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

NCT06169696 | Unknown

• 1 other identifier: SYNL-01-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Amyotrophic Lateral Sclerosis; Quadriplegia/Tetraplegia

Outcome Measures

Primary Outcomes (1)

• Device safety and efficacy

  Number of patients who can comfortable and safely use device

  1 month

Study Arms (1)

Patient Group / Arm

OTHER

Use of non-invasive EEG headband device

Device: Intervention/Treatment

Interventions

Intervention/Treatment DEVICE

Non-invasive EEG headband device

Also known as: Neuralis by Synaptrix Labs

Patient Group / Arm

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of seizures
• History of epilepsy
• Psychiatric or psychological disorder
• No study partner or caregiver
• Unable to provide evidence of COVID vaccination

Sponsors & Collaborators

• Synaptrix Labs Inc.: lead

Study Sites (1)

Synaptrix Labs

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Nervous System Diseases; Paralysis; Stroke; Amyotrophic Lateral Sclerosis; Spinal Cord Injuries; Quadriplegia

Interventions

Methods; Therapeutics

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Spinal Cord Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Aryan Govil

CONTACT

5107099964; aryan@synaptrix-labs.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: November 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)