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

Not Applicable

Recruiting

• Conditions: Cervical Spinal Cord Injury; ALS; Tetraplegia; Spinal Cord Injuries; Brainstem Stroke
• Interventions: Device: BrainGate Neural Interface System

• Registration Number: NCT06511934
• Lead Sponsor: Leigh R. Hochberg, MD, PhD.

Brief 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).

Study Timeline

• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-16
• Study Start: 2024-07-22
• Study First Posted: 2024-07-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02
• Primary Completion: 2026-07-30
• Study Completion: 2027-07-30

Recruitment & Eligibility

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

Inclusion Criteria

• 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
• Prior enrollment in BrainGate2 clinical trial (NCT00912041)

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	Device: BrainGate Neural Interface System

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.

Trial Locations

Locations (1)

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