NCT05343130 Efficacy of a Brain-Computer Interface Controlled Functional Electrical Stimulation Therapy for Spinal Cord Injury Neurorehabilitation
| NCT ID | NCT05343130 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto Nacional de Rehabilitacion |
| Condition | Cervical Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2022-08-01 |
| Primary Completion | 2027-06 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 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