Implantable Brain-Computer Interface for Paralysis

Recruiting at 2 trial locations

Overseen By Sara Onesi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Synchron Medical, Inc.

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

Compensation: Varies

Number of Visits: 1

Duration: 12 months

6 Participants Needed

Trial Summary

What is the purpose of this trial?

The Synchron motor neuroprosthesis (MNP) is intended to be used in subjects with severe motor impairment, unresponsive to medical or rehabilitative therapy and a persistent functioning motor cortex. 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 neurons. The device is designed to restore the transmission of neural signal from the cerebral cortex utilized for neuromuscular control of digital devices, resulting in a successful execution of non-mechanical digital commands.

Research Team

Edward Karst

Principal Investigator

Synchron, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+