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

Instituto Nacional de Rehabilitacion32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Cervical Spinal Cord Injury

Interventions

Brain-Computer Interface

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Ashworth Scale * Time since disease onset of more than 6 months and less than 60 months * Normal or corrected to normal vision 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

Outcomes

Primary Outcomes

Action Research Arm Test (ARAT)

Change of upper limbs function. Scale ranges from 0 to 57 points for each upper limb. A higher score means a better upper limb function.