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Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

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

Who can join

Ages 18 to 80 · All sexes

Inclusion 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.

Exclusion Criteria:

* 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

(There are additional exclusion criteria)

About the study

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.

What is being tested

• BrainGate Neural Interface System (device)

Sponsor: Leigh R. Hochberg, MD, PhD. · Participants: 3 · Started: Oct 18, 2023

Contact the study team

• Leigh R Hochberg, MD, Ph.D · Phone: 617-724-9247
• Jaimie Henderson, MD · Phone: 650-723-5574

Official record on ClinicalTrials.gov — NCT05724173

Locations in the U.S.

Conditions

• Dysarthria
• Quadriplegia
• Spinal Cord Injuries
• Amyotrophic Lateral Sclerosis
• Brain Stem Infarctions
• Muscular Dystrophy

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.