Brain-Computer Interface for Paralysis

Overseen By Kate J Barnabe, MHA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a brain-computer interface (BCI) to assist individuals with paralysis or speech loss due to conditions like ALS, spinal cord injury, or stroke. The goal is to enhance their ability to use computers and smartphones at home with a small, portable device called Mobile iBCI. The trial will specifically assess the accuracy and user-friendliness of this mobile BCI. Suitable participants include those with tetraplegia or speech loss, with limited or no use of their arms and legs. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve daily communication for those facing severe mobility challenges.

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 consult with the trial coordinators for specific guidance.

What prior data suggests that this brain-computer interface is safe for use in individuals with paralysis?

Research shows that brain-computer interfaces (BCIs), such as the mobile iBCI in this study, are being developed to help people with paralysis gain independence. Previous studies have demonstrated the potential of BCIs, but challenges remain. For instance, invasive BCIs, similar to the mobile iBCI, can degrade over time, potentially affecting their performance.

Safety remains a top priority in BCI studies. Interim safety reports indicate that BCIs have generally been well-tolerated, with most participants not experiencing serious side effects. However, as these devices are still under investigation, some risks might not yet be fully understood. The ongoing nature of these studies shows that researchers are actively monitoring and addressing any emerging safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mobile iBCI for paralysis because it represents a significant advancement in brain-computer interface technology. Unlike traditional treatments that often rely on physical rehabilitation or assistive devices, this method uses advanced decoding algorithms embedded in a small, mobile neural processor. This innovation allows for more seamless and natural control over devices, potentially improving the quality of life for individuals with paralysis. Additionally, the portability of the system means it could be more easily integrated into daily life, offering users greater independence and flexibility.

What evidence suggests that this mobile iBCI is effective for improving independence in individuals with tetraplegia or inability to speak?

Research has shown that mobile brain-computer interfaces (BCIs) can significantly aid people with severe paralysis in communication and independence. In earlier studies, participants using similar devices achieved the fastest communication rates ever recorded for those with movement difficulties. These BCIs use tiny sensors placed in the brain to capture brain signals, which then control computers and mobile devices. Recent improvements aim to enhance the systems' accuracy, reliability, and ease of daily use. This trial will evaluate an enhanced iBCI, focusing on new decoding algorithms and methods embedded in a small, mobile neural processor. This technology aims to improve the quality of life for people with conditions like ALS, spinal cord injuries, or stroke by giving them more control over their surroundings. ^{2 6 7 8 9}

Who Is on the Research Team?

John D Simeral, PhD

Principal Investigator

Providence VA Medical Center, Providence, RI

Are You a Good Fit for This Trial?

This trial is for Veterans with severe paralysis or inability to speak due to conditions like ALS, spinal cord injury, stroke, and muscular dystrophy. Participants must have little or no use of their arms and legs.

Inclusion Criteria

I cannot use my arms and legs due to paralysis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Evaluation

Performance of new decoding algorithms and methods will be developed and embedded in a small, mobile neural processor. The utility of these will be assessed separately with participants in the BrainGate pilot clinical trial.

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after evaluation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mobile iBCI

Trial Overview

The study tests a mobile brain-computer interface (iBCI) designed to help paralyzed individuals operate computers and mobile devices using their thoughts. The device's accuracy and ease of use will be evaluated at home by participants.

How Is the Trial Designed?

Group I: Evaluation of an enhanced iBCI Experimental Treatment 1 Intervention

Performance of new decoding algorithms and methods will be developed and embedded in a small, mobile neural processor. The utility of these will be assessed separately with participants in the BrainGate pilot clinical trial, IDE.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

The BrainGate feasibility study, involving 14 adults with quadriparesis, demonstrated that the implanted microelectrode arrays had a low rate of serious adverse events (SAEs) over an average implantation duration of 872 days, with no device-related deaths or permanent disabilities.

The most common adverse event was skin irritation, and overall, the safety profile of the BrainGate Neural Interface system is comparable to other chronically implanted medical devices, suggesting a favorable risk/benefit ratio for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interim Safety Profile From the Feasibility Study of the BrainGate Neural Interface System. Rubin, DB., Ajiboye, AB., Barefoot, L., et al.[2023]

The study identifies six core risk domains associated with implantable brain-computer interfaces (BCIs), including safety, cognitive impairment, and privacy concerns, which are crucial for informed consent in clinical applications.

Additionally, the research highlights three further risk domains—identity, agency, and stigma—that are often overlooked in consent processes, emphasizing the need for comprehensive discussions about the implications of BCI technology with potential participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informed Consent in Implantable BCI Research: Identifying Risks and Exploring Meaning. Klein, E.[2018]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3985135/

Implants and Decoding for Intracortical Brain Computer ...

One goal of the technology is to help people with severe paralysis or limb loss. Key elements of an iBCI are the implanted sensor that records the neural ...

2.

advanced.onlinelibrary.wiley.com

advanced.onlinelibrary.wiley.com/doi/10.1002/advs.202501912

Toward the Clinical Translation of Implantable Brain ...

This systematic review characterizes the evolution of motor iBCI research and evaluates outcome measures used to assess device performance. We ...

3.

elifesciences.org

elifesciences.org/articles/18554

High performance communication by people with paralysis ...

Using this interface, all three participants achieved the highest BCI communication rates for people with movement impairment reported to date.

4.

nature.com

nature.com/articles/s41591-024-03341-8

A high-performance brain–computer interface for finger ...

We developed a high-performance, finger-based brain–computer-interface system allowing continuous control of three independent finger groups.

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05470478?term=AREA%5BConditionSearch%5D(Locked-in%20syndrome%20OR%20%22Cerebromedullospinal%20disconnection%22%20OR%20%22%20locked%20in%20syndrome%22%20OR%20%22%20locked-in%20state%22)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING)&rank=3

NCT05470478 | iBCI Optimization for Veterans With Paralysis

VA research has been advancing a high-performance brain-computer interface (BCI) to improve independence for Veterans and others living with tetraplegia or ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10074470/

Interim Safety Profile From the Feasibility Study of the ...

Brain-computer interfaces (BCIs) are being developed to restore mobility, communication, and functional independence to people with paralysis.

7.

iopscience.iop.org

iopscience.iop.org/article/10.1088/1741-2552/adc48c/pdf

5-year follow-up of a fully implanted brain–computer ...

Invasive intracortical BCIs have shown promise in clinical trials but degrade in the chronic period and tether patients to acquisition hardware.

8.

fda.gov

fda.gov/media/182567/download

Developing Implanted Brain-Computer Interface Clinical ...

I'm delighted to welcome you to the Joint FDA and NIH Workshop on Developing. Implanted Brain-Computer Interface Clinical Outcome Assessments to ...

9.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1094715923007547

Invasive Brain Computer Interface for Motor Restoration in ...

Invasive techniques of BCI show promise for the treatment of SCI, but there is currently no technology that can restore complete functional autonomy in ...