Neuronal ensemble control of prosthetic devices by a human with tetraplegia.
Leigh R Hochberg, Mijail D Serruya, Gerhard M Friehs...
https://pubmed.ncbi.nlm.nih.gov/16838014Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID00912041
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
Led by Leigh R. Hochberg, MD, PhD. · Updated on 2026-06-01
27
Participants Needed
6
Research Sites
13 weeks
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 evaluating the BrainGate2 Neural Interface System to understand its safety and feasibility for people with tetraplegia, including those with severe speech impairments. The study aims to develop a medical device that could help individuals with paralysis regain abilities that normally depend on hand movement or speech. The project focuses on people with conditions such as spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis, and other motor neuron disorders. The intervention involves placing up to six small BrainGate2 sensors into the motor-related cortex of the brain, including areas related to speech. These sensors connect to percutaneous pedestals to record neural signals, which are monitored weekly for a year or longer. The study is designed to collect preliminary safety data and demonstrate the ability of participants to control computer cursors and other assistive devices using their thoughts. Participants will be involved in regular neural recordings and evaluations to track the device's safety and functionality over a one-year post-implant period. Researchers will assess the feasibility of the system and gather data to inform larger future studies, including neural decoding methods and success measures. The total participation duration may extend beyond one year, with ongoing monitoring of device performance and participant ability to control assistive technologies.
CONDITIONS
Brief Title
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
Who Can Participate
Age: 18Years - 80Years
All Genders
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
- Age between 18 and 80 years
You will not qualify if you...
- Visual impairment that makes extended viewing of a computer monitor difficult even with corrective lenses
- Chronic oral or intravenous steroids or immunosuppressive therapy
- Other serious disease or disorder 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
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - 1 day
Participants have up to six BrainGate2 sensors placed into the motor-related cortex, connected to percutaneous pedestals.
1 surgical implantation visit (in-person)
Monitoring
Duration - At least 1 year
Participants have neural recordings made at least weekly for a year or more to assess device safety and feasibility.
Weekly visits for at least 1 year
Trial Site Locations
Total: 6 locations
1
University of California, Davis
Sacramento, California, United States, 95817
Actively Recruiting
2
Stanford University School of Medicine
Stanford, California, United States, 94305
Actively Recruiting
3
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
5
Providence VA Medical Center
Providence, Rhode Island, United States, 02908
Actively Recruiting
6
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
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Research Team
L
Leigh R Hochberg, M.D., 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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Published Research Related To This Trial
Assistive technology and robotic control using motor cortex ensemble-based neural interface systems in humans with tetraplegia.
John P Donoghue, Arto Nurmikko, Michael Black...
https://pubmed.ncbi.nlm.nih.gov/17272345Adaptive offset correction for intracortical brain-computer interfaces.
Mark L Homer, Janos A Perge, Michael J Black...
https://pubmed.ncbi.nlm.nih.gov/24196868Reliability of directional information in unsorted spikes and local field potentials recorded in human motor cortex.
János A Perge, Shaomin Zhang, Wasim Q Malik...
https://pubmed.ncbi.nlm.nih.gov/24921388Non-causal spike filtering improves decoding of movement intention for intracortical BCIs.
Nicolas Y Masse, Beata Jarosiewicz, John D Simeral...
https://pubmed.ncbi.nlm.nih.gov/25128256Modulation depth estimation and variable selection in state-space models for neural interfaces.
Wasim Q Malik, Leigh R Hochberg, John P Donoghue...
https://pubmed.ncbi.nlm.nih.gov/25265627Neural population dynamics in human motor cortex during movements in people with ALS.
Chethan Pandarinath, Vikash Gilja, Christine H Blabe...
https://pubmed.ncbi.nlm.nih.gov/26099302Inferring single-trial neural population dynamics using sequential auto-encoders.
Chethan Pandarinath, Daniel J O'Shea, Jasmine Collins...
https://pubmed.ncbi.nlm.nih.gov/30224673A Comparison of Intention Estimation Methods for Decoder Calibration in Intracortical Brain-Computer Interfaces.
Francis R Willett, Brian A Murphy, Daniel R Young...
https://pubmed.ncbi.nlm.nih.gov/29989927Robust Closed-Loop Control of a Cursor in a Person with Tetraplegia using Gaussian Process Regression.
David M Brandman, Michael C Burkhart, Jessica Kelemen...
https://pubmed.ncbi.nlm.nih.gov/30216140