Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Using Brain-Computer Interfaces for Arm Rehabilitation After Stroke

Official title: Application of Functional Electrical Stimulation Therapy Coupled to a P300-based Brain-Computer Interface for Paretic Upper Limb Rehabilitation in Chronic Stroke: A Randomized Controlled Trial

Run by Instituto Nacional de Rehabilitacion · NCT06409754 · Data updated 2026-11-12

This study is testing a new therapy that uses a brain-computer interface to help stroke survivors improve their arm movement during rehabilitation.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment26 (estimated)
SponsorInstituto Nacional de Rehabilitacion
Government
Locations1 site (Mexico City, Mexico City)
StatusRecruiting
StartedAugust 6, 2024
Main results expectedJuly 2025
Study endsJune 2026
Registry record updatedFebruary 27, 2025
Trial IDNCT06409754 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older who have experienced a stroke at least six months prior and have moderate to severe upper limb paralysis.

Probably not a fit

Patients with other neurological disorders, severe cognitive deficits, or those who have had multiple strokes may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research evaluates the effectiveness of a new therapy combining functional electrical stimulation with a Brain-Computer Interface (BCI) for improving arm movement in patients recovering from a stroke. Participants will be divided into two groups: one receiving standard physical therapy and the other receiving both standard therapy and the BCI-FES intervention. The BCI system interprets the user's intentions to assist in executing hand movements during rehabilitation sessions. The study aims to determine if this innovative approach can enhance motor recovery compared to conventional methods alone.

Why it matters

Potential benefit: If successful, this therapy could significantly improve motor recovery and daily functioning for stroke survivors with upper limb paralysis.

How similar studies have gone: Previous studies have shown promise in using brain-computer interfaces for rehabilitation, indicating potential for success in this novel approach.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra
    Mexico City, Mexico City, Mexico
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.