BCI Technology for Paralysis

Overseen By Aryan Govil

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Synaptrix Labs Inc.

Disqualifiers: Seizures, Epilepsy, Psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Neuralis, a new headset that enables individuals with severe movement issues to control a wheelchair using brain signals. The goal is to determine if Neuralis is safe and effective in promoting independent movement. This trial may suit those with severe muscle weakness or paralysis who can consent and have a study partner. The technology seeks to improve quality of life by offering a non-invasive mobility solution. As an unphased trial, it provides a unique opportunity to contribute to groundbreaking research that could enhance mobility solutions for many.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What prior data suggests that this EEG headset is safe for individuals with severe neuromuscular conditions?

Research has shown that EEG devices, such as the Neuralis headset, are generally safe. EEG technology is non-invasive, meaning it doesn't involve surgery or entering the body. This method has shown promise in helping people with movement difficulties communicate and interact more easily.

Other studies have used EEG-based systems without major safety concerns. These devices are usually well-tolerated, and users have not reported serious side effects. However, some people with nerve or sensory issues might find it challenging to use the device effectively.

Neuralis aims to help people control wheelchairs using their brain signals, potentially improving their independence and quality of life. While specific safety data for Neuralis itself is not yet available, similar EEG-based technologies have a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Neuralis because it offers a non-invasive approach to managing paralysis using a unique EEG headband device. Unlike traditional treatments that might involve invasive surgeries or medications, Neuralis focuses on translating brain signals into actions through a simple wearable. This technology has the potential to enhance mobility and independence for individuals with paralysis without the risks associated with more aggressive interventions.

What evidence suggests that this device is effective for paralysis?

Research has shown that assistive technologies like Neuralis, studied in this trial, use brain signals to control devices and can improve movement for people with motor impairments. Participants will use a non-invasive EEG headband to read brain signals, enabling control of a wheelchair through focused attention. Although specific data on Neuralis is limited, similar technologies have helped people regain some movement and independence. These devices aim to enhance quality of life by providing a non-invasive, easy-to-use option for those with severe movement challenges. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with severe paralysis due to conditions like Multiple Sclerosis, Spinal Cord Injury, or ALS. Participants must be able to attend all tests, give consent, speak English fluently, and have a study partner. It's not suitable for those who can't use the device properly.

Inclusion Criteria

You are suitable for using the device.

I have severe weakness in all four limbs.

You are able to agree to participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Neuralis EEG headset to control a wheelchair, assessing safety and efficacy

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after using the device

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Neuralis

Trial Overview The EMPOWER study is testing Neuralis, a non-invasive brain-computer interface (BCI) that allows people with paralysis to control their wheelchairs using EEG signals from their visual cortex by focusing their attention.

How Is the Trial Designed?

Group I: Patient Group / Arm Experimental Treatment 1 Intervention

Use of non-invasive EEG headband device

Who Is Running the Clinical Trial?

Synaptrix Labs Inc.

Lead Sponsor

Trials

1

Recruited

6+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11962904/

The Current State of Outcome Measurements After ... Motor outcomes were reported in 52 of the 68 articles, 71% of which included manual muscle testing using the MRC scale. EMG was used in 40% of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11503389/

Evaluation of Rehabilitation Outcomes in Patients with ... The impairment “Complete impairment of structures of the nervous system” (ICF code: s110.40) was the most frequently encountered (64.14%).

3. iopscience.iop.org iopscience.iop.org/article/10.1088/1741-2552/ad200f

Clinical outcomes of peripheral nerve interfaces for ... We review the literature for clinical trials and studies containing clinical outcome measures to explore the utility of human applications of PNIs.

4. nature.com nature.com/articles/s41598-024-71983-2

Long-term outcome and predictors of neurological recovery ... Results showed 41% experienced AIS improvement, with 51% regaining ambulation over a median follow-up of 3.7 years. Significant AIS improvement ...

5. embs.org embs.org/tnsre/articles/estimating-upper-limb-impairment-level-in-stroke-survivors-using-wearable-inertial-sensors-and-a-minimally-burdensome-motor-task/

Estimating Upper-Limb Impairment Level in Stroke ... In this work, we propose an approach to estimate upper-limb impairment in stroke survivors using two wearable inertial sensors, on the wrist and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06169696

NCT06169696 | EMPOWER Early Feasibility Study: Non- ... 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 ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN200046.pdf

driven upper extremity powered exerciser. An EEG-dr The Neurolutions System should be used with caution in patients with nerve or sensory impairment that may limit or interfere with the patient's ability to sense ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8309653/

Noninvasive Electroencephalography Equipment for Assistive ... The EEG method is revealing the remarkable improvements and continuous changes, even though individuals with procured motor impairments regularly display ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10740927/

fNIRS-EEG BCIs for Motor Rehabilitation: A Review - PMC BCI plays a pivotal role in promoting smoother communication and interactions between individuals with motor impairments and others. Moreover, ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S1388245724002360

EEG-based sensorimotor neurofeedback for motor ... This scoping review maps the breadth of research exploring EEG-based sensorimotor neurofeedback in both children and adults with neurological motor impairment.