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BCI-FES for Upper Limb Rehabilitation in Chronic Stroke

RecruitingNAAges 18 Years - anyAllInstituto Nacional de Rehabilitacion
NCT06409754 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The objective of this research is to evaluate the efficacy of an experimental therapy for motor recovery of the arm after a stroke, which includes the application of a functional electrical stimulation therapy coupled to P-300 based Brain-Computer Interface system (BCI-FES). For this purpose, the investigators will compare two groups, the first one will receive only conventional physical therapy, while the second one will receive physical conventional therapy together with BCI-FES therapy. The control and experimental group will receive 20 sessions of conventional physical therapy at a rate of five sessions per week for 4 weeks, and the experimental group will receive 20 sessions of rehabilitation with the BCI-FES system at a rate of five sessions per week for 4 weeks. Broadly speaking, the BCI is in charge of determining the movement selected by the individual and assist the hand movem

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📋 Eligibility rules (as published)
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
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What it tests

  • Functional Electrical Stimulation Therapy coupled to a P-300 based Brain-Computer Interface
  • Conventional Physical Therapy
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Where

1 site
Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra
Mexico City, Mexico
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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