NCT05724173

Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (estimated)
• Sponsor: Leigh R. Hochberg, MD, PhD. · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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: 2023-10-18
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2023-02-13
• Last updated: 2025-12-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study