Investigating brain activity during upper limb movements in stroke patients and healthy individuals

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

This study is testing how different levels of effort during arm movements affect brain activity in stroke patients and healthy people to help improve recovery treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Clinique Les Trois Soleils (Academic / other)
• Locations: 1 site (Boissise-le-Roi)
• Trial ID: NCT06116006 on ClinicalTrials.gov

What this trial studies

This study aims to explore how different levels of effort during upper limb pointing movements affect brain activation in both post-stroke patients and healthy controls. Using functional near-infrared spectroscopy (fNIRS), the research will measure cortical responses while participants engage in robotic-assisted therapy with varying guidance forces. The goal is to better understand the brain mechanisms involved in motor rehabilitation, which could lead to improved treatment strategies for stroke recovery. Participants will be assessed based on their ability to perform specific movements under controlled conditions.

Who should consider this trial

Good fit: Ideal candidates include right-handed adults aged 18 and older who are in the chronic phase of stroke recovery with moderate upper limb paresis.

Not a fit: Patients with cognitive impairments or severe communication difficulties, as well as those with significant upper limb pathologies, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance rehabilitation techniques for stroke patients, leading to better motor recovery and improved quality of life.

How similar studies have performed: While there have been studies on robotic-assisted therapy for stroke rehabilitation, the specific use of fNIRS to assess brain activation during varying effort levels is a novel approach.

Eligibility criteria

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

* Pathology of the dominant upper limb;
* Cognitive disorders making participation in the study impossible;
* Presence of labelled or unlabelled neurological disorders;
* Persons under legal protection.

Where this trial is running

Boissise-le-Roi

• La Clinique Les Trois Soleils — Boissise-le-Roi, France (Recruiting)

Study contacts

• Study coordinator: Christophe Duret, Dr

Conditions Stroke; Healthy; stroke; upper limb; robot-based therapy; physical modalities; effort; fnirs