AphasiaBG-Aphasia-02NCT07918768
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
A study testing BrainGate Neural Interface System in people with Aphasia and ALS, run by Leigh R. Hochberg, MD, PhD. at 1 site in United States.
Trial summary
In this study, the investigators aim to continue the development of a brain-computer interface (BCI) to help restore speech for stroke survivors with agrammatic aphasia, a language disorder that affects the ability to speak. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- 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
- 31 Oct 2026to 31 Oct 2032
- 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
- Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis, or other motor neuron disorders
- Complete or incomplete tetraplegia (quadriplegia)
- Prior enrollment in BrainGate2 clinical trial (NCT00912041)
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
University of California, Davis
Sacramento, California, 95817
David M Brandman, M.D., Ph.D., dmbrandman@health.ucdavis.edu
About this study
Official title: Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia
In this study, the investigators aim to continue the development of a brain-computer interface (BCI) to help restore speech for stroke survivors with agrammatic aphasia, a language disorder that affects the ability to speak.
Read the detailed description
One in four adults will have a stroke in their lifetime. When the blood flow to the brain is blocked or reduced, brain cells get deprived of oxygen. This might impact language areas in the brain and lead to aphasia.
The goal of this project is to advance the methods by which people with aphasia can help develop and by using an intracortical brain-computer interface (iBCI) restore communication that may serve as a rehabilitation device.
- Being tested
- BrainGate Neural Interface System
- Keywords
- brain computer interface, BCI, iBCI, aphasia
- Medical subject headings
- Aphasia, Stroke
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) for restoration of speech
| Study group | Role | What they receive |
|---|---|---|
| BrainGate Neural Interface System | Experimental | Device: BrainGate Neural Interface System 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start31 Oct 2026 (estimated)
- Primary completion31 Oct 2031 (estimated)
- Study completion31 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies 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
- Device feasibility
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918768
- Sponsor's protocol ID
- 2026P001792 (BG-Aphasia-02)
- Other IDs
- DP2DC024816
- Acronym
- BG-Aphasia-02
- Status last verified
- Nov 2026
- First submitted
- 27 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia
- ClinicalTrials.gov ID
- NCT07918768
- Acronym / sponsor ID
- BG-Aphasia-02 / 2026P001792 (BG-Aphasia-02)
- Keywords
- brain computer interface, BCI, iBCI, aphasia
- Study type
- Interventional
- Recruitment status
- Not yet 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
- 31 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2031 (estimated)
- Study completion
- 31 Oct 2032 (estimated)
- First posted
- 5 Nov 2026 (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.
In this study, the investigators aim to continue the development of a brain-computer interface (BCI) to help restore speech for stroke survivors with agrammatic aphasia, a language disorder that affects the ability to speak.
Detailed description
One in four adults will have a stroke in their lifetime. When the blood flow to the brain is blocked or reduced, brain cells get deprived of oxygen. This might impact language areas in the brain and lead to aphasia.
The goal of this project is to advance the methods by which people with aphasia can help develop and by using an intracortical brain-computer interface (iBCI) restore communication that may serve as a rehabilitation device.
Study design
- Primary purpose
- Device feasibility
- 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 SystemDevice: BrainGate Neural Interface System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis, or other motor neuron disorders
- Complete or incomplete tetraplegia (quadriplegia)
- Prior enrollment in BrainGate2 clinical trial (NCT00912041)
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) for restoration of speech | 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.
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 5 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Enrolling by invitation
Effects of Semantic Context on Criterion-learning Naming Treatment in Aphasia
Aphasia
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.
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 Aphasia and ALS, 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 3 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: opening soon, as of the sponsor's last update on 5 Nov 2026. 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 5 Nov 2026.