EMPOWER Early Feasibility Study: Non-invasive BCI to Control a Wheelchair for People With Paralysis

Launched by SYNAPTRIX LABS INC. · Dec 5, 2023

Keywords

ClinConnect Summary

The EMPOWER Early Feasibility Study is exploring a new technology called Neuralis, which helps people with severe paralysis control a wheelchair using their brain activity. The device is a special headset that detects signals from the brain when a person focuses their attention. This allows users to move the wheelchair in the direction they want, helping them gain more independence and improve their quality of life. The study aims to determine if this technology is safe and effective for individuals with different neurologic conditions, including those recovering from a stroke or living with conditions like ALS or spinal cord injuries.

To participate in the study, individuals must be aged 18 and older and have severe weakness in their arms and legs (quadriparesis). They also need to be able to give consent, have someone to assist them during the study, and speak English. However, people with a history of seizures, certain psychiatric conditions, or who are not vaccinated against COVID-19 cannot participate. The study is not yet recruiting participants, but when it does, individuals can expect to engage in clinical tests to assess how well the Neuralis device works for them. Overall, this research holds promise for changing the way assistive technology can support those with mobility challenges.

Gender

ALL

Eligibility criteria

• 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