TetraplegiaBrainGate2NCT00912041
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
A study testing Placement of the BrainGate2 sensor(s) into the motor-related cortex in people with Tetraplegia and Spinal Cord Injuries, run by Leigh R. Hochberg, MD, PhD. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tetraplegia, Spinal Cord Injuries, Amyotrophic Lateral Sclerosis
- What is being tested?
- Placement of the BrainGate2 sensor(s) into the motor-related cortex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 6 sitesUnited States
- Study dates
- May 2009to Dec 2038
- 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
- (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
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Emory University School of Medicine
Atlanta, Georgia, 30322
Yvan Bamps, Ph.D., 404-778-7673, braingate@emory.edu
Nicholas Au Yong, M.D., Ph.D.
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Leigh R Hochberg, MD, PhD, 617-742-9247, lhochberg@mgh.harvard.edu
Leigh R Hochberg, M.D., Ph.D.
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Sameer Sheth, MD, PhD, 832-779-3186, BrainGateStudyBCM@bcm.edu
Sameer Sheth, MD, PhD
- Recruiting
Providence VA Medical Center
Providence, Rhode Island, 02908
Stephen Mernoff, M.D., stephen.mernoff@va.gov
Stephen Mernoff, M.D.
- Recruiting
University of California, Davis
Sacramento, California, 95817
David M Brandman, MD, PhD, 916-703-5010, braingate@ucdavis.edu
David M Brandman, MD, PhD
- Recruiting
Stanford University School of Medicine
Stanford, California, 94305
Jaimie Henderson, M.D., 650-723-5574, henderj@stanford.edu
Jaimie Henderson, M.D.
About this study
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.
Read the 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.
- Conditions
- Tetraplegia, Spinal Cord Injuries, Amyotrophic Lateral Sclerosis, Brain Stem Infarctions, Locked in Syndrome, Muscular Dystrophy
- Being tested
- Placement of the BrainGate2 sensor(s) into the motor-related cortex
- Keywords
- Brain computer interface, Assistive device, Environmental control, Communication device, quadriplegia, tetraplegia
- Medical subject headings
- 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.
Placement of the BrainGate2 sensor(s) into the motor-related cortexDevice
Also called BrainGate, NeuroPort, neural prosthesis, neural prosthetic
Up to six 4x4 mm BrainGate2 sensor(s) are placed into the motor-related cortex (including speech-related areas of cortex), connected to one, two, or three percutaneous pedestals. Neural recordings are made at least weekly for a year or more.
| Study group | Role | What they receive |
|---|---|---|
| BrainGate | Other | BrainGate Neural Interface System Receives: Device: Placement of the BrainGate2 sensor(s) into the motor-related cortex |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System.
Measured: One year post-implant evaluation period
Secondary outcomes (1)
To investigate the feasibility of BrainGate2 and to establish the parameters for a larger clinical study, such as appropriate neural decoding algorithms, sample size, indices of measurement, success criteria, and endpoints.
Measured: Course of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2038 (estimated)
- Study completionDec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for TetraplegiaStudies 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
- 27 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), US Department of Veterans Affairs, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor-investigator, Leigh R. Hochberg, MD, PhD., Massachusetts General Hospital
- Investigators
- Leigh R Hochberg, M.D., Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912041
- Sponsor's protocol ID
- MGH-BG2-TP-001
- Other IDs
- R01DC009899, UH2NS095548, A2295-R, U01NS123101, R01DC014034, U01DC017844, CDMRP-AL220043, A4820-R
- Acronym
- BrainGate2
- Status last verified
- May 2026
- First submitted
- 1 Jun 2009
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Hochberg LR, Serruya MD, Friehs GM, Mukand JA, Saleh M, Caplan AH, Branner A, Chen D, Penn RD, Donoghue JP. Neuronal ensemble control of prosthetic devices by a human with tetraplegia. Nature. 2006 Jul 13;442(7099):164-71. doi: 10.1038/nature04970.
PubMed 16838014Donoghue JP, Nurmikko A, Black M, Hochberg LR. Assistive technology and robotic control using motor cortex ensemble-based neural interface systems in humans with tetraplegia. J Physiol. 2007 Mar 15;579(Pt 3):603-11. doi: 10.1113/jphysiol.2006.127209. Epub 2007 Feb 1.
PubMed 17272345Homer ML, Perge JA, Black MJ, Harrison MT, Cash SS, Hochberg LR. Adaptive offset correction for intracortical brain-computer interfaces. IEEE Trans Neural Syst Rehabil Eng. 2014 Mar;22(2):239-48. doi: 10.1109/TNSRE.2013.2287768.
