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

Primary Purpose

Tetraplegia, Spinal Cord Injuries, Amyotrophic Lateral Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placement of the BrainGate2 sensor(s) into the motor-related cortex
Sponsored by
Leigh R. Hochberg, MD, PhD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tetraplegia focused on measuring Brain computer interface, Assistive device, Environmental control, Communication device, quadriplegia, tetraplegia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of California, DavisRecruiting
  • Stanford University School of MedicineRecruiting
  • Emory University School of MedicineRecruiting
  • Massachusetts General HospitalRecruiting
  • Providence VA Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

BrainGate

Arm Description

BrainGate Neural Interface System

Outcomes

Primary Outcome Measures

The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System.

Secondary Outcome Measures

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.

Full Information

First Posted
June 1, 2009
Last Updated
December 31, 2022
Sponsor
Leigh R. Hochberg, MD, PhD.
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), US Department of Veterans Affairs, National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00912041
Brief Title
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
Acronym
BrainGate2
Official Title
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 2009 (undefined)
Primary Completion Date
September 2038 (Anticipated)
Study Completion Date
December 2038 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Leigh R. Hochberg, MD, PhD.
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), US Department of Veterans Affairs, National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetraplegia, Spinal Cord Injuries, Amyotrophic Lateral Sclerosis, Brain Stem Infarctions, Locked in Syndrome, Muscular Dystrophy
Keywords
Brain computer interface, Assistive device, Environmental control, Communication device, quadriplegia, tetraplegia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BrainGate
Arm Type
Other
Arm Description
BrainGate Neural Interface System
Intervention Type
Device
Intervention Name(s)
Placement of the BrainGate2 sensor(s) into the motor-related cortex
Other Intervention Name(s)
BrainGate, NeuroPort, neural prosthesis, neural prosthetic, neuroprosthetic, brain computer interface, brain-computer interface
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leigh R Hochberg, M.D., Ph.D.
Phone
617-724-9247
Email
clinicaltrials@braingate.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leigh R Hochberg, M.D., Ph.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David M Brandman, MD, PhD
Phone
916-703-5010
Email
braingate@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
David M Brandman, MD, PhD
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaimie Henderson, M.D.
Phone
650-723-5574
Email
henderj@stanford.edu
First Name & Middle Initial & Last Name & Degree
Jaimie Henderson, M.D.
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yvan Bamps, Ph.D.
Phone
404-778-7673
Email
braingate@emory.edu
First Name & Middle Initial & Last Name & Degree
Nicholas Au Yong, M.D., Ph.D.
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leigh R Hochberg, MD, PhD
Phone
617-742-9247
Email
lhochberg@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Leigh R Hochberg, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Sydney S Cash, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Ziv Williams, M.D., Ph.D.
Facility Name
Providence VA Medical Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Mernoff, M.D.
Email
stephen.mernoff@va.gov
First Name & Middle Initial & Last Name & Degree
Stephen Mernoff, M.D.
First Name & Middle Initial & Last Name & Degree
Leigh R Hochberg, M.D., Ph.D.

12. IPD Sharing Statement

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Links:
URL
http://www.braingate.org
Description
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BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia

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