Efficacy of a Brain-Computer Interface Controlled Functional Electrical Stimulation Therapy for Spinal Cord Injury Neurorehabilitation

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Cervical Spinal Cord Injury

Intervention / Treatment
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* Device: Brain-Computer Interface
* Device: Sham Brain-Computer Interface


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brain-Computer Interface controlled functional electrical stimulation feedback<br> | Device: Brain-Computer Interface<br>* Hand movement will be elicited using functional electrical stimulation activated by the brain-computer interface based on hand movement intention.<br>|
| Sham Comparator: Sham Brain-Computer Interface controlled functional electrical stimulation feedback<br> | Device: Sham Brain-Computer Interface<br>* Hand movement will be elicited using functional electrical stimulation which activation will be independent of the brain-computer interface based on hand movement intention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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functional electrical stimulation, motor rehabilitation, tetraplegia, brain-computer interface