AnarthriaBG-Speech-02NCT06094205
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)
A study testing BrainGate Neural Interface System in people with Anarthria and Dysarthria, run by Leigh R. Hochberg, MD, PhD. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anarthria, Dysarthria, Tetraplegia
- What is being tested?
- BrainGate Neural Interface System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2023to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 80 years of age
- 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 and geographically stable for at least 15 months after enrollment.
- (There are additional inclusion criteria)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, Davis
Sacramento, California, 95817
David M Brandman, M.D., 916-703-5010, dmbrandman@ucdavis.edu
Sergey Stavisky, Ph.D, 530-754-3413, sstavisky@ucdavis.edu
About this study
Official title: Understanding and Restoring Speech Production Using an Intracortical Brain-computer Interface
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.
Read the 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.
- Conditions
- Anarthria, Dysarthria, Tetraplegia, Spinal Cord Injuries, Amyotrophic Lateral Sclerosis, Brain Stem Infarctions
- Being tested
- BrainGate Neural Interface System
- Medical subject headings
- Dysarthria, Quadriplegia, Spinal Cord Injuries, Amyotrophic Lateral Sclerosis, Brain Stem Infarctions, Locked-In Syndrome, Muscular Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrainGate Neural Interface SystemDevice
Placement of the BrainGate2 sensor(s) into the speech-related cortex
| Study group | Role | What they receive |
|---|---|---|
| BrainGate Neural Interface System | Experimental | Placement of the BrainGate2 sensor(s) into the speech-related cortex Receives: Device: BrainGate Neural Interface System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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
Measured: At participant exit from study, or up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start16 Oct 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnarthriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leigh R. Hochberg, MD, PhD.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor-investigator, Leigh R. Hochberg, MD, PhD., Massachusetts General Hospital
- Investigators
- Sergey Stavisky, Ph.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094205
- Sponsor's protocol ID
- 2009p000505 (BG-Speech-02)
- Other IDs
- 1DP2DC021055
- Acronym
- BG-Speech-02
- Status last verified
- Nov 2025
- First submitted
- 18 Sep 2023
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Restoring Speech Production Using an Intracortical Brain-computer Interface
- ClinicalTrials.gov ID
- NCT06094205
- Acronym / sponsor ID
- BG-Speech-02 / 2009p000505 (BG-Speech-02)
- Conditions
- Anarthria, Dysarthria, Tetraplegia, Spinal Cord Injuries, Amyotrophic Lateral Sclerosis, Brain Stem Infarctions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Leigh R. Hochberg, MD, PhD.University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BrainGate Neural Interface System | Experimental | Device: BrainGate Neural Interface SystemPlacement of the BrainGate2 sensor(s) into the speech-related cortex |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Between 18 and 80 years of age
- 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 and geographically stable for at least 15 months after enrollment.
- (There are additional inclusion criteria)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrainGate Neural Interface SystemPlacement of the BrainGate2 sensor(s) into the speech-related cortex | Device | BrainGate Neural Interface System |
Primary outcome
Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant
Time frame: 1 year
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: 1. the sensors are not explanted for safety reasons during the one-year post-implant evaluation period. 2. there are no device-related Serious Adverse Events that result in death or permanently increased disability during the one-year post-implant evaluation period.
1 secondary outcome
Decoded speech output accuracy
Time frame: At participant exit from study, or up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
Related trials for Anarthria
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia
Anarthria, Dysarthria
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sergey Stavisky, Ph.D. principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BrainGate Neural Interface System in people with Anarthria and Dysarthria, run by Leigh R. Hochberg, MD, PhD. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leigh R. Hochberg, M.D., Ph.D. (617-724-9247, lhochberg@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.