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

NCT05343130 | Recruiting DMC

• 1 other identifier: 10/22
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cervical Spinal Cord Injury

Keywords

brain-computer interface; functional electrical stimulation; motor rehabilitation; tetraplegia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Spinal Cord Independence Measure III (SCIM-III)

  At enrollment and after 7 weeks of the intervention onset

• Life Satisfaction Questionnaire 9 (LISAT-9)

  At enrollment and after 7 weeks of the intervention onset

Study Arms (2)

Brain-Computer Interface controlled functional electrical stimulation feedback

EXPERIMENTAL

Device: Brain-Computer Interface

Sham Brain-Computer Interface controlled functional electrical stimulation feedback

SHAM COMPARATOR

Device: Sham Brain-Computer Interface

Interventions

Brain-Computer Interface DEVICE

Hand movement will be elicited using functional electrical stimulation activated by the brain-computer interface based on hand movement intention.

Brain-Computer Interface controlled functional electrical stimulation feedback

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.

Sham Brain-Computer Interface controlled functional electrical stimulation feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Rehabilitacion: lead
• Instituto Tecnologico y de Estudios Superiores de Monterey: collaborator

Study Sites (1)

Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra (National Institute of Rehabilitation)

Tlalpan, Mexico City, 14389, Mexico

RECRUITING

MeSH Terms

Conditions

Quadriplegia

Interventions

Brain-Computer Interfaces

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Jessica Cantillo-Negrete, PhD

  Instituto Nacional de Rehabilitacion (National Institute of Rehabilitation)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Cantillo-Negrete, PhD

CONTACT

+525559991000; jcantillo@inr.gob.mx

Ruben I Carino-Escobar, PhD

CONTACT

+525559991000; ricarino@inr.gob.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher in Medical Sciences

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 25, 2022
• Study Start: August 1, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Six months after publication
• Access Criteria: Researchers that make a request for access data and their request is approved by the National Institute of Rehabilitation Ethics Committee

Locations

ME (1)