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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto Nacional de Rehabilitacion

About this trial

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

Qualifiers

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 Ashworth Scale

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

Disqualifiers

Severe attention deficits

Previous diagnosis of traumatic brain injury

Previous diagnosis of peripheral nerve injury

Previous stroke diagnosis

Trial design

Treatments tested in this trial

  • Brain-Computer Interface
  • Sham Brain-Computer Interface

Treatment groups

32 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Instituto Nacional de Rehabilitacion

Lead sponsor

Instituto Tecnologico y de Estudios Superiores de Monterey

Collaborator