BCI-FES for Upper Limb Rehabilitation in Chronic Stroke

Launched by INSTITUTO NACIONAL DE REHABILITACION · May 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new therapy designed to help people recover movement in their arms after experiencing a stroke. The researchers want to see if combining traditional physical therapy with a special system called BCI-FES (which uses brain signals to assist movement) can improve arm function better than just regular physical therapy alone. Participants will be divided into two groups: one will receive only traditional physical therapy, while the other will receive both traditional therapy and the BCI-FES treatment over the course of four weeks. The goal is to help individuals regain important movements like opening their hand, grasping objects, and using utensils in everyday life.

To participate, individuals must be at least 18 years old and have had a stroke at least six months prior. They should have moderate to severe weakness on one side of their body but be able to follow instructions and complete tasks. Not everyone will be eligible; for example, those with certain neurological disorders or significant cognitive challenges cannot take part. Participants can expect to attend 20 therapy sessions over four weeks and will be assessed through various tests to measure their motor recovery and brain activity. This study is currently recruiting and aims to find new ways to support arm and hand recovery for stroke survivors.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with ischemic or hemorrhagic stroke (evidenced by CT or MRI)
• • ≥6 months from stroke onset, chronic phase
• • Unilateral lesion
• • Age ≥18 years
• • Moderate-severe hemiparesis (FMA-UE: ≤45)
• • Full passive ranges of motion in the elbow, forearm, wrist, and hand
• • Minimal cognitive level necessary to follow instructions and complete tasks
• • Desire to participate in the study
• Exclusion Criteria:
• • Neurological disorders (Parkinsons disease, epilepsy, dementia)
• • Neurological or musculoskeletal condition directly affecting the upper limb (dystonia, severe spasticity -muscle tone for elbow, wrist and fingers \> 3 according to modified Ashworth scale-)
• • Contraindications for MRI (implantable devices -pacemakers-, claustrophobia, others)
• • Cognitive deficit (MoCA \<20 points)
• • Severe aphasia
• • Severe psychiatric disorders
• • More than one stroke