Cervical Spinal Cord Injury
Conditions
Keywords
brain-computer interface, functional electrical stimulation, motor rehabilitation, tetraplegia
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.
Interventions
DEVICEBrain-Computer Interface
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.
Sponsors
Instituto Tecnologico y de Estudios Superiores de Monterey
Instituto Nacional de Rehabilitacion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Action Research Arm Test (ARAT) | 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) | 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. |
| Capabilities of Upper Extremities Questionnaire (CUE-Q) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spinal Cord Independence Measure III (SCIM-III) | At enrollment and after 7 weeks of the intervention onset | Change of achievements of daily function. Scale ranges from 0 to 100 points. A higher score means a better capacity to perform activities of the daily living. |
| Life Satisfaction Questionnaire 9 (LISAT-9) | At enrollment and after 7 weeks of the intervention onset | Change of life satisfaction. Scale ranges from 0 to 54 points. A higher score is expected with a better life satisfaction. |
Countries
Mexico
Contacts
Primary ContactJessica Cantillo-Negrete, PhD
Backup ContactRuben I Carino-Escobar, PhD
Outcome results
None listed