NCT04724824

Validation of a Brain-Computer Interface for Stroke Neurological Upper Limb Rehabilitation

Validation of a Brain-Computer Interface for Neurorehabilitation With a Randomized Controlled Trial (Validación de Una Interfaz Cerebro-Computadora Para Rehabilitación Neurológica Por Medio de un Ensayo Clínico Controlado y Aleatorizado)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• 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 if clinical and physiological effects of a brain-computer interface intervention for the neurorehabilitation of stroke patients' upper limb are greater than the effects of a sham robotic feedback. For this purpose a randomized controlled trial will be performed to compare somatosensory sham robotic feedback with the same somatosensory feedback controlled with the brain-computer interface output.

Conditions

• Stroke, Ischemic
• Stroke

Interventions

Type	Name	Description
DEVICE	Brain-Computer Interface	Passive hand movement will be provided to patients' paralyzed hand by means of a robotic hand orthosis that will be activated by the brain-computer interface based on hand movement intention.
DEVICE	Sham Brain-Computer Interface	Passive hand movement will be provided to patients' paralyzed hand by means of a robotic hand orthosis which activation will be independent of the output of the brain-computer interface based on hand movement intention.

Timeline

• Start date: 2021-03-16
• Primary completion: 2024-06-24
• Completion: 2024-06-24
• First posted: 2021-01-26
• Last updated: 2024-07-12

Locations

1 site across 1 country: Mexico