Your session is about to expire
← Back to Search
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 belowSelect...
I have paralysis in all four limbs.
Select...
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:Select...
I am not on long-term steroids or drugs that weaken my immune system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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
2,475 Previous Clinical Trials
17,501,958 Total Patients Enrolled
Leigh R. Hochberg, MD, PhD.Lead Sponsor
3 Previous Clinical Trials
19 Total Patients Enrolled
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
354 Previous Clinical Trials
181,730 Total Patients Enrolled
Share this study with friends
Copy Link
Messenger