NCT06511934

Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)

Intuitive, Complete Neural Control of Tablet Computers for Communication

• 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

People with brainstem stroke, advanced amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), or other disorders can become unable to move or speak despite being awake and alert. In this project, the investigators seek to further translate knowledge about interpreting brain signals related to movement, and to further develop an intracortical brain-computer interface (iBCI) that could restore rapid and intuitive use of communication apps on tablet computers by people with paralysis.

Detailed description

The goal of this project is to advance the methods by which people with tetraplegia can gain intuitive, reliable control of communication apps on industry-standard tablet computers through use of an intracortical brain-computer interface (iBCI).

Conditions

• Brainstem Stroke
• ALS
• Tetraplegia
• Spinal Cord Injuries
• Cervical Spinal Cord Injury

Interventions

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

Timeline

• Start date: 2024-07-22
• Primary completion: 2026-07-30
• Completion: 2027-07-30
• First posted: 2024-07-22
• Last updated: 2025-12-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study