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RecruitingNot ApplicableNCT05724173

Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

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

Sponsor

Leigh R. Hochberg, MD, PhD.

Enrollment

3 participants

Start Date

Oct 18, 2023

Study Type

INTERVENTIONAL

Conditions

AnarthriaAmyotrophic Lateral SclerosisSpinal Cord InjuriesDysarthrialocked-in SyndromeMuscular DystrophiesBrain Stem Infarctionstetraplegia

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria3

  • 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

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Interventions

DEVICEBrainGate Neural Interface System

Placement of the BrainGate2 sensor(s) into the speech-related cortex

Locations(2)

Stanford University School of Medicine

Stanford, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT05724173

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