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Neural Prosthetic System

Brain-Machine Interface for Quadriplegia

N/A

Recruiting

Led By Luke Bashford, PhD

Research Sponsored by Richard A. Andersen, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 22-65

High cervical spinal lesion

Must not have

Active cancer or chemotherapy

Diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year after array implantation

Awards & highlights

No Placebo-Only Group

Summary

This trial is being conducted to study a new brain-machine interface that may help people with spinal cord injuries control a computer or robotic limb.

Who is the study for?

This trial is for individuals aged 22-65 with high spinal cord injuries resulting in quadriplegia, who can communicate in English and follow instructions. They must have a support system, be able to travel to the study site frequently, and have someone to monitor them daily post-surgery. Exclusions include memory or psychiatric disorders, poor vision, certain infections or cancers, diabetes, seizures history, MRI contraindications among others.

What is being tested?

The trial tests a brain-machine interface called Neural Prosthetic System 2 (NPS2), which involves implanting electrodes into the brain to allow control of devices like robotic limbs using thoughts and sensory feedback. The safety and effectiveness of this experimental device will be evaluated.

What are the potential side effects?

Potential side effects may include discomfort at the electrode implantation sites on the scalp visible as small protrusions that can be covered by a hat or scarf. There's also a risk associated with surgical procedures such as infection or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 22 and 65 years old.

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I have a high spinal cord injury in my neck.

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I can talk.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently undergoing chemotherapy or have active cancer.

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I have diabetes.

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I have had seizures in the past.

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

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I have had surgery to repair my skull.

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

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I currently have an infection or unexplained fever.

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I have sores or broken skin on my scalp.

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I am living with HIV/AIDS.

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I cannot have an MRI or might need one during the study.

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I have had brain surgery that affected the function of my parietal lobe.

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I experience sudden high blood pressure due to a spinal cord injury.

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I have an intellectual disability.

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I do not have untreated major depression or chronic psychiatric disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year after array implantation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year after array implantation

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year after array implantation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Absence of infection or irritation

Patient control over the end effector (virtual or physical)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Neural Prosthetic System 2Experimental Treatment1 Intervention

The Neural Prosthetic System 2 consists of three Neuroport Arrays, which are described in detail in the intervention description. Two of the three Neuroport Arrays are inserted into the posterior parietal cortex, an area of the brain used in reach and grasp planning. The third Neuroport Array is inserted into somatosensory cortex, specifically S1 which represents sensory feedback for the hand and fingers. The arrays are inserted and the percutaneous pedestal is attached to the skull during a surgical procedure. Following surgical recovery the subject will participate in study sessions 3-5 times per week in which they will learn to control an end effector by thought augmented with sensory feedback via intracortical microstimulation. They will then use the end effector to perform various reach and grasp tasks.

0 / 17Eligibility criteria met