Actively Recruiting
Understanding and Restoring Speech Production Using an Intracortical Brain-computer Interface
Led by Leigh R. Hochberg, MD, PhD. · Updated on 2025-12-01
2
Participants Needed
1
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 exploring how to improve communication for people who have lost the ability to speak fluently due to neurological conditions like ALS, stroke, or spinal cord injuries. This study focuses on developing and testing a medical device called an intracortical brain-computer interface (iBCI) that measures brain activity related to speech production. The aim is to understand how brain cells work together to generate speech and to translate this understanding into technology that allows users to communicate through a computer by trying to speak. The study involves implanting the BrainGate2 Neural Interface System, a sensor placed in the speech-related area of the brain. This device records brain signals as participants attempt to speak, helping researchers decode intended speech. Participants will have the sensor implanted and monitored over time to evaluate the device's function and safety, including a primary focus on keeping the implant for at least one year without serious device-related adverse events. During the study, participants will be closely followed to assess the accuracy of the decoded speech from the brain signals, with evaluations continuing up to five years or until the participant exits the study. Researchers will monitor device safety, participant health, and functional outcomes through regular assessments. The total duration of participation varies, with long-term follow-up to understand both device performance and participant experience.
CONDITIONS
Brief Title
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 80 years of age
- 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 and be geographically stable for at least 15 months after enrollment
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 diseases or disorders that could seriously affect ability to participate in the study
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 - Not specified
Participants undergo placement of the BrainGate2 sensor(s) into the speech-related cortex.
1 surgical procedure visit and several follow-up visits for device monitoring
Duration - Up to 5 years
Participants are monitored for at least one year to assess device safety and decoded speech output accuracy.
Regular visits over the monitoring period
Trial Site Locations
Total: 1 location
1
University of California, Davis
Sacramento, California, United States, 95817
Actively Recruiting
Research Team
L
Leigh R. Hochberg, M.D., Ph.D.
S
Sergey Stavisky, Ph.D.
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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