Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

Description

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

Anarthria, Dysarthria, Tetraplegia, Spinal Cord Injuries, Amyotrophic Lateral Sclerosis, Brain Stem Infarctions, Locked in Syndrome, Muscular Dystrophies

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Study Overview

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Study Details

Study overview

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.

Single Neuron Population Dynamics in Human Speech Motor Cortex for a Speech Prosthesis

Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

Condition
Anarthria
Intervention / Treatment

-

Contacts and Locations

Stanford

Stanford University School of Medicine, Stanford, California, United States, 94305

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Between 18 and 80 years of age.
  • * Participants must have a diagnosis of amyotrophic lateral sclerosis (ALS) as verified by a clinical expert in neurologic diseases.
  • * Participants with a diagnosis of ALS with anarthria, or severe dysarthria with decline in the preceding four months.
  • * Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.
  • * Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Leigh R. Hochberg, MD, PhD.,

Jaimie Henderson, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

2026-12