BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia (BrainGate2)

February 26, 2024 updated by: Leigh R. Hochberg, MD, PhD.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California, Davis
        • Contact:
        • Principal Investigator:
          • David M Brandman, MD, PhD
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University School of Medicine
        • Contact:
        • Principal Investigator:
          • Jaimie Henderson, M.D.
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University School of Medicine
        • Contact:
        • Principal Investigator:
          • Nicholas Au Yong, M.D., Ph.D.
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Leigh R Hochberg, M.D., Ph.D.
        • Sub-Investigator:
          • Sydney S Cash, M.D., Ph.D.
        • Sub-Investigator:
          • Ziv Williams, M.D., Ph.D.
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
        • Recruiting
        • Providence VA Medical Center
        • Contact:
        • Principal Investigator:
          • Stephen Mernoff, M.D.
        • Sub-Investigator:
          • Leigh R Hochberg, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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
  • (There are additional inclusion criteria)

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: BrainGate
BrainGate Neural Interface System
Device: Placement of the BrainGate2 sensor(s) into the motor-related cortex
Up to four 4x4 mm BrainGate2 sensor(s) are placed into the motor-related cortex (including speech-related areas of cortex), connected to one or two percutaneous pedestals. Neural recordings are made at least weekly for a year or more.
Other Names:
  • neuroprosthetic
  • brain-computer interface
  • NeuroPort
  • BrainGate
  • neural prosthesis
  • neural prosthetic
  • brain computer interface

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System.
Time Frame: One year post-implant evaluation period
One year post-implant evaluation period

Secondary Outcome Measures

Outcome Measure
Time Frame
To investigate the feasibility of BrainGate2 and to establish the parameters for a larger clinical study, such as appropriate neural decoding algorithms, sample size, indices of measurement, success criteria, and endpoints.
Time Frame: Course of the study
Course of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leigh R. Hochberg, MD, PhD.

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)
US Department of Veterans Affairs
National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Leigh R Hochberg, M.D., Ph.D., Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Estimated)

September 1, 2038

Study Completion (Estimated)

December 1, 2038

Study Registration Dates

First Submitted

June 1, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (Estimated)

June 3, 2009

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MGH-BG2-TP-001
  • R01DC009899 (U.S. NIH Grant/Contract)
  • UH2NS095548 (U.S. NIH Grant/Contract)
  • A2295-R (Other Grant/Funding Number: U.S. Department of Veterans Affairs)
  • U01NS123101 (U.S. NIH Grant/Contract)
  • R01DC014034 (U.S. NIH Grant/Contract)
  • U01DC017844 (U.S. NIH Grant/Contract)
  • CDMRP-AL220043 (Other Grant/Funding Number: Department of Defense (DOD))
  • A4820-R (Other Grant/Funding Number: U.S. Department of Veterans Affairs)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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