Neurologic DisorderNCT06169696
EMPOWER Early Feasibility Study: Non-invasive BCI to Control a Wheelchair for People With Paralysis
A study testing Intervention/Treatment in people with Neurologic Disorder and Paralysis, run by Synaptrix Labs Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Neurologic Disorder, Paralysis, Paralysis; Stroke
- What is being tested?
- Intervention/Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2024to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of seizures
- History of epilepsy
- Psychiatric or psychological disorder
- No study partner or caregiver
- Unable to provide evidence of COVID vaccination
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Neurologic Disorder, Paralysis, Paralysis; Stroke, Amyotrophic Lateral Sclerosis, Spinal Cord Injuries, Cervical Spinal Cord Injury
- Being tested
- Intervention/Treatment
- Keywords
- Amyotrophic Lateral Sclerosis, Quadriplegia/Tetraplegia
- Medical subject headings
- Nervous System Diseases, Paralysis, Stroke, Amyotrophic Lateral Sclerosis, Spinal Cord Injuries, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention/TreatmentDevice
Also called Neuralis by Synaptrix Labs
Non-invasive EEG headband device
| Study group | Role | What they receive |
|---|---|---|
| Patient Group / Arm | Other | Use of non-invasive EEG headband device Receives: Device: Intervention/Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device safety and efficacy
Number of patients who can comfortable and safely use device
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study startNov 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synaptrix Labs Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169696
- Sponsor's protocol ID
- SYNL-01-01
- Status last verified
- Jan 2024
- First submitted
- 5 Dec 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06169696
- Acronym / sponsor ID
- SYNL-01-01
- Conditions
- Neurologic Disorder, Paralysis, Paralysis; Stroke, Amyotrophic Lateral Sclerosis, Spinal Cord Injuries, Cervical Spinal Cord Injury
- Keywords
- Amyotrophic Lateral Sclerosis, Quadriplegia/Tetraplegia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Synaptrix Labs Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Group / Arm | Other | Device: Intervention/TreatmentUse of non-invasive EEG headband device |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- History of seizures
- History of epilepsy
- Psychiatric or psychological disorder
- No study partner or caregiver
- Unable to provide evidence of COVID vaccination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention/TreatmentAlso: Neuralis by Synaptrix LabsNon-invasive EEG headband device | Device | Patient Group / Arm |
Primary outcome
Device safety and efficacy
Time frame: 1 month
Number of patients who can comfortable and safely use device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: No. IPD will not be available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention/Treatment in people with Neurologic Disorder and Paralysis, run by Synaptrix Labs Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aryan Govil (5107099964, aryan@synaptrix-labs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device safety and efficacy (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.