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

Not Applicable

Recruiting

• Conditions: Cervical Spinal Cord Injury
• Interventions: Device: Brain-Computer Interface; Device: Sham Brain-Computer Interface

• Registration Number: NCT05343130
• Lead Sponsor: Instituto Nacional de Rehabilitacion

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-18
• Study First Submitted QC: 2022-04-18
• Study First Posted: 2022-04-25
• Study Start: 2022-08-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-12
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brain-Computer Interface controlled functional electrical stimulation feedback	Brain-Computer Interface	-
Sham Brain-Computer Interface controlled functional electrical stimulation feedback	Sham Brain-Computer Interface	-

Primary Outcome Measures

Name	Time	Method
Capabilities of Upper Extremities Questionnaire (CUE-Q)	At enrollment and after 7 weeks of the intervention onset	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.
Action Research Arm Test (ARAT)	At enrollment and after 7 weeks of the intervention onset	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.
Upper Extremity Motor Score (UEMS)	At enrollment and after 7 weeks of the intervention onset	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.

Secondary Outcome Measures

Name	Time	Method
Spinal Cord Independence Measure III (SCIM-III)	At enrollment and after 7 weeks of the intervention onset	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.
Life Satisfaction Questionnaire 9 (LISAT-9)	At enrollment and after 7 weeks of the intervention onset	Change of life satisfaction. Scale ranges from 0 to 54 points. A higher score is expected with a better life satisfaction.

Trial Locations

Locations (1)

Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra (National Institute of Rehabilitation); 🇲🇽 Tlalpan, Mexico City, Mexico