Implantable Brain-Computer Interface for Paralysis

Not currently recruiting at 2 trial locations

Overseen By Sara Onesi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Synchron Medical, Inc.

Disqualifiers: Immunosuppression, Anesthesia unsuitability, Allergies, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new brain implant, the Motor Neuroprosthesis (MNP), designed to help individuals with severe paralysis control digital devices through thought. The device bypasses damaged brain areas to restore signal transmission, enabling users to perform digital tasks without physical movement. Researchers aim to determine the implant's safety and effectiveness. Suitable candidates for this trial have severe paralysis, can provide consent, and can undergo certain medical procedures. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could transform lives.

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 or your doctor.

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

Research has shown that the motor neuroprosthesis (MNP), a type of brain-computer interface, is generally well-tolerated by people with severe paralysis. In one study with four patients, researchers safely implanted the device without major problems. Another study confirmed these findings, demonstrating that the device remained safe over a long period.

While these studies provide promising safety results, it is important to remember that this is advanced technology. Minor side effects and some risks are always possible with any medical device. However, for those considering this trial, the existing data is encouraging regarding the safety of this innovative treatment for restoring communication abilities. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Motor Neuroprosthesis (MNP) because it offers a groundbreaking method for assisting individuals with paralysis. Unlike traditional treatments that focus on physical therapies or external devices, the MNP is an implantable brain-computer interface. This means it directly connects to the brain to help restore movement by translating thoughts into actions. This innovative approach allows for more natural and intuitive control of movement, potentially offering a significant improvement in the quality of life for those affected by paralysis.

What evidence suggests that this brain-computer interface is effective for paralysis?

Research shows that the Motor Neuroprosthesis (MNP), which participants in this trial will receive, can help people with severe movement difficulties regain some control over digital devices. Studies indicate that MNP restores brain signals that bypass damaged nerves, enabling users to give digital commands. Early results suggest these devices lead to noticeable, though small, improvements in movement and quality of life for patients. In some cases, users control devices accurately, meaning the device follows their brain's instructions well. Overall, while more research is needed, the MNP appears promising in helping individuals with paralysis regain some independence. ^{6 7 8 9 10}

Who Is on the Research Team?

Edward Karst

Principal Investigator

Synchron, Inc.

Are You a Good Fit for This Trial?

This trial is for individuals with severe paralysis who can't be helped by current treatments but still have a working brain area that controls movement. They must be able to travel for tests, speak English, have someone to support them during the study, and give consent.

Inclusion Criteria

I am a suitable candidate for a brain or spine procedure.

Have a study partner

Able to give consent

Exclusion Criteria

You are allergic to the contrast dye used in medical tests.

I have had a pulmonary embolism before.

You are allergic to nickel.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation

Implantation of the motor neuroprosthesis medical device

1 week

1 visit (in-person)

Treatment

Participants use the implanted brain computer interface to control digital devices

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Motor Neuroprosthesis (MNP)

Trial Overview The COMMAND study is testing an implantable device called Motor Neuroprosthesis (MNP), which aims to help people with paralysis control digital devices using their thoughts by bypassing damaged nerves.

How Is the Trial Designed?

Group I: Single Experimental Treatment 1 Intervention

Implantation of the motor neuroprosthesis medical device.

Who Is Running the Clinical Trial?

Synchron Medical, Inc.

Lead Sponsor

Trials

3

Recruited

10+

Synchron Medical, Inc

Lead Sponsor

Trials

3

Recruited

10+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7848062/

Motor neuroprosthesis implanted with neurointerventional ... The study objectives included exploratory efficacy outcomes, including signal fidelity, control of multiple motor impulse commands with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6984639/

Motor neuroprosthesis for promoting recovery of function after ... We included the data for outcomes related to participation in the Stroke‐Specific Quality of Life (SSQoL) (Williams 1999), reported in two studies (Bethoux ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0003999324009109

Review Article (Meta-Analysis) Neural Interface-Based ... Neural interface–based motor rehabilitation resulted in significant, although modest, reductions in poststroke impairment and should be considered for wider ...

4. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2799839

Assessment of Safety of a Fully Implanted Endovascular ... The first in-human study evaluated if the endovascular BCI could be safely implanted and used by patients with paralysis to control a personal ...

5. archives-pmr.org archives-pmr.org/article/S0003-9993(24)00910-9/fulltext

Neural Interface-Based Motor Neuroprosthesis in ... Our results show that with the current BCI systems, although they can reduce impairment even in chronic stroke patients (many of whom have had functional ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9857731/

Assessment of Safety of a Fully Implanted Endovascular Brain ... A fully implanted endovascular brain-computer interface for severe paralysis in 4 patients: The Stentrode With Thought-Controlled Digital Switch (SWITCH) Study.

7. archives-pmr.org archives-pmr.org/article/S0003-9993(22)01152-2/fulltext

Long-Term Safety of a Fully Implanted Endovascular Brain ... This first-in-human study assessed safety of an implanted brain-computer interface (BCI). Secondary objective was feasibility of using the implant as a ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05035823

COMMAND Early Feasibility Study: Implantable BCI to ... The purpose of this research is to evaluate safety and feasibility. The MNP is a type of implantable brain computer interface which bypasses dysfunctional motor ...

9. jnis.bmj.com jnis.bmj.com/content/13/2/102

Motor neuroprosthesis implanted with neurointerventional ... We report preliminary early feasibility data demonstrating accurate multiple command control using a fully implanted endovascular motor neuroprosthesis ...

10. neurology.org neurology.org/doi/10.1212/WNL.0000000000201707

Interim Safety Profile From the Feasibility Study of ... This study provides Class IV evidence that the neurosurgically placed BrainGate Neural Interface system is associated with a low rate of SAEs.