RecruitingNot ApplicableNCT05343130

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)


Sponsor

Instituto Nacional de Rehabilitacion

Enrollment

32 participants

Start Date

Aug 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a brain-computer interface (BCI) system combined with functional electrical stimulation (FES) can help people with spinal cord injuries at the C6 or C7 level regain hand and arm function. The BCI reads brain signals to control the electrical stimulation that moves the muscles. You may be eligible if... - You have a spinal cord injury at the C6 or C7 neurological level - Your injury is classified as ASIA A, B, C, or D - Your arm spasticity is mild (Modified Ashworth Scale +1 or less) - Your injury occurred between 6 months and 5 years ago - You have normal or corrected-to-normal vision You may NOT be eligible if... - You have severe attention deficits - You have a history of traumatic brain injury, peripheral nerve injury, or stroke - You have been diagnosed with a neurodegenerative disease - You have had fractures in your upper limbs - You have skin lesions or contractures in your arms that restrict movement - You have excessive muscle spasms Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBrain-Computer Interface

Hand movement will be elicited using functional electrical stimulation activated by the brain-computer interface based on hand movement intention.

DEVICESham 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.


Locations(1)

Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra (National Institute of Rehabilitation)

Tlalpan, Mexico City, Mexico

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NCT05343130


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