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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Capabilities of Upper Extremities Questionnaire (CUE-Q)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Brain-Computer Interface controlled functional electrical stimulation feedback
Intervention: Brain-Computer Interface (Device)
Sham Brain-Computer Interface controlled functional electrical stimulation feedback
Intervention: Sham Brain-Computer Interface (Device)
Outcomes
Primary Outcomes
Capabilities of Upper Extremities Questionnaire (CUE-Q)
Time Frame: At enrollment and after 7 weeks of the intervention onset
Change of the functional limitation in tetraplegia. Scale ranges from 32 to 224 points if both upper limbs are assessed. A higher score means less functional limitation outcome.
Action Research Arm Test (ARAT)
Time Frame: At enrollment and after 7 weeks of the intervention onset
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.
Upper Extremity Motor Score (UEMS)
Time Frame: At enrollment and after 7 weeks of the intervention onset
Change of upper limbs function. Scale ranges from 0 to 50 points if both upper limbs are assessed. A higher score means a better upper limb function.
Secondary Outcomes
- Spinal Cord Independence Measure III (SCIM-III)(At enrollment and after 7 weeks of the intervention onset)
- Life Satisfaction Questionnaire 9 (LISAT-9)(At enrollment and after 7 weeks of the intervention onset)
Investigators
Jessica Cantillo-Negrete
Researcher in Medical Sciences
Instituto Nacional de Rehabilitacion