Efficacy of a Brain-Computer Interface Controlled Functional Electrical Stimulation Therapy for Spinal Cord Injury Neurorehabilitation
Efficacy of a Therapy With Brain-Computer Interface Controlled Functional Electrical Stimulation for Neurorehabilitation of Patients With Spinal Cord Injury (Eficacia de Una Terapia Con estimulación eléctrica Funcional Controlada Con Interfaz Cerebro-computadora Para neurorrehabilitación de Pacientes Con lesión Medular)
Instituto Nacional de Rehabilitacion
32 participants
Aug 1, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria9
- 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
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Interventions
Hand movement will be elicited using functional electrical stimulation activated by the brain-computer interface based on hand movement intention.
Hand movement will be elicited using functional electrical stimulation which activation will be independent of the brain-computer interface based on hand movement intention.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05343130