NCT06094205

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

Understanding and Restoring Speech Production Using an Intracortical Brain-computer Interface

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (estimated)
• Sponsor: Leigh R. Hochberg, MD, PhD. · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anarthria
• Dysarthria
• Tetraplegia
• Spinal Cord Injuries
• Amyotrophic Lateral Sclerosis
• Brain Stem Infarctions
• Locked-in Syndrome
• Muscular Dystrophies

Interventions

Type	Name	Description
DEVICE	BrainGate Neural Interface System	Placement of the BrainGate2 sensor(s) into the speech-related cortex

Timeline

• Start date: 2023-10-16
• Primary completion: 2027-08-31
• Completion: 2027-08-31
• First posted: 2023-10-23
• Last updated: 2025-12-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study