Status:
RECRUITING
Efficacy of a Brain-Computer Interface Controlled Functional Electrical Stimulation Therapy for Spinal Cord Injury Neurorehabilitation
Lead Sponsor:
Instituto Nacional de Rehabilitacion
Collaborating Sponsors:
Instituto Tecnologico y de Estudios Superiores de Monterey
Conditions:
Cervical Spinal Cord Injury
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05343130
Start Date
August 1 2022
End Date
December 1 2027
Last Update
June 25 2025
Active Locations (1)
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1
Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra (National Institute of Rehabilitation)
Tlalpan, Mexico City, Mexico, 14389