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Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia | Clinical Trials | Clareo Health

RECRUITINGNA

Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

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

NCT05724173•Leigh R. Hochberg, MD, PhD.

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.

Detailed 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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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

Locations (2)

Stanford University School of Medicine

Stanford, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

October 18, 2023

Primary Completion Date

July 1, 2026

Completion Date

December 1, 2026

Last Updated

December 3, 2025

Enrollment

ESTIMATED participants

Conditions

AnarthriaDysarthriaTetraplegiaSpinal Cord InjuriesAmyotrophic Lateral SclerosisBrain Stem InfarctionsLocked in SyndromeMuscular Dystrophies

Interventions

BrainGate Neural Interface System

DEVICE

Contacts

Leigh R Hochberg, MD, Ph.D

CONTACT

617-724-9247 lhochberg@mgh.harvard.edu

Jaimie Henderson, MD

CONTACT

650-723-5574 henderj@stanford.edu

Self-balancing Personal Exoskeleton for SCI (Site 2)

NCT06814015

Spinal Cord Injuries (SCI)Paraplegia and Tetraplegia

View study

RECRUITINGNA

Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)

NCT07357428

Amyotrophic Lateral SclerosisNeuromuscular Disease+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

Inclusion Criteria

Exclusion Criteria

Self-balancing Personal Exoskeleton for SCI (Site 2)

Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)

Cognitive Reserve and Response to Speech-Language Intervention in Bilingual Speakers With Primary Progressive Aphasia

Investigation on the Bidirectional Cortical Neuroprosthetic System

GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices

Control Interfaces for Operating Assistive Devices