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

Last updated: July 11, 2024
Sponsor: Instituto Nacional de Rehabilitacion
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Cord Injuries

Treatment

Brain-Computer Interface

Sham Brain-Computer Interface

Clinical Study ID

NCT05343130
10/22
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 AshworthScale

  • Time since disease onset of more than 6 months and less than 60 months

  • Normal or corrected to normal vision

Exclusion

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

Study Design

Total Participants: 32
Treatment Group(s): 2
Primary Treatment: Brain-Computer Interface
Phase:
Study Start date:
August 01, 2022
Estimated Completion Date:
December 31, 2025

Connect with a study center

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

    Tlalpan, Mexico City 14389
    Mexico

    Active - Recruiting

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