Efficacy of a Brain-Computer Interface Controlled Functional Electrical Stimulation Therapy for Spinal Cord Injury Neurorehabilitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brain-Computer Interface, Sham Brain-Computer Interface.
- Who it may be relevant to
- Registry conditions: Cervical Spinal Cord Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mexico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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
- Device Brain-Computer Interface
Hand movement will be elicited using functional electrical stimulation activated by the brain-computer interface based on hand movement intention. - Device Sham Brain-Computer Interface
Hand movement will be elicited using functional electrical stimulation which activation will be independent of the brain-computer interface based on hand movement intention.
Primary outcome measures
- Action Research Arm Test (ARAT) [Time frame: At enrollment and after 7 weeks of the intervention onset]
- Upper Extremity Motor Score (UEMS) [Time frame: At enrollment and after 7 weeks of the intervention onset]
- Capabilities of Upper Extremities Questionnaire (CUE-Q) [Time frame: At enrollment and after 7 weeks of the intervention onset]
Secondary outcome measures (2)
- Spinal Cord Independence Measure III (SCIM-III) [Time frame: At enrollment and after 7 weeks of the intervention onset]
- Life Satisfaction Questionnaire 9 (LISAT-9) [Time frame: At enrollment and after 7 weeks of the intervention onset]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Mexico · 1 center
- Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra (National Institute of R — Tlalpan
Identifiers
NCT: NCT05343130 · 10/22