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Brain-Machine Interface for Paralysis

N/A

Waitlist Available

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

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

Must have

Surgical clearance

Paralysis resulting from cervical spinal cord injury (SCI), brainstem stroke (ischemic or hemorrhagic), or amyotrophic lateral sclerosis (ALS)

Must not have

Medical conditions contraindicating surgery and chronic implantation of a medical device

Chronic oral or intravenous use of steroids or immunosuppressive therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up six years after array implantation

Awards & highlights

No Placebo-Only Group

Summary

This trial is developing a technology to help paralyzed people control a computer with their brain, using four chips to decode meaningful information from brain activity. It can help with multiple applications, and could greatly improve the autonomy and quality of life for those affected. Two people are taking part in the study for up to 6 years.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include surgical site complications monitored by caregivers and behavioral changes due to the implantation of the device. The long-term impact of having chips implanted in multiple brain regions will be closely studied.

Eligibility Criteria

Inclusion Criteria

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

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I am cleared by a doctor for surgery.

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I have paralysis due to a spinal cord injury, stroke in the brainstem, or ALS.

Exclusion Criteria

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

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

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I am currently undergoing chemotherapy or have active cancer.

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I have had seizures in the past.

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I have been diagnosed with an intellectual impairment.

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I have poor eyesight.

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I am living with HIV/AIDS.

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I have had surgery to repair my skull.

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

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I have lesions or open wounds on my scalp.

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I have diabetes.

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I currently have an infection or unexplained fever.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time frame: annually, for six years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time frame: annually, for six years

This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame: annually, for six years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Competency in computer/tablet control

Continuous trajectory decoding

Efficacy of multiple brain regions for neural control over subsets of brain regions

+1 more

Secondary study objectives

Change in quality of life

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: Mind Extender (MindEx)Experimental Treatment1 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.

0 / 14Eligibility criteria met