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

Primary Purpose

Anarthria, Dysarthria, Tetraplegia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BrainGate Neural Interface System
Sponsored by
Leigh R. Hochberg, MD, PhD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anarthria

Eligibility Criteria

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

Inclusion Criteria: Participants must have a diagnosis of amyotrophic lateral sclerosis (ALS) as verified by a clinical expert in neurologic diseases. Participants with a diagnosis of ALS with anarthria, or severe dysarthria with decline in the preceding four months. Exclusion Criteria: Between 18 and 80 years of age. The patient must be able to speak understandably or if unable to speak understandably must have one reliable means of communication. Complete or incomplete tetraplegia (quadriplegia) A minimum of twelve months elapsed post-injury and recovery must have plateaued at least 3 months prior to baseline screening. Per clinical opinion, a life expectancy of greater than 6 months. Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment. (There are additional exclusion criteria)

Sites / Locations

  • Stanford University School of MedicineRecruiting
  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

BrainGate Neural Interface System

Arm Description

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

Outcomes

Primary Outcome Measures

Device Safety
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.

Secondary Outcome Measures

Device Feasibility
The purpose of this feasibility measure is to define the metrics by which a larger trial of intracortical recording for the restoration of speech-based communication might be planned. The secondary endpoints are: Number of participants that are able to use the BrainGate system to communicate via speech decoding: at a rate of at least 5 words per minute and with less than a median word error rate of 50%.

Full Information

First Posted
January 12, 2023
Last Updated
August 22, 2023
Sponsor
Leigh R. Hochberg, MD, PhD.
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT05724173
Brief Title
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia
Acronym
BG-Speech-01
Official Title
Single Neuron Population Dynamics in Human Speech Motor Cortex for a Speech Prosthesis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
December 2026 (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)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
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
Anarthria, Dysarthria, Tetraplegia, Spinal Cord Injuries, Amyotrophic Lateral Sclerosis, Brain Stem Infarctions, Locked in Syndrome, Muscular Dystrophies

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
BrainGate Neural Interface System
Arm Type
Other
Arm Description
Placement of the BrainGate2 sensor(s) into the speech-related cortex
Intervention Type
Device
Intervention Name(s)
BrainGate Neural Interface System
Intervention Description
Placement of the BrainGate2 sensor(s) into the speech-related cortex
Primary Outcome Measure Information:
Title
Device Safety
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Device Feasibility
Description
The purpose of this feasibility measure is to define the metrics by which a larger trial of intracortical recording for the restoration of speech-based communication might be planned. The secondary endpoints are: Number of participants that are able to use the BrainGate system to communicate via speech decoding: at a rate of at least 5 words per minute and with less than a median word error rate of 50%.
Time Frame
At participant exit from study, or up to 5 years

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: Participants must have a diagnosis of amyotrophic lateral sclerosis (ALS) as verified by a clinical expert in neurologic diseases. Participants with a diagnosis of ALS with anarthria, or severe dysarthria with decline in the preceding four months. Exclusion Criteria: Between 18 and 80 years of age. The patient must be able to speak understandably or if unable to speak understandably must have one reliable means of communication. Complete or incomplete tetraplegia (quadriplegia) A minimum of twelve months elapsed post-injury and recovery must have plateaued at least 3 months prior to baseline screening. Per clinical opinion, a life expectancy of greater than 6 months. Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment. (There are additional exclusion criteria)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leigh R Hochberg, MD, Ph.D
Phone
617-724-9247
Email
lhochberg@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jaimie Henderson, MD
Phone
650-723-5574
Email
henderj@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaimie Henderson, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
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
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.
First Name & Middle Initial & Last Name & Degree
Daniel B Rubin, M.D., Ph.D.

12. IPD Sharing Statement

Learn more about this trial

Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

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