Using brain-computer interface to help rehabilitate upper limbs in spinal cord injury patients
Efficacy of a Therapy With Brain-Computer Interface Controlled Functional Electrical Stimulation for Neurorehabilitation of Patients With Spinal Cord Injury (Eficacia de Una Terapia Con estimulación eléctrica Funcional Controlada Con Interfaz Cerebro-computadora Para neurorrehabilitación de Pacientes Con lesión Medular)
This study tests whether a brain-computer interface can help people with spinal cord injuries regain movement in their arms better than a standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto Nacional de Rehabilitacion Government |
| Locations | 1 site (Tlalpan, Mexico City) |
| Trial ID | NCT05343130 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a brain-computer interface (BCI) controlled functional electrical stimulation therapy for neurorehabilitation in patients with cervical spinal cord injuries. It will involve a randomized controlled trial comparing the outcomes of BCI therapy against a sham intervention that applies functional electrical stimulation without BCI control. The primary focus is on improving motor function in the upper limbs of participants with varying degrees of spinal cord injury. The study will assess both clinical and physiological effects to determine the therapy's efficacy.
Who should consider this trial
Good fit: Ideal candidates are individuals with cervical spinal cord injuries at neurological levels C6 or C7, classified as ASIA A, B, C, or D, and who have upper limb spasticity of +1 or less.
Not a fit: Patients with severe attention deficits, previous traumatic brain injuries, or other neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly enhance motor rehabilitation outcomes for patients with spinal cord injuries.
How similar studies have performed: Other studies have shown promise in using brain-computer interfaces for rehabilitation, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Spinal Cord Injury at neurological levels C6 or C7 * American Spinal Injury Association (ASIA) classification A, B, C or D * Upper limb spasticity of less or equal to +1 measured with the Modified Ashworth Scale * Time since disease onset of more than 6 months and less than 60 months * Normal or corrected to normal vision Exclusion Criteria: * Severe attention deficits * Previous diagnosis of traumatic brain injury * Previous diagnosis of peripheral nerve injury * Previous stroke diagnosis * Previous diagnosis of neurodegenerative diseases * History of fractures in upper extremities * Skin lesions * Contractures in upper extremities that hamper mobility * Excessive muscle spasms
Where this trial is running
Tlalpan, Mexico City
- Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra (National Institute of Rehabilitation) — Tlalpan, Mexico City, Mexico (Recruiting)
Study contacts
- Principal investigator: Jessica Cantillo-Negrete, PhD — Instituto Nacional de Rehabilitacion (National Institute of Rehabilitation)
- Study coordinator: Jessica Cantillo-Negrete, PhD
- Email: jcantillo@inr.gob.mx
- Phone: +525559991000
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.