions 3 types of upper limb pointing movements: movements with robot assistance movements without robot assistance movements with robot resistance	Other: Upper limb pointing movements in 3 experimental conditions Recording of cerebral hemodynamic with fNIRS during upper limb pointing movements with a robotic device in three conditions: movements with robot assistance, movements without robot assistance and movements with robot resistance. Each subject are recorded during 6 trials for each condition (18 trials). The order is counterbalanced among the subjects.

Arm

Intervention/Treatment

Other: Subjects with 3 experimental conditions

3 types of upper limb pointing movements: movements with robot assistance movements without robot assistance movements with robot resistance

Other: Upper limb pointing movements in 3 experimental conditions

Recording of cerebral hemodynamic with fNIRS during upper limb pointing movements with a robotic device in three conditions: movements with robot assistance, movements without robot assistance and movements with robot resistance. Each subject are recorded during 6 trials for each condition (18 trials). The order is counterbalanced among the subjects.

Outcome Measures

Primary Outcome Measures

Change of oxyhemoglobin concentration during upper limb tasks [Day 0]
Change of desoxyhemoglobin concentration during upper limb tasks [Day 0]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

INCLUSION CRITERIA

For stroke subjects

Age ≥18 years;
Stroke-induced hemiparesis, chronic phase (>6 months post-stroke);
Moderate upper limb paresis defined by an upper limb FMA score 20 pts < FMA score < 47 pts ;
Right-handed patient;
Patient having agreed to sign an informed consent form;
Patient affiliated to the French social security system.

For healthy subjects

Age-matched participant, for each stroke subject included will be associated a control subject of the same age (to the nearest 5 years);
Right-handed participant;
Participant having agreed to sign an informed consent form;
Participant affiliated to the French social security system.

NON-INCLUSION CRITERIA

For stroke subjects

Cognitive impairment making participation in the study impossible;
Phasic disorders preventing comprehension of instructions and effective communication.

For healthy subjects