PubMed 24196868Perge JA, Zhang S, Malik WQ, Homer ML, Cash S, Friehs G, Eskandar EN, Donoghue JP, Hochberg LR. Reliability of directional information in unsorted spikes and local field potentials recorded in human motor cortex. J Neural Eng. 2014 Aug;11(4):046007. doi: 10.1088/1741-2560/11/4/046007. Epub 2014 Jun 12.
PubMed 24921388Masse NY, Jarosiewicz B, Simeral JD, Bacher D, Stavisky SD, Cash SS, Oakley EM, Berhanu E, Eskandar E, Friehs G, Hochberg LR, Donoghue JP. Non-causal spike filtering improves decoding of movement intention for intracortical BCIs. J Neurosci Methods. 2014 Oct 30;236:58-67. doi: 10.1016/j.jneumeth.2014.08.004. Epub 2014 Aug 13.
PubMed 25128256Malik WQ, Hochberg LR, Donoghue JP, Brown EN. Modulation depth estimation and variable selection in state-space models for neural interfaces. IEEE Trans Biomed Eng. 2015 Feb;62(2):570-81. doi: 10.1109/TBME.2014.2360393. Epub 2014 Sep 26.
PubMed 25265627Pandarinath C, Gilja V, Blabe CH, Nuyujukian P, Sarma AA, Sorice BL, Eskandar EN, Hochberg LR, Henderson JM, Shenoy KV. Neural population dynamics in human motor cortex during movements in people with ALS. Elife. 2015 Jun 23;4:e07436. doi: 10.7554/eLife.07436.
PubMed 26099302Pandarinath C, O'Shea DJ, Collins J, Jozefowicz R, Stavisky SD, Kao JC, Trautmann EM, Kaufman MT, Ryu SI, Hochberg LR, Henderson JM, Shenoy KV, Abbott LF, Sussillo D. Inferring single-trial neural population dynamics using sequential auto-encoders. Nat Methods. 2018 Oct;15(10):805-815. doi: 10.1038/s41592-018-0109-9. Epub 2018 Sep 17.
PubMed 30224673Willett FR, Murphy BA, Young DR, Memberg WD, Blabe CH, Pandarinath C, Franco B, Saab J, Walter BL, Sweet JA, Miller JP, Henderson JM, Shenoy KV, Simeral JD, Jarosiewicz B, Hochberg LR, Kirsch RF, Ajiboye AB. A Comparison of Intention Estimation Methods for Decoder Calibration in Intracortical Brain-Computer Interfaces. IEEE Trans Biomed Eng. 2018 Sep;65(9):2066-2078. doi: 10.1109/TBME.2017.2783358. Epub 2017 Dec 14.
PubMed 29989927Brandman DM, Burkhart MC, Kelemen J, Franco B, Harrison MT, Hochberg LR. Robust Closed-Loop Control of a Cursor in a Person with Tetraplegia using Gaussian Process Regression. Neural Comput. 2018 Nov;30(11):2986-3008. doi: 10.1162/neco_a_01129. Epub 2018 Sep 14.
PubMed 30216140Vargas-Irwin CE, Feldman JM, King B, Simeral JD, Sorice BL, Oakley EM, Cash SS, Eskandar EN, Friehs GM, Hochberg LR, Donoghue JP. Watch, Imagine, Attempt: Motor Cortex Single-Unit Activity Reveals Context-Dependent Movement Encoding in Humans With Tetraplegia. Front Hum Neurosci. 2018 Nov 15;12:450. doi: 10.3389/fnhum.2018.00450. eCollection 2018.
PubMed 30524258Willett FR, Avansino DT, Hochberg LR, Henderson JM, Shenoy KV. High-performance brain-to-text communication via handwriting. Nature. 2021 May;593(7858):249-254. doi: 10.1038/s41586-021-03506-2. Epub 2021 May 12.
PubMed 33981047Deo DR, Rezaii P, Hochberg LR, M Okamura A, Shenoy KV, Henderson JM. Effects of Peripheral Haptic Feedback on Intracortical Brain-Computer Interface Control and Associated Sensory Responses in Motor Cortex. IEEE Trans Haptics. 2021 Oct-Dec;14(4):762-775. doi: 10.1109/TOH.2021.3072615. Epub 2021 Dec 17.
PubMed 33844633Simeral JD, Hosman T, Saab J, Flesher SN, Vilela M, Franco B, Kelemen JN, Brandman DM, Ciancibello JG, Rezaii PG, Eskandar EN, Rosler DM, Shenoy KV, Henderson JM, Nurmikko AV, Hochberg LR. Home Use of a Percutaneous Wireless Intracortical Brain-Computer Interface by Individuals With Tetraplegia. IEEE Trans Biomed Eng. 2021 Jul;68(7):2313-2325. doi: 10.1109/TBME.2021.3069119. Epub 2021 Jun 17.
