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

Spinal Cord Injuries Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06169696
• Other study ID #: SYNL-01-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2024
• Est. completion date: January 2025

Study information

• Verified date: January 2024
• Source: Synaptrix Labs Inc.
• Contact: Aryan Govil
• Phone: 5107099964
• Email: aryan[@]synaptrix-labs.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Cervical Spinal Cord Injury
• Motor Neuron Disease
• Nervous System Diseases
• Neurologic Disorder
• Paralysis
• Quadriplegia
• Quadriplegia/Tetraplegia
• Sclerosis
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Device:
• Intervention/Treatment
Non-invasive EEG headband device

Locations

Country	Name	City	State
United States	Synaptrix Labs	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Synaptrix Labs Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device safety and efficacy	Number of patients who can comfortable and safely use device	1 month