Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06169696
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-18
First Post:
2023-12-05
Brief Title:
EMPOWER Early Feasibility Study Non-invasive BCI to Control a Wheelchair for People With Paralysis
Sponsor:
Synaptrix Labs Inc
Organization:
Synaptrix Labs Inc
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 users 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
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 users 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None