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BrainGate2 System for Tablet Control in Tetraplegia

This study is testing the BrainGate Neural Interface System, a device that helps people with paralysis control communication apps on tablet computers using their thoughts. It involves placing a sensor into the part of the brain that controls arm and hand movement. The goal is to see if the sensor can stay implanted for at least one year without serious problems or needing to be removed. You might be able to join if you are 18 to 80 years old, have complete or incomplete tetraplegia (quadriplegia) due to conditions like a spinal cord injury, brainstem stroke, or ALS, and live within a three-hour drive of the study site. You must also have previously participated in the BrainGate2 clinical trial (NCT00912041). The current status of this study is unclear, and it plans to enroll 6 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 6 participants.
What's involved
Participants will have the BrainGate2 sensor(s) placed into their brain. The primary goal is to see if the sensor can remain implanted for at least one year.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures sensor implant duration for at least one year.

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NCT06511934

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

Recruiting
NAAges 18–80InterventionalDevice feasibility
Leigh R. Hochberg, MD, PhD.
~6 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:BrainGate Neural Interface System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant
Measured over 1 year

Conditions

Brainstem Stroke
ALS
Tetraplegia
Spinal Cord Injuries
Cervical Spinal Cord Injury

Explore related trials

Amyotrophic Lateral SclerosisBrain stem infarctionMotor Neuron DiseaseMuscular DystrophyQuadriplegiaSpinal Cord Injury

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Leigh R Hochberg, MD, Ph.D. · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Leigh R Hochberg, MD, Ph.D
[email protected]
617-724-9247
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant1 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.