Actively Recruiting
Single Neuron Population Dynamics in Human Speech Motor Cortex for a Speech Prosthesis Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia
Led by Leigh R. Hochberg, MD, PhD. · Updated on 2026-06-02
3
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
L
Leigh R. Hochberg, MD, PhD.
Lead Sponsor
N
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the BrainGate2 Neural Interface System to evaluate its safety and feasibility in helping people with tetraplegia control computer cursors and other assistive devices using their thoughts. This study aims to explore a medical device that could restore abilities normally relying on hands or speech, especially for those with paralysis and severe speech impairment. The research is led by Leigh R. Hochberg, MD, PhD, focusing on the dynamics of neuron populations in the speech motor cortex. The study involves placing the BrainGate2 sensor into the speech-related cortex of participants. This device is being tested to see how well it can interpret neural signals for communication and control purposes. The intervention period includes device implantation and monitoring to gather data on device safety and functional feasibility over time. Participants will be involved for up to five years, during which safety will be monitored for at least one year and feasibility assessed at study exit or earlier. The study includes assessments of device function, participant ability to control devices via neural signals, and ongoing health evaluations. This long-term involvement helps researchers understand how the device performs and its potential in real-world use for people with severe paralysis.
CONDITIONS
Brief Title
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 80 years of age.
- Diagnosis of amyotrophic lateral sclerosis (ALS) confirmed by a clinical neurologic expert.
- Presence of anarthria or severe dysarthria with decline in the preceding four months.
- Must live within a three-hour drive of the study site and be geographically stable for at least 15 months after enrollment.
You will not qualify if you...
- Visual impairment making extended computer monitor viewing difficult even with corrective lenses.
- Use of chronic oral or intravenous steroids or immunosuppressive therapy.
- Presence of other serious diseases or disorders that could seriously affect ability to participate.
- Additional exclusion criteria not specified 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 day
Participants undergo placement of the BrainGate2 sensor(s) into the speech-related cortex.
1 visit (in-person)
Duration - Up to 5 years
Participants are monitored for device safety and feasibility following sensor placement.
Regular visits scheduled over 1 year and up to 5 years as needed
Trial Site Locations
Total: 2 locations
1
Stanford University School of Medicine
Stanford, California, United States, 94305
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
L
Leigh R Hochberg, MD, Ph.D
J
Jaimie Henderson, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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