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

Instituto Nacional de Rehabilitacion

Status: Enrolling

Conditions: Cervical Spinal Cord Injury

Treatments: Device: Brain-Computer Interface; Device: Sham Brain-Computer Interface

Study type: Interventional

Funder types: Other

Identifiers

NCT05343130

10/22

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

32 participants in 2 patient groups

Brain-Computer Interface controlled functional electrical stimulation feedback

Experimental group

Treatment:

Device: Brain-Computer Interface

Sham Brain-Computer Interface controlled functional electrical stimulation feedback

Sham Comparator group

Treatment:

Device: Sham Brain-Computer Interface