Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

Last updated: November 27, 2024
Sponsor: Leigh R. Hochberg, MD, PhD.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myasthenia Gravis (Chronic Weakness)

Spinal Cord Injuries

Limb Spasticity

Treatment

BrainGate Neural Interface System

Clinical Study ID

NCT05724173
2022p003220 (BG-Speech-01)
U01DC019430
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Between 18 and 80 years of age.

  • Participants must have a diagnosis of amyotrophic lateral sclerosis (ALS) asverified by a clinical expert in neurologic diseases.

  • Participants with a diagnosis of ALS with anarthria, or severe dysarthria withdecline in the preceding four months.

  • Must be within a three-hour drive of the Study site and geographically stable for atleast 15 months after enrollment.

Exclusion

Exclusion Criteria:

  • Visual impairment such that extended viewing of a computer monitor would bedifficult even with ordinary corrective lenses

  • Chronic oral or intravenous steroids or immunosuppressive therapy

  • Other serious disease or disorder that could seriously affect ability to participatein the study

(There are additional exclusion criteria)

Study Design

Total Participants: 2
Treatment Group(s): 1
Primary Treatment: BrainGate Neural Interface System
Phase:
Study Start date:
October 18, 2023
Estimated Completion Date:
December 31, 2026

Study Description

The goal of the BrainGate2 research and development project is to identify the core methods and features for a medical device that could allow people with paralysis, including severe speech impairment, to recover a host of abilities that normally rely on the hands or on speech.

Connect with a study center

  • Stanford University School of Medicine

    Stanford, California 94305
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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