What is the mechanism of action of this treatment?

The Brain-Computer Interface (BCI) is a promising treatment for quadriplegia that translates neural signals directly from the brain into commands to control external devices, such as computer cursors or robotic limbs. This technology leverages the intact neural pathways in the brain to bypass damaged spinal cord regions, allowing patients to interact with their environment through thought alone. This is particularly significant for quadriplegia patients as it offers a potential pathway to regain independence and improve quality of life by enabling control over assistive devices. Other common treatments include physical therapy, occupational therapy, and the use of assistive technologies, all aimed at maximizing functional abilities and enhancing daily living activities.

What side effects are associated with this type of intervention?

Common treatments for quadriplegia, particularly those involving Brain-Computer Interface (BCI) systems, aim to enable control of devices through neural signals. While BCIs are still largely experimental, potential side effects may include infection at the implantation site, device malfunction, and the need for surgical revisions. Other treatments for quadriplegia, such as botulinum toxin injections, can lead to transient mild complications like pain at the injection site, muscle weakness, and flu-like symptoms. Long-term use of botulinum toxin has not shown significant prevention of contractures or reduction in the need for orthopedic surgery.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for quadriplegia involving brain-computer interfaces (BCIs) in the provided context. However, the BrainGate2 study is exploring the feasibility of using an intracortical neural interface system to allow individuals with tetraplegia to control a computer cursor and other assistive devices with their thoughts. This indicates ongoing research in the field, but no specific FDA-approved BCI treatments are detailed. Broadly, treatments for quadriplegia often focus on rehabilitation, assistive devices, and medications to manage symptoms and improve quality of life.

What other types of research exist?

Promising novel alternatives to Brain-Computer Interface (BCI) for quadriplegia patients include: 1) Transcranial Direct Current Stimulation (tDCS), which has shown potential in improving motor function and communication abilities. 2) Diaphragm Pacing, which can assist with respiratory function and may improve overall quality of life. 3) Non-invasive Ventilatory Support, which provides respiratory assistance without the need for invasive procedures. These alternatives offer different approaches to improving the quality of life and functional capabilities of quadriplegia patients.

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Neural Interface System

BrainGate2 Neural Interface for Quadriplegia (BrainGate2 Trial)

N/A

Recruiting

Led By Leigh R Hochberg, M.D., PH.D.

Research Sponsored by Leigh R. Hochberg, MD, PhD.

Eligibility Criteria Checklist

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

Must have

Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders

Complete or incomplete tetraplegia (quadriplegia)

Must not have

Chronic oral or intravenous steroids or immunosuppressive therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year post-implant evaluation period

Awards & highlights

No Placebo-Only Group

Summary

This study is evaluating whether people with tetraplegia may be able to control a computer cursor and other assistive devices with their thoughts.

Who is the study for?

This trial is for people with conditions like ALS, muscular dystrophy, or spinal cord injuries that have led to tetraplegia. Participants must live close to the study site and be able to use a computer screen even with vision correction. They can't join if they're on chronic steroids/immunosuppressants or have other serious diseases.

What is being tested?

The BrainGate2 study tests whether individuals with tetraplegia can control a computer cursor and other devices using their thoughts after having a sensor placed in their brain's motor cortex.

What are the potential side effects?

Potential side effects are not detailed here but may include risks associated with surgical implantation of the device, such as infection, bleeding, or damage to surrounding brain tissue.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have a diagnosed condition affecting my nerves or muscles, such as ALS or muscular dystrophy.

Select...

I have paralysis affecting all four limbs.

Select...

I have a condition affecting my nerves or muscles, like ALS or muscular dystrophy.

Select...

I have paralysis that affects all four of my limbs.

Exclusion Criteria

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

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year post-implant evaluation period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year post-implant evaluation period

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year post-implant evaluation period for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System.

Secondary study objectives

To investigate the feasibility of BrainGate2 and to establish the parameters for a larger clinical study, such as appropriate neural decoding algorithms, sample size, indices of measurement, success criteria, and endpoints.

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: BrainGateExperimental Treatment1 Intervention

BrainGate Neural Interface System

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Brain-Computer Interface (BCI) is a promising treatment for quadriplegia that translates neural signals directly from the brain into commands to control external devices, such as computer cursors or robotic limbs. This technology leverages the intact neural pathways in the brain to bypass damaged spinal cord regions, allowing patients to interact with their environment through thought alone. This is particularly significant for quadriplegia patients as it offers a potential pathway to regain independence and improve quality of life by enabling control over assistive devices. Other common treatments include physical therapy, occupational therapy, and the use of assistive technologies, all aimed at maximizing functional abilities and enhancing daily living activities.

Interventions to Improve Movement and Functional Outcomes in Adult Stroke Rehabilitation: Review and Evidence Summary.Restoring walking after spinal cord injury: operant conditioning of spinal reflexes can help.Therapeutic synergism in the treatment of post-stroke arm paresis utilizing botulinum toxin, robotic therapy, and constraint-induced movement therapy.