NCT05343130

Efficacy of a Brain-Computer Interface Controlled Functional Electrical Stimulation Therapy for Spinal Cord Injury Neurorehabilitation

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Instituto Nacional de Rehabilitacion · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study's main goal is to determine the efficacy of a therapy with brain-computer interface controlled functional electrical stimulation for neurorehabilitation of spinal cord injury patients' upper limbs. For this purpose, a randomized controlled trial will be performed to compare the clinical and physiological effects of the brain-computer interface therapy with those of a sham intervention comprised by the application of functional electrical stimulation independently of brain-computer interface control.

Conditions

• Cervical Spinal Cord Injury

Interventions

Type	Name	Description
DEVICE	Brain-Computer Interface	Hand movement will be elicited using functional electrical stimulation activated by the brain-computer interface based on hand movement intention.
DEVICE	Sham Brain-Computer Interface	Hand movement will be elicited using functional electrical stimulation which activation will be independent of the brain-computer interface based on hand movement intention.

Timeline

• Start date: 2022-08-01
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2022-04-25
• Last updated: 2025-06-25

Locations

1 site across 1 country: Mexico