Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT05724173

Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

Led by Leigh R. Hochberg, MD, PhD. · Updated on 2025-12-03

3

Participants Needed

2

Research Sites

162 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 purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.

CONDITIONS

Official Title

Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Between 18 and 80 years of age.
  • Diagnosis of amyotrophic lateral sclerosis (ALS) confirmed by a neurologic expert.
  • Severe speech impairment with anarthria or severe dysarthria showing decline in the last four months.
  • Living within a three-hour drive of the study site and able to remain geographically stable for at least 15 months after enrollment.
Not Eligible

You will not qualify if you...

  • Visual impairment that makes viewing a computer monitor difficult, even with corrective lenses.
  • Use of chronic oral or intravenous steroids or immunosuppressive therapy.
  • Presence of other serious diseases or disorders that could severely affect participation.
  • Additional exclusion criteria not specified here.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

L

Leigh R Hochberg, MD, Ph.D

CONTACT

J

Jaimie Henderson, MD

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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