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NCT Number: NCT06511934

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

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.

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Key information

Conditions

Brainstem Stroke ALS Brain Diseases Brain Infarction Brain Ischemia Brain Stem Infarctions Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cervical Spinal Cord Injury Infarction Ischemia Necrosis Nervous System Diseases Neurologic Manifestations Paralysis Pathologic Processes Pathological Conditions, Signs and Symptoms Quadriplegia Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Stroke Tetraplegia Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masssachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Leigh R Hochberg, MD, PhD

CONTACT

[email protected]

617-724-9247

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

BrainGate Neural Interface System

Device

Placement of the BrainGate2 sensor(s) into arm-hand motor-related cortex.

Primary outcomes

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

    Time frame: 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:

    • the sensors are not explanted for safety reasons during the one-year post-implant evaluation period.
    • there are no device-related Serious Adverse Events that result in death or permanently increased disability during the one-year post-implant evaluation period.

Study contacts

Contact information is provided by the study sponsor or research team.

Leigh R Hochberg, MD, Ph.D

CONTACT

[email protected]

617-724-9247

Sponsors and collaborators

Lead sponsor

Leigh R. Hochberg, MD, PhD.

Other

Collaborators

  • Brown University
  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • Stanford University

Registry information

Official study title

Intuitive, Complete Neural Control of Tablet Computers for Communication

Acronym: BG-Tablet-01

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 22, 2024
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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