Clinical trial NCT06169696: EMPOWER Early Feasibility Study: Non-invasive BCI to Control a Wheelchair for People With Paralysis
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neurologic Disorder
Paralysis
Paralysis; Stroke
Amyotrophic Lateral Sclerosis
Spinal Cord Injuries
Cervical Spinal Cord Injury
Tetraplegic; Paralysis
Quadriplegia/Tetraplegia
Keywords: Amyotrophic Lateral Sclerosis
Quadriplegia/Tetraplegia
Lead sponsor: Synaptrix Labs Inc.
Sponsor class: INDUSTRY
First posted: 2023-12-13
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.

Detailed description: Neuralis, developed by Synaptrix Labs, is an innovative assistive technology engineered to restore mobility and independence for individuals grappling with severe neuromuscular conditions. This cutting-edge device operates through a discreet and non-invasive EEG headset, comprising strategically placed dry sensors at on the occipital lobe, precisely targeting the visual cortex region.

The key breakthrough lies in Neuralis' capability to extract brain activity from subtle eye movements. Through this interaction, Neuralis decodes subtle EEG signals, effectively translating them into precise wheelchair navigation commands.

The device interfaces seamlessly with a user-friendly Neuralis mobile app, serving as the central control hub. This intuitive application handles calibration settings, connectivity, and destination selections through a simplified visual click-based protocol. The slim BCI headset captures EEG data, transmitting it via Bluetooth to the connected smartphone. Subsequently, the data is relayed to a secure cloud server, which houses an advanced computational infrastructure employing edge computing principles for optimal response times.

Within this cloud environment, a proprietary machine learning pipeline for EEG decoding and intent classification operates. Certain latency-sensitive steps run on the phone, while the cloud handles additional model training and personalization, leveraging scalable processing power. This dynamic architecture ensures a swift and near-instantaneous translation of the user's movement intentions into seamless wheelchair maneuverability.

What sets Neuralis apart is its ability to deliver robust functionality in a discreet, user-friendly manner. Its lightweight construction, comprising only four sensors, maximizes comfort while capturing essential visual cortex signals vital for nimble maneuvering. This fusion of advanced neurotechnology and user-centric design positions Neuralis as a significant leap forward in assistive devices, bridging the gap between usability and high-performance functionality for individuals with severe neuromuscular conditions.

Neuralis is completely non-invasive and built from stable, off the shelf parts. All data is encrypted.

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

Primary outcomes:
measure: Device safety and efficacy
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Synaptrix Labs
state: New York
Study officials:
References: