Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

Not Applicable

Recruiting

• Conditions: Spinal Cord Injuries; Dysarthria; Tetraplegia; Amyotrophic Lateral Sclerosis; Brain Stem Infarctions; Anarthria; Locked in Syndrome; Muscular Dystrophies
• Interventions: Device: BrainGate Neural Interface System

• Registration Number: NCT05724173
• Lead Sponsor: Leigh R. Hochberg, MD, PhD.

Brief 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.

Study Timeline

• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-02-01
• Study First Posted: 2023-02-13
• Study Start: 2023-10-18
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02
• Primary Completion: 2026-07
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BrainGate Neural Interface System	BrainGate Neural Interface System	Placement of the BrainGate2 sensor(s) into the speech-related cortex

Primary Outcome Measures

Name	Time	Method
Device Safety	1 year	To determine the safety of the Sensor and overall safety of the System. Participants will be considered a success for this safety measure if they are successfully implanted with the Sensor(s) and: 1. the sensors are not explanted for safety reasons during the one-year post-implant evaluation period.; 2. there are no device-related Serious Adverse Events that result in death or permanently increased disability during the one-year post-implant evaluation period.

Secondary Outcome Measures

Name	Time	Method
Device Feasibility	At participant exit from study, or up to 5 years	The purpose of this feasibility measure is to define the metrics by which a larger trial of intracortical recording for the restoration of speech-based communication might be planned.; The secondary endpoints are: Number of participants that are able to use the BrainGate system to communicate via speech decoding: 1. at a rate of at least 5 words per minute and; 2. with less than a median word error rate of 50%.

Trial Locations

Locations (2)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States