Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06094205

Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)

Led by Leigh R. Hochberg, MD, PhD. · Updated on 2025-12-01

2

Participants Needed

1

Research Sites

202 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

The goal of this study is to improve our understanding of speech production, and to translate this into medical devices called intracortical brain-computer interfaces (iBCIs) that will enable people who have lost the ability to speak fluently to communicate via a computer just by trying to speak.

CONDITIONS

Official Title

Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Visual impairment that makes extended viewing of a computer monitor difficult even with ordinary corrective lenses
  • Currently on chronic oral or intravenous steroids or immunosuppressive therapy
  • Other serious disease or disorder that could significantly affect the ability to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California, Davis

Sacramento, California, United States, 95817

Actively Recruiting

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Research Team

L

Leigh R. Hochberg, M.D., Ph.D.

CONTACT

S

Sergey Stavisky, Ph.D.

CONTACT

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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