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

Not Applicable

Recruiting

• Conditions: Stroke; Healthy
• Interventions: Other: Upper limb pointing movements in 3 experimental conditions

• Registration Number: NCT06116006
• Lead Sponsor: Clinique Les Trois Soleils

Brief Summary

Background: Following a stroke, as part of neurorehabilitation, the intensity of effort is important to promote neural changes and stimulate motor recovery. There are few studies concerning the cortical activity involved at different levels of intensity during upper limb motor training.

Objective: To investigate cortex activation while walking an exoskeleton with 4 levels of guidance force in healthy controls.

Detailed Description

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.

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.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

* robot-resisted movements

in patients with chronic hemiparesis after stroke and in healthy subjects.

Study Timeline

• Study First Submitted: 2023-10-30
• Study First Submitted QC: 2023-10-30
• Study First Posted: 2023-11-03
• Status Verified: 2024-01
• Study Start: 2024-01-15
• Last Update Submitted: 2024-01-19
• Last Update Posted: 2024-01-22
• Primary Completion: 2024-11-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects with 3 experimental conditions	Upper limb pointing movements in 3 experimental conditions	3 types of upper limb pointing movements: * movements with robot assistance * movements without robot assistance * movements with robot resistance

Primary Outcome Measures

Name	Time	Method
Change of oxyhemoglobin concentration during upper limb tasks	Day 0
Change of desoxyhemoglobin concentration during upper limb tasks	Day 0

Trial Locations

Locations (1)

La Clinique Les Trois Soleils; 🇫🇷 Boissise-le-Roi, France