Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)

Not Applicable

Recruiting

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

• Registration Number: NCT06094205
• Lead Sponsor: Leigh R. Hochberg, MD, PhD.

Brief Summary

The goal of this study is to improve our understanding of speech production, and to translate this into medical devices called intracortical brain-computer interfaces (iBCIs) that will enable people who have lost the ability to speak fluently to communicate via a computer just by trying to speak.

Detailed Description

The goal is to develop a new way to help people who lose the ability to speak due to neurological conditions including ALS or stroke, using an implanted medical device called a "brain-computer interface". The implanted medical device measures the person's brain activity as they try to talk and outputs their intended speech. By bypassing the injured parts of the nervous system this way, we can observe how individual brain cells are involved in speaking and working together as a network, to produce speech, and we can learn to decipher this activity to output what the person is trying to say.

Study Timeline

• Study First Submitted: 2023-09-18
• Study Start: 2023-10-16
• Study First Submitted QC: 2023-10-16
• Study First Posted: 2023-10-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

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

Inclusion Criteria

• Between 18 and 80 years of age
• Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders
• Complete or incomplete tetraplegia (quadriplegia)
• Must live within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.

(There are additional inclusion criteria)

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
Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant	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
Decoded speech output accuracy	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: * The word error rate of speech that is output by the System; * The phoneme error rate of speech that is output by the System

Trial Locations

Locations (1)

University of California, Davis; 🇺🇸 Sacramento, California, United States