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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Spinal Cord Injury
• Intervention / Treatment: Device: Brain-Computer Interface; Device: Sham Brain-Computer Interface

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Cantillo-Negrete, PhD; Phone Number: 19008 +525559991000; Email: jcantillo@inr.gob.mx
• Study Contact Backup: Name: Ruben I Carino-Escobar, PhD; Phone Number: 19008 +525559991000; Email: ricarino@inr.gob.mx

Study Locations

• Mexico
  • Mexico City
    • Tlalpan, Mexico City, Mexico, 14389
      • Recruiting
      • Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra (National Institute of Rehabilitation)
      • Contact: Ruben I. Carino-Escobar, PhD; Phone Number: 19008 +52 55 59991000; Email: ricarino@inr.gob.mx
      • Contact: Jessica Cantillo-Negrete, PhD; Phone Number: 19008 +52 55 59991000; Email: jcantillo@inr.gob.mx
      • Principal Investigator: Jessica Cantillo-Negrete, PhD
      • Sub-Investigator: Ruben I. Carino-Escobar, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brain-Computer Interface controlled functional electrical stimulation feedback	Device: Brain-Computer Interface; Hand movement will be elicited using functional electrical stimulation activated by the brain-computer interface based on hand movement intention.
Sham Comparator: Sham Brain-Computer Interface controlled functional electrical stimulation feedback	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Instituto Nacional de Rehabilitacion
• Collaborators: Instituto Tecnologico y de Estudios Superiores de Monterey
• Investigators: Principal Investigator: Jessica Cantillo-Negrete, PhD, Instituto Nacional de Rehabilitacion (National Institute of Rehabilitation)

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: functional electrical stimulation; tetraplegia; brain-computer interface; motor rehabilitation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 10/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data collected during the study will be available to other researchers from the principal investigator on reasonable request
• IPD Sharing Time Frame: Six months after publication
• IPD Sharing Access Criteria: Researchers that make a request for access data and their request is approved by the National Institute of Rehabilitation Ethics Committee
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No