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

NCT05343130 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-06-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Instituto Tecnologico y de Estudios Superiores de Monterey

    collaborator OTHER
  • Instituto Nacional de Rehabilitacion

    lead OTHER_GOV

Principal Investigators

  • Jessica Cantillo-Negrete, PhD · Instituto Nacional de Rehabilitacion (National Institute of Rehabilitation)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2027-06-30
Completion
2027-12-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05343130 on ClinicalTrials.gov