Brain-Machine Interface for Paralysis

Overseen By Aniah Daniels, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Steroids, Immunosuppressive therapy

Disqualifiers: Memory problems, Untreated depression, Cancer, Diabetes, others

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

Compensation: Varies

Number of Visits: 6

2 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is being done to develop a novel brain-computer interface (BCI) technology that can enable severely paralyzed individuals to interact with the world through direct brain-control of a computer. This technology is named MindEx (for Mind Extender). It utilizes four implanted "chips" in the human brain from which investigators can record brain activity during subjects' thoughts and decode meaningful information from this activity to be used as control signals for a computer, a laptop, or a tablet. The use of four brain regions is a significant differentiating feature and scientific innovation of this study over much prior work in this space, that typically derived control signals from one, or sometimes two brain regions. The brain regions to be used here can allow the decode of multiple variables simultaneously, including not just moment-to-moment position, but also high-level goals, intentions, decisions, scene comprehension, and error-related signals involved in natural human behavior. The research is being done through a prospective, longitudinal, single-arm early feasibility study to examine the safety and effectiveness of using MindEx to provide the user an intuitive, efficient, and accurate ability to control multiple applications on a computer interface such as a word processor, a paint application, or to play simple video games. Such versatility could greatly improve the autonomy and quality of life of severely paralyzed individuals. Two subjects will be enrolled, each implanted with MindEx for a period of at least 53 weeks and up to 313 weeks. The study is expected to take at least one year and up to six years in total.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on chronic oral or intravenous steroids or immunosuppressive therapy, you may not be eligible to participate.

What data supports the effectiveness of the treatment MindEx for paralysis?

Research on brain-machine interfaces (BMIs) shows that these systems can help people with paralysis control devices and regain some movement and communication abilities. Studies have demonstrated that BMIs can enable neural control over robotic and virtual devices, and continuous use has been linked to partial recovery in spinal cord injury patients. ^{1 2 3 4 5}

Is the Brain-Machine Interface for Paralysis 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. There are identified risks such as cognitive and communicative impairment, privacy and security concerns, and potential impacts on identity and agency. ^{4 6 7 8 9}

How does the Brain-Machine Interface treatment for paralysis differ from other treatments?

The Brain-Machine Interface (BMI) treatment is unique because it directly connects the brain to external devices, allowing people with paralysis to control assistive technologies or reanimate muscles using brain signals. Unlike traditional therapies, BMIs use sensors to detect brain activity and translate it into commands, offering a novel way to restore mobility and communication for those with severe motor impairments. ^{3 4 10 11 12}

Eligibility Criteria

This trial is for severely paralyzed individuals with a life expectancy over 12 months, who can follow instructions and travel to the study site regularly. They must have paralysis due to cervical SCI, brainstem stroke, or ALS. Excluded are those with memory issues, intellectual impairments, certain medical conditions or devices that conflict with surgery or MRI use.

Inclusion Criteria

You have a support system to help with your emotions and mental well-being.

Provide informed consent

My caregiver checks me daily for surgery complications and changes in my behavior.

Exclusion Criteria

I have health issues that prevent me from having surgery or getting a long-term medical device.

I am not on long-term steroids or drugs that weaken my immune system.

You have a shunt for hydrocephalus.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Implantation and Recovery

Participants undergo surgical implantation of the MindEx system and recover from the procedure

4-6 weeks

1 surgical visit, multiple recovery visits

Training and Use

Participants learn to use the MindEx system to control applications on a computer, a laptop, or a tablet

53-313 weeks

Up to 5 sessions per week

Follow-up

Participants are monitored for safety and effectiveness after the main study period

6 years

Treatment Details

Interventions

• MindEx

Trial Overview The MindEx system uses four implanted brain 'chips' to decode thoughts into computer control signals. This single-arm study tests its safety and effectiveness in allowing users to operate applications like word processors and games on a computer interface.

Participant Groups

Group I: Mind Extender (MindEx) Experimental Treatment 1 Intervention

MindEx consists of two Neuroport Multi-Port Arrays, described in detail in the intervention description. Each NeuroPort Multi-Port Array comprises two electrode arrays implanted into human brain tissue, for a total of four electrode arrays. These will be in 1) prefrontal cortex, a brain area involved in scene comprehension, action selection, and error signaling, 2) premotor cortex, a brain area involved in planning ongoing and upcoming actions, 3) posterior parietal cortex, a brain area involved in processing sensory-to-motor transformations during movements, and 4) primary motor cortex, responsible for controlling movement. The pair of electrode arrays in each NeuroPort Multi-Port Array connect to a single percutaneous pedestal attached to the skull during a surgical procedure. Following recovery from the surgical placement, subjects will participate in study sessions up to 5 times a week. They will learn to use thought to control applications on a computer, a laptop, or a tablet.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Srinivas Chivukula

Lead Sponsor

Trials

1

Recruited

2+

Nader Pouratian

Lead Sponsor

Trials

4

Recruited

20+

Findings from Research

Neural interface systems (NISs) are promising devices that allow individuals with paralysis to control assistive technologies using brain signals, showing potential for reanimating muscles based on direct commands from the brain.

Initial pilot trials using an intracortical microelectrode sensor have demonstrated that even years after injury, neurons in the motor cortex can still be engaged to operate devices, indicating the lasting potential of brain signals for functional recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assistive technology and robotic control using motor cortex ensemble-based neural interface systems in humans with tetraplegia. Donoghue, JP., Nurmikko, A., Black, M., et al.[2018]

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]

Invasive brain-machine interfaces (BMIs) have made significant advancements over the past two decades, particularly in their ability to record high-resolution neural signals, which is crucial for restoring motor functions in paralyzed individuals.

The transition of BMI technology from successful animal research to clinical trials shows promise in helping people regain lost motor abilities, highlighting both the potential benefits and the challenges that lie ahead in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Invasive Brain Machine Interface System. Jin, Y., Chen, J., Zhang, S., et al.[2020]

References

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

Training locked-in patients: a challenge for the use of brain-computer interfaces. [2009]

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

Bridging the brain to the world: a perspective on neural interface systems. [2008]

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

Brain-Machine Interfaces: From Basic Science to Neuroprostheses and Neurorehabilitation. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Assistive technology and robotic control using motor cortex ensemble-based neural interface systems in humans with tetraplegia. [2018]

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

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

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

Invasive Brain Machine Interface System. [2020]

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

Initial on-line evaluations of the LF-ASD brain-computer interface with able-bodied and spinal-cord subjects using imagined voluntary motor potentials. [2006]

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

Dynamic Ensemble Bayesian Filter for Robust Control of a Human Brain-Machine Interface. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Temporal coding of brain patterns for direct limb control in humans. [2021]