Visual Interface System for Improved Navigation and Accessibility Through EEG, Allowing for an EEG-driven Mobility Platform Offering Wheelchair-enabled Engagement and Rehabilitation (EMPOWER): An Early Feasibility Study (EFS) of Safety and Efficacy in Subjects With Severe Quadriplegia

Trial ID: NCT06169696

Interventional - Phase Unknown - Unknown status

Neuralis is an innovative assistive technology designed for individuals with severe neuromuscular conditions, enabling wheelchair control through EEG signals. This study aims to assess the safety, feasibility, and efficacy of Neuralis in restoring mobility and independence. The device is a discreet EEG headset which specializes in decoding signals from visual cortex, allowing users to initiate precise wheelchair movements through focused attention. This research seeks to demonstrate Neuralis' potential in revolutionizing assistive technology by offering a non-invasive, user-friendly solution for individuals facing motor impairments, ultimately enhancing their quality of life.

Conditions

• Neurologic Disorder
• Paralysis
• Paralysis; Stroke
• Amyotrophic Lateral Sclerosis
• Spinal Cord Injuries
• Cervical Spinal Cord Injury
• Tetraplegic; Paralysis
• Quadriplegia/Tetraplegia

Interventions

• Intervention/Treatment

Eligibility

Inclusion criteria

• 1. Severe quadriparesis
• 2. Able to give consent
• 3. Appropriate candidate for device
• 4. Able and willing to access all clinical testing and not impeded by geographical location
• 5. Proficient in English
• 6. Have a study partner

Exclusion criteria

• 1. History of seizures
• 2. History of epilepsy
• 3. Psychiatric or psychological disorder
• 4. No study partner or caregiver
• 5. Unable to provide evidence of COVID vaccination

Sponsor

Synaptrix Labs Inc.

Source: ClinicalTrials.gov

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