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

NCT ID: NCT06169696

Last Updated: 2024-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-30

Study Completion Date

2025-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patient Group / Arm

Use of non-invasive EEG headband device

Group Type OTHER

Intervention/Treatment

Intervention Type DEVICE

Non-invasive EEG headband device

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intervention/Treatment

Non-invasive EEG headband device

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Neuralis by Synaptrix Labs

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Synaptrix Labs Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Synaptrix Labs

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Aryan Govil

Role: CONTACT

5107099964

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Aryan Govil

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SYNL-01-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.