Back to resultsFeasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02) (BG-Speech-02)
Primary Purpose
Anarthria, Dysarthria, Tetraplegia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BrainGate Neural Interface System
Sponsored by
About this trial
This is an interventional other trial for Anarthria
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: 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
- University of California, DavisRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BrainGate Neural Interface System
Arm Description
Placement of the BrainGate2 sensor(s) into the speech-related cortex
Outcomes
Primary Outcome Measures
Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant
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
Decoded speech output accuracy
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:
The word error rate of speech that is output by the System
The phoneme error rate of speech that is output by the System
Full Information
NCT ID
NCT06094205
First Posted
September 18, 2023
Last Updated
October 16, 2023
Sponsor
Leigh R. Hochberg, MD, PhD.
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT06094205
Brief Title
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)
Acronym
BG-Speech-02
Official Title
Understanding and Restoring Speech Production Using an Intracortical Brain-computer Interface
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2024 (Anticipated)
Primary Completion Date
August 31, 2027 (Anticipated)
Study Completion Date
August 31, 2027 (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 goal of this study is to improve our understanding of speech production, and to translate this into medical devices called intracortical brain-computer interfaces (iBCIs) that will enable people who have lost the ability to speak fluently to communicate via a computer just by trying to speak.
Detailed Description
The goal is to develop a new way to help people who lose the ability to speak due to neurological conditions including ALS or stroke, using an implanted medical device called a "brain-computer interface". The implanted medical device measures the person's brain activity as they try to talk and outputs their intended speech. By bypassing the injured parts of the nervous system this way, we can observe how individual brain cells are involved in speaking and working together as a network, to produce speech, and we can learn to decipher this activity to output what the person is trying to say.
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
Experimental
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
Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant
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
Decoded speech output accuracy
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:
The word error rate of speech that is output by the System
The phoneme error rate of speech that is output by the System
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:
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:
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, M.D., Ph.D.
Phone
617-724-9247
Email
lhochberg@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sergey Stavisky, Ph.D.
Phone
530-754-3413
Email
sstavisky@ucdavis.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergey Stavisky, Ph.D.
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis
City
Stanford
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, M.D.
Phone
916-703-5010
Email
dmbrandman@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Sergey Stavisky, Ph.D
Phone
530-754-3413
Email
sstavisky@ucdavis.edu
12. IPD Sharing Statement
Learn more about this trial
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)
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