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Brain-Computer Interface

BrainGate Neural Interface for Tetraplegia (BG-Tablet-01 Trial)

N/A
Recruiting
Led By Leigh R Hochberg, MD, 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
Complete or incomplete tetraplegia (quadriplegia)
Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders
Must not have
Chronic oral or intravenous steroids or immunosuppressive therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to develop a brain-computer interface that can help people with conditions like stroke or ALS who are unable to move or speak. The interface would allow them to use communication apps on tablets using

Who is the study for?
This trial is for individuals with severe paralysis due to conditions like brainstem stroke, ALS (Lou Gehrig's Disease), or spinal cord injuries leading to quadriplegia. Participants should be unable to move or speak but remain alert. Specific inclusion and exclusion criteria details are not provided.
What is being tested?
The BrainGate2 Neural Interface System is being tested. It's a cutting-edge technology designed to interpret brain signals and enable people with paralysis to use communication apps on tablets using their thoughts.
What are the potential side effects?
Potential side effects are not explicitly listed, but the device involves a brain implant which may carry risks such as infection, bleeding, or damage at the implantation site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have paralysis in all four limbs.
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I have a condition affecting my nerves or muscles, like ALS or muscular dystrophy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not on long-term steroids or drugs that weaken my immune system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant

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: BrainGate Neural Interface SystemExperimental Treatment1 Intervention
Device: BrainGate Neural Interface System

Find a Location

Who is running the clinical trial?

Stanford UniversityOTHER
2,491 Previous Clinical Trials
17,519,067 Total Patients Enrolled
Leigh R. Hochberg, MD, PhD.Lead Sponsor
3 Previous Clinical Trials
31 Total Patients Enrolled
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
361 Previous Clinical Trials
182,056 Total Patients Enrolled
Brown UniversityOTHER
466 Previous Clinical Trials
699,078 Total Patients Enrolled
Leigh R Hochberg, MD, Ph.D.Principal InvestigatorMassachusetts General Hospital
~1 spots leftby Jul 2026
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