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

NCT00912041 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-12-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

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

Up to six 4x4 mm BrainGate2 sensor(s) are placed into the motor-related cortex (including speech-related areas of cortex), connected to one, two, or three percutaneous pedestals. Neural recordings are made at least weekly for a year or more.

Sponsors & Collaborators

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

    collaborator NIH

  • US Department of Veterans Affairs

    collaborator FED

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Leigh R. Hochberg, MD, PhD.

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2038-09-30
Completion
2038-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00912041 on ClinicalTrials.gov