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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year post-implant evaluation period

Awards & highlights

BrainGate2 Trial Summary

This trial is to test a new way for people with tetraplegia to control devices with their thoughts, to see if it's safe and works.

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.Check my eligibility

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.See study design

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.

BrainGate2 Trial Eligibility Criteria

Inclusion Criteria

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

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

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I have paralysis affecting all four limbs.

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

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I have paralysis that affects all four of my limbs.

BrainGate2 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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.

BrainGate2 Trial Design

1Treatment groups

Experimental Treatment

Group I: BrainGateExperimental Treatment1 Intervention

BrainGate Neural Interface System

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

US Department of Veterans AffairsFED

868 Previous Clinical Trials

487,875 Total Patients Enrolled

6 Trials studying Quadriplegia

92 Patients Enrolled for Quadriplegia

Leigh R. Hochberg, MD, PhD.Lead Sponsor

2 Previous Clinical Trials

4 Total Patients Enrolled

2 Trials studying Quadriplegia

4 Patients Enrolled for Quadriplegia

National Institute on Deafness and Other Communication Disorders (NIDCD)NIH

330 Previous Clinical Trials

178,456 Total Patients Enrolled

2 Trials studying Quadriplegia

4 Patients Enrolled for Quadriplegia

Media Library

BrainGate2 (Neural Interface System) Clinical Trial Eligibility Overview. Trial Name: NCT00912041 — N/A

Quadriplegia Research Study Groups: BrainGate

Quadriplegia Clinical Trial 2023: BrainGate2 Highlights & Side Effects. Trial Name: NCT00912041 — N/A

BrainGate2 (Neural Interface System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00912041 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the demographic requirement for this medical study set at twenty years or older?

"The cut-off age for this medical trial is 80 years old, and the lower limit of eligibility is 18."

Answered by AI

How many individuals have enrolled in this clinical experiment?

"Affirmative, the listing on clinicaltrials.gov reveals that this trial is actively seeking volunteers, who were first posted about back in May 1st 2009 and was last edited September 19th 2022. To date, 15 individuals have to be recruited from 5 distinct sites."

Answered by AI

Is the enrollment phase of this trial still open?

"Yes, the information present on clinicaltrials.gov demonstrates that this medical trial is actively enrolling participants. Initially posted on May 1st 2009 and recently updated on September 19th 2022, the study seeks to recruit 15 patients from 5 distinct sites."

Answered by AI

Are Canadian healthcare facilities conducting experiments involving this clinical trial?

"Five clinical sites are presently recruiting participants for this trial, including those located in Atlanta, Stanford and Providence as well as 5 others. To mitigate travel concerns, choosing the closest facility is recommended if you decide to participate."

Answered by AI

Am I eligible to join this research initiative?

"This experiment requires 15 individuals affected by amyotrophic lateral sclerosis, aged 18 to 80 years old. Applicants must have a clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, or other motor neuron diseases; be suffering from complete or incomplete tetraplegia (quadriplegia); and live within three hours distance of the Study location. Additional inclusion criteria also apply."

Answered by AI