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Prosthetics

Visuomotor Prosthetic for Paralysis

N/A

Recruiting

Led By Ausaf Bari, MD, 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

A regular caregiver to monitor the surgical site

Pathology resulting in paralysis

Must not have

Intellectual impairment

Psychotic illness or chronic psychiatric disorder, including major depression if untreated

Timeline

Screening 3 weeks

Treatment Varies

Follow Up six years after array implantation

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at whether or not a brain-chip can be used to provide communication capabilities to severely paralyzed individuals. Five subjects will be enrolled and implanted with the NCS for a period of up to six years.

Who is the study for?

This trial is for individuals aged 22-65 with paralysis, able to give consent and follow instructions, who live close to the study site. They must have a caregiver, a support system, stable ventilator status, and be expected to live more than a year. Excluded are those with HIV/AIDS, active cancer, certain brain injuries or conditions preventing surgery or MRI scans.

What is being tested?

The trial tests a 'brain-chip' that lets severely paralyzed people control computers directly with their brain activity. Participants will learn to use this neural communication system over at least one year (up to six) to operate tablet computers for various tasks like making calls or controlling smart devices.

What are the potential side effects?

Potential side effects may include discomfort from the implantation of the device, risk of infection at surgical sites monitored by caregivers, possible inflammation due to foreign body reaction in the brain tissue around the chip.

Eligibility Criteria

Inclusion Criteria

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

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I have someone to help me watch my surgery area.

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I am paralyzed due to a medical condition.

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I can talk.

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I am between 22 and 65 years old.

Exclusion Criteria

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

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I have an intellectual disability.

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

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I have had a brain injury or surgery above the cerebellum.

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I currently have an infection or a fever without a known cause.

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I have sores or wounds on my scalp.

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I am living with HIV/AIDS.

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I am currently undergoing cancer treatment.

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My diabetes is not well-controlled with medication.

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

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I have had seizures in the past.

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I have health issues that make surgery or long-term device use unsafe.

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ six years after array implantation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~six years after array implantation

This trial's timeline: 3 weeks for screening, Varies for treatment, and six years 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

Subject control of a tablet computer

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 Communication SystemExperimental Treatment1 Intervention

The Neural Communication System consists of two Neuroport Multi-Port Arrays, which are descried in detail in the intervention description. One Neuroport Multi-Port Array is inserted into the posterior parietal cortex, an area of the brain used in reach planning. The second Neuroport Multi-Port Array is inserted into the motor cortex, which is primarily responsible for controlling movement. 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 use thought to control a simple computer environment or a tablet computer.

0 / 17Eligibility criteria met