Actively Recruiting
Efficacy of a Therapy With Brain-Computer Interface Controlled Functional Electrical Stimulation for Neurorehabilitation of Patients With Spinal Cord Injury
Led by Instituto Nacional de Rehabilitacion · Updated on 2025-06-25
32
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
I
Instituto Nacional de Rehabilitacion
Lead Sponsor
I
Instituto Tecnologico y de Estudios Superiores de Monterey
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a therapy that uses a brain-computer interface combined with functional electrical stimulation to help improve upper limb function in people with cervical spinal cord injury. This randomized controlled trial compares this brain-controlled therapy with a sham intervention where electrical stimulation is applied without brain-computer interface control. The study aims to assess clinical and physiological effects related to neurorehabilitation of upper limbs after spinal cord injury. Participants will be randomly assigned to one of two groups: one receiving functional electrical stimulation controlled by the brain-computer interface based on their intention to move their hand, and the other receiving sham stimulation that is not controlled by the brain-computer interface. The intervention lasts 7 weeks, during which hand movements are elicited using these devices to support rehabilitation. During the study, participants will undergo assessments at the start and after 7 weeks of treatment. These include tests measuring upper limb function such as the Action Research Arm Test, Upper Extremity Motor Score, and Capabilities of Upper Extremities Questionnaire. Secondary assessments include measures of independence and life satisfaction. The trial includes monitoring for safety and effectiveness of the interventions over this period, with participant involvement focused on these evaluations.
CONDITIONS
Brief Title
Efficacy of a Brain-Computer Interface Controlled Functional Electrical Stimulation Therapy for Spinal Cord Injury Neurorehabilitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 weeks
Participants receive therapy with brain-computer interface controlled functional electrical stimulation or a sham control for neurorehabilitation.
Weekly visits for therapy sessions
Trial Site Locations
Total: 1 location
1
Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra (National Institute of Rehabilitation)
Tlalpan, Mexico City, Mexico, 14389
Actively Recruiting
Research Team
J
Jessica Cantillo-Negrete, PhD
R
Ruben I Carino-Escobar, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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