PubMed 33784612Rastogi A, Willett FR, Abreu J, Crowder DC, Murphy BA, Memberg WD, Vargas-Irwin CE, Miller JP, Sweet J, Walter BL, Rezaii PG, Stavisky SD, Hochberg LR, Shenoy KV, Henderson JM, Kirsch RF, Ajiboye AB. The Neural Representation of Force across Grasp Types in Motor Cortex of Humans with Tetraplegia. eNeuro. 2021 Feb 19;8(1):ENEURO.0231-20.2020. doi: 10.1523/ENEURO.0231-20.2020. Print 2021 Jan-Feb.
PubMed 33495242
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
- ClinicalTrials.gov ID
- NCT00912041
- Acronym / sponsor ID
- BrainGate2 / MGH-BG2-TP-001
- Conditions
- Tetraplegia, Spinal Cord Injuries, Amyotrophic Lateral Sclerosis, Brain Stem Infarctions, Locked in Syndrome, Muscular Dystrophy
- Keywords
- Brain computer interface, Assistive device, Environmental control, Communication device, quadriplegia, tetraplegia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Leigh R. Hochberg, MD, PhD.University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), US Department of Veterans Affairs, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- May 2009
- Primary completion
- Sep 2038 (estimated)
- Study completion
- Dec 2038 (estimated)
- First posted
- 3 Jun 2009 (estimated)
- 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 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BrainGate | Other | Device: Placement of the BrainGate2 sensor(s) into the motor-related cortexBrainGate 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
- (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 |
|---|---|---|
| Placement of the BrainGate2 sensor(s) into the motor-related cortexAlso: BrainGate, NeuroPort, neural prosthesis, neural prostheticUp to six 4x4 mm BrainGate2 sensor(s) are placed into the motor-related cortex (including speech-related areas of cortex), connected to one, two, or three percutaneous pedestals. Neural recordings are made at least weekly for a year or more. | Device | BrainGate |
Primary outcome
The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System.
Time frame: One year post-implant evaluation period
1 secondary outcome
To investigate the feasibility of BrainGate2 and to establish the parameters for a larger clinical study, such as appropriate neural decoding algorithms, sample size, indices of measurement, success criteria, and endpoints.
Time frame: Course of the study
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 Jun 2026.
- Background: PubMed 16838014Hochberg LR, Serruya MD, Friehs GM, Mukand JA, Saleh M, Caplan AH, Branner A, Chen D, Penn RD, Donoghue JP. Neuronal ensemble control of prosthetic devices by a human with tetraplegia. Nature. 2006 Jul 13;442(7099):164-71. doi: 10.1038/nature04970.
- Background: PubMed 17272345Donoghue JP, Nurmikko A, Black M, Hochberg LR. Assistive technology and robotic control using motor cortex ensemble-based neural interface systems in humans with tetraplegia. J Physiol. 2007 Mar 15;579(Pt 3):603-11. doi: 10.1113/jphysiol.2006.127209. Epub 2007 Feb 1.
- Background: PubMed 24196868Homer ML, Perge JA, Black MJ, Harrison MT, Cash SS, Hochberg LR. Adaptive offset correction for intracortical brain-computer interfaces. IEEE Trans Neural Syst Rehabil Eng. 2014 Mar;22(2):239-48. doi: 10.1109/TNSRE.2013.2287768.
- Background: PubMed 24921388Perge JA, Zhang S, Malik WQ, Homer ML, Cash S, Friehs G, Eskandar EN, Donoghue JP, Hochberg LR. Reliability of directional information in unsorted spikes and local field potentials recorded in human motor cortex. J Neural Eng. 2014 Aug;11(4):046007. doi: 10.1088/1741-2560/11/4/046007. Epub 2014 Jun 12.
- Background: PubMed 25128256Masse NY, Jarosiewicz B, Simeral JD, Bacher D, Stavisky SD, Cash SS, Oakley EM, Berhanu E, Eskandar E, Friehs G, Hochberg LR, Donoghue JP. Non-causal spike filtering improves decoding of movement intention for intracortical BCIs. J Neurosci Methods. 2014 Oct 30;236:58-67. doi: 10.1016/j.jneumeth.2014.08.004. Epub 2014 Aug 13.
- Background: PubMed 25265627Malik WQ, Hochberg LR, Donoghue JP, Brown EN. Modulation