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

Cervical Spinal Cord Injury Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05343130
• Other study ID #: 10/22
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Instituto Nacional de Rehabilitacion
• Contact: Jessica Cantillo-Negrete, PhD
• Phone: +525559991000
• Email: jcantillo[@]inr.gob.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Spinal Cord Injury
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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 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.

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra (National Institute of Rehabilitation)	Tlalpan	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Rehabilitacion	Instituto Tecnologico y de Estudios Superiores de Monterey

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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