Brainstem StrokeBG-Tablet-01NCT06511934
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
A study testing BrainGate Neural Interface System in people with Brainstem Stroke and ALS, run by Leigh R. Hochberg, MD, PhD. at 1 site in United States.
Trial summary
People with brainstem stroke, advanced amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), or other disorders can become unable to move or speak despite being awake and alert. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brainstem Stroke, ALS, 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
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2024to 30 Jul 2028
- 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)
- Must live within a three-hour drive of the Study site
- 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, 1 recruiting
- Recruiting
Masssachusetts General Hospital
Boston, Massachusetts, 02114
Leigh R Hochberg, MD, PhD, 617-724-9247, clinicaltrials@braingate.org
About this study
Official title: Intuitive, Complete Neural Control of Tablet Computers for Communication
People with brainstem stroke, advanced amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), or other disorders can become unable to move or speak despite being awake and alert. In this project, the investigators seek to further translate knowledge about interpreting brain signals related to movement, and to further develop an intracortical brain-computer interface (iBCI) that could restore rapid and intuitive use of communication apps on tablet computers by people with paralysis.
Read the detailed description
The goal of this project is to advance the methods by which people with tetraplegia can gain intuitive, reliable control of communication apps on industry-standard tablet computers through use of an intracortical brain-computer interface (iBCI).
- Being tested
- BrainGate Neural Interface System
- Medical subject headings
- Brain Stem Infarctions, Quadriplegia, Spinal Cord Injuries
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 arm-hand motor-related cortex.
| 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 posted22 Jul 2024
- Study start22 Jul 2024
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brainstem StrokeStudies 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
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leigh R. Hochberg, MD, PhD.
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, Stanford University, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor-investigator, Leigh R. Hochberg, MD, PhD., Massachusetts General Hospital
- Investigators
- Leigh R Hochberg, MD, Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511934
- Sponsor's protocol ID
- 2009P000505 (BG-Tablet-01)
- Other IDs
- U01DC017844
- Acronym
- BG-Tablet-01
- Status last verified
- Oct 2026
- First submitted
- 8 Jul 2024
- Last updated
- 26 Oct 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intuitive, Complete Neural Control of Tablet Computers for Communication
- ClinicalTrials.gov ID
- NCT06511934
- Acronym / sponsor ID
- BG-Tablet-01 / 2009P000505 (BG-Tablet-01)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Leigh R. Hochberg, MD, PhD.University, hospital or other
- Collaborators
- Brown University, Stanford University, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 22 Jul 2024 (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.
People with brainstem stroke, advanced amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), or other disorders can become unable to move or speak despite being awake and alert. In this project, the investigators seek to further translate knowledge about interpreting brain signals related to movement, and to further develop an intracortical brain-computer interface (iBCI) that could restore rapid and intuitive use of communication apps on tablet computers by people with paralysis.
Detailed description
The goal of this project is to advance the methods by which people with tetraplegia can gain intuitive, reliable control of communication apps on industry-standard tablet computers through use of an intracortical brain-computer interface (iBCI).
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 (4 listed)
- 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
- 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) into arm-hand motor-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.
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 26 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Leigh R Hochberg, MD, Ph.D. principal investigator
Massachusetts General Hospital
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 Brainstem Stroke 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 4 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 26 Oct 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, MD, 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 26 Oct 2026.