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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new technology called MindEx, designed to help people with severe paralysis control computers using only their thoughts. The goal is to determine if this system can enhance independence and quality of life by enabling users to perform tasks like typing, drawing, or gaming. MindEx operates through tiny, implanted chips that transmit brain signals to a computer. The study seeks individuals with paralysis due to conditions such as spinal cord injury, brainstem stroke, or ALS, who can travel for regular study visits. Participants will learn to control a computer interface through thought, potentially gaining more freedom in daily activities. As an unphased trial, this study offers a unique opportunity to explore cutting-edge technology that could transform daily life for those with severe paralysis.

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 prior data suggests that this brain-computer interface technology is safe for humans?

Research shows that brain-computer interface (BCI) technologies like MindEx are generally easy for people to handle. Studies on similar BCI devices have demonstrated their safe use in helping patients regain certain abilities. For example, some studies have used BCIs with stroke patients to improve hand movement, and these patients showed significant improvement with few side effects.

MindEx is a new and innovative system, but it builds on existing BCI technology, suggesting it may be just as safe. Part of this treatment involves placing electrodes in the brain, a procedure performed in other studies with manageable risks. Current research does not indicate any major safety concerns for these devices, but since this is a first-of-its-kind study, researchers will closely monitor all potential risks.

Overall, while MindEx is new, it relies on proven technology used safely in other situations. Researchers will closely monitor participants in this trial to ensure any side effects are quickly addressed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for paralysis focus on physical rehabilitation or assistive devices to aid movement. But MindEx works differently, leveraging a brain-machine interface to directly translate thoughts into actions. This innovative approach uses implanted electrode arrays in key brain areas involved in movement and planning, allowing users to control devices like computers or tablets with their minds. Researchers are excited about MindEx because it promises a new level of independence for individuals with paralysis, offering the possibility to bridge the gap between intention and action in a way that traditional therapies can't.

What evidence suggests that the MindEx brain-computer interface is effective for enabling interaction for paralyzed individuals?

Research shows that brain-machine interfaces (BMIs) like MindEx, which participants in this trial will use, can help people who are paralyzed control computers with their thoughts. Studies on similar systems have found they can correctly interpret user intentions about 85.7% of the time. MindEx stands out because it uses signals from four different parts of the brain, unlike other systems that rely on just one or two. This capability helps the device understand more complex thoughts, making it easier for users to perform tasks like typing or playing games. Early results suggest that MindEx could significantly enhance independence and quality of life for people with severe paralysis. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05936619

Study Details | NCT05936619 | MindEx: A Novel, Multifocal ... This research study is being done to develop a novel brain-computer interface (BCI) technology that can enable severely paralyzed individuals to interact ...

2. withpower.com withpower.com/trial/phase-paralysis-8-2023-abea3

Brain-Machine Interface for Paralysis · Info for Participants What data supports the effectiveness of the treatment MindEx for paralysis? Research on brain-machine interfaces (BMIs) shows that these systems can help ...

3. ctv.veeva.com ctv.veeva.com/study/mindex-a-novel-multifocal-cognitive-brain-machine-interface-system

MindEx: A Novel, Multifocal, Cognitive Brain-Machine ... This research study is being done to develop a novel brain-computer interface (BCI) technology that can enable severely paralyzed ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6611552/

Brain machine interfaces: powerful tools for clinical treatment ... This article reviews the clinical and neuroscientific applications of BMIs, with a primary focus on motor BMIs. Keywords: brain machine interface, brain ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7729175/

Evaluation of a P300-Based Brain-Machine Interface ... On average, the system accuracy was 78.7% for target epochs and 85.7% for non-target trials. Additionally, we observed significant P300 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7825186/

Brain–computer interface robotics for hand rehabilitation after ... We report the first systematic examination of the literature on the use of BCI-robot systems for the rehabilitation of fine motor skills associated with hand ...

7. labmanager.com labmanager.com/mind-controlled-device-helps-stroke-patients-retrain-brains-to-move-paralyzed-hands-7243

Mind-Controlled Device Helps Stroke Patients Retrain ... After 12 weeks of using the device, the patients' scores increased an average of 6.2 points on a 57-point scale. “An increase of six points ...