Using Brain-Computer Interfaces for Arm Rehabilitation After Stroke
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto Nacional de Rehabilitacion Government |
| Locations | 1 site (Mexico City, Mexico City) |
| Trial ID | NCT06409754 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with other neurological disorders, severe cognitive deficits, or those who have had multiple strokes may not benefit from this study.
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 performed: Previous studies have shown promise in using brain-computer interfaces for rehabilitation, indicating potential for success in this novel approach.
Eligibility criteria
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 this trial is running
Mexico City, Mexico City
- Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra — Mexico City, Mexico City, Mexico (Recruiting)
Study contacts
- Study coordinator: Jimena Quinzaños Fresnedo, MD, PhD
- Email: jquinzanos@inr.gob.mx
- Phone: +52 5559991000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.