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| Name | Class |
|---|---|
| Instituto Tecnologico y de Estudios Superiores de Monterey | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brain-Computer Interface controlled functional electrical stimulation feedback | Experimental |
| |
| Sham Brain-Computer Interface controlled functional electrical stimulation feedback | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain-Computer Interface | Device | Hand movement will be elicited using functional electrical stimulation activated by the brain-computer interface based on hand movement intention. |
| Measure | Description | Time Frame |
|---|---|---|
| Action Research Arm Test (ARAT) | 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. | At enrollment and after 7 weeks of the intervention onset |
| Upper Extremity Motor Score (UEMS) | 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. | At enrollment and after 7 weeks of the intervention onset |
| Capabilities of Upper Extremities Questionnaire (CUE-Q) | 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. | At enrollment and after 7 weeks of the intervention onset |
| Measure | Description | Time Frame |
|---|---|---|
| Spinal Cord Independence Measure III (SCIM-III) | 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. | At enrollment and after 7 weeks of the intervention onset |
| Life Satisfaction Questionnaire 9 (LISAT-9) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Cantillo-Negrete, PhD | Contact | +525559991000 | 19008 | jcantillo@inr.gob.mx |
| Ruben I Carino-Escobar, PhD | Contact | +525559991000 | 19008 | ricarino@inr.gob.mx |
| Name | Affiliation | Role |
|---|---|---|
| Jessica Cantillo-Negrete, PhD | Instituto Nacional de Rehabilitacion (National Institute of Rehabilitation) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra (National Institute of Rehabilitation) | Recruiting | Tlalpan | Mexico City | 14389 | Mexico |
De-identified individual participant data collected during the study will be available to other researchers from the principal investigator on reasonable request
Six months after publication
Researchers that make a request for access data and their request is approved by the National Institute of Rehabilitation Ethics Committee
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| Sham Brain-Computer Interface | Device | Hand movement will be elicited using functional electrical stimulation which activation will be independent of the brain-computer interface based on hand movement intention. |
|
Change of life satisfaction. Scale ranges from 0 to 54 points. A higher score is expected with a better life satisfaction. |
| At enrollment and after 7 weeks of the intervention onset |
| ID | Term |
|---|---|
| D011782 | Quadriplegia |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D062207 | Brain-Computer Interfaces |
| ID | Term |
|---|---|
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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