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

2 Participants Needed

Trial Summary

What is the purpose of this trial?

VA research has been advancing a high-performance brain-computer interface (BCI) to improve independence for Veterans and others living with tetraplegia or the inability to speak resulting from amyotrophic lateral sclerosis, spinal cord injury or stoke. In this project, the investigators enhance deep learning neural network decoders and multi-state gesture decoding for increased accuracy and reliability and deploy them on a battery-powered mobile BCI device for independent use of computers and touch-enabled mobile devices at home. The accuracy and usability of the mobile iBCI will be evaluated with participants already enrolled separately in the investigational clinical trial of the BrainGate neural interface.

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 data supports the effectiveness of the treatment Mobile iBCI for paralysis?

Research shows that brain-computer interfaces (BCIs) can help people with paralysis communicate and control devices by translating brain signals into commands. Studies have demonstrated that BCIs can improve communication speed and accuracy, making them promising tools for enhancing independence in people with severe paralysis. ^{1 2 3 4 5}

Is the Brain-Computer Interface for Paralysis generally safe for humans?

The BrainGate feasibility study, the largest and longest-running clinical trial of an implanted brain-computer interface (BCI), provides some safety data, but the long-term safety of these devices in humans is still not fully known. The study highlights the importance of understanding potential risks, including short and long-term safety, cognitive and communicative impairment, and privacy concerns. ^{6 7 8 9 10}

How is the Mobile iBCI treatment unique for paralysis?

The Mobile iBCI treatment is unique because it uses a brain-muscle-computer interface that allows paralyzed individuals to control devices through a mobile phone by interpreting signals from facial muscles, providing a novel way to interact with technology without relying on traditional muscle movement. ^{2 11 12 13 14}

Research Team

John D Simeral, PhD

Principal Investigator

Providence VA Medical Center, Providence, RI

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Evaluating the clinical benefit of brain-computer interfaces for control of a personal computer. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Brain-computer interfaces--the key for the conscious brain locked into a paralyzed body. [2007]

3. England pubmed.ncbi.nlm.nih.gov

High performance communication by people with paralysis using an intracortical brain-computer interface. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Auto-deleting brain machine interface: Error detection using spiking neural activity in the motor cortex. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Classification of mouth movements using 7 T fMRI. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Interim Safety Profile From the Feasibility Study of the BrainGate Neural Interface System. [2023]

7. England pubmed.ncbi.nlm.nih.gov

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

8. Canada pubmed.ncbi.nlm.nih.gov

The Ethical and Responsible Development and Application of Advanced Brain Machine Interfaces. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

What would brain-computer interface users want: opinions and priorities of potential users with spinal cord injury. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

The Asilomar Survey: Stakeholders' Opinions on Ethical Issues Related to Brain-Computer Interfacing. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Brain-computer interface technology: a review of the Second International Meeting. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Brain-muscle-computer interface: mobile-phone prototype development and testing. [2021]

13. China pubmed.ncbi.nlm.nih.gov

[Research progress on application of brain-computer-interface in mobile peripheral control]. [2011]

14. United States pubmed.ncbi.nlm.nih.gov

Feasibility of using discrete Brain Computer Interface for people with Multiple Sclerosis. [2022]