Actively Recruiting
Intuitive, Complete Neural Control of Tablet Computers for Communication in People with Tetraplegia Using the BrainGate Neural Interface System
Led by Leigh R. Hochberg, MD, PhD. · Updated on 2025-12-01
2
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
L
Leigh R. Hochberg, MD, PhD.
Lead Sponsor
B
Brown University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are exploring ways to help people with tetraplegia, including those affected by brainstem stroke, advanced amyotrophic lateral sclerosis (ALS), and other motor neuron disorders, to communicate more easily. This study evaluates the use of an intracortical brain-computer interface (iBCI) called the BrainGate Neural Interface System to enable rapid and intuitive control of communication apps on standard tablet computers. The goal is to improve communication for individuals who are awake and alert but unable to move or speak. The study involves implanting the BrainGate2 sensor into the part of the brain that controls arm and hand movement. Participants will use this device to interact with tablet computers, aiming for intuitive and reliable control of communication applications. The BrainGate Neural Interface System is the only intervention being studied, and the sensor's safety and functionality will be monitored over time. Participants will be involved for at least one year, during which researchers will assess how long the sensor can remain implanted without causing serious device-related adverse events or requiring removal. Evaluations will include monitoring safety, device performance, and participant ability to use communication apps. This study is led by Dr. Leigh R. Hochberg and aims to advance brain-computer interface technology for people with severe paralysis.
CONDITIONS
Brief Title
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis, or other motor neuron disorders
- Complete or incomplete tetraplegia (quadriplegia)
- Must live within a three-hour drive of the study site
- Prior enrollment in BrainGate2 clinical trial (NCT00912041)
You will not qualify if you...
- Visual impairment that makes extended viewing of a computer monitor difficult even with ordinary corrective lenses
- Use of chronic oral or intravenous steroids or immunosuppressive therapy
- Other serious disease or disorder that could seriously affect ability to participate in the study
- Additional exclusion criteria not detailed here
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants undergo placement of the BrainGate2 sensor(s) into the arm-hand motor-related cortex to enable neural control of tablet computers.
Initial surgical implantation visit followed by regular follow-up visits for device monitoring
Trial Site Locations
Total: 1 location
1
Masssachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
L
Leigh R Hochberg, MD, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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