- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06169696
EMPOWER Early Feasibility Study: Non-invasive BCI to Control a Wheelchair for People With Paralysis
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aryan Govil
- Phone Number: 5107099964
- Email: aryan@synaptrix-labs.com
Study Locations
-
-
New York
-
New York, New York, United States, 10010
- Synaptrix Labs
-
Contact:
- Aryan Govil
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Severe quadriparesis
- Able to give consent
- Appropriate candidate for device
- Able and willing to access all clinical testing and not impeded by geographical location
- Proficient in English
- Have a study partner
Exclusion Criteria:
- History of seizures
- History of epilepsy
- Psychiatric or psychological disorder
- No study partner or caregiver
- Unable to provide evidence of COVID vaccination
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Patient Group / Arm
Use of non-invasive EEG headband device
|
Non-invasive EEG headband device
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Device safety and efficacy
Time Frame: 1 month
|
Number of patients who can comfortable and safely use device
|
1 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Metabolic Diseases
- Central Nervous System Diseases
- Neurologic Manifestations
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Trauma, Nervous System
- Spinal Cord Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Sclerosis
- Wounds and Injuries
- Motor Neuron Disease
- Amyotrophic Lateral Sclerosis
- Nervous System Diseases
- Paralysis
- Spinal Cord Injuries
- Quadriplegia
Other Study ID Numbers
- SYNL-01-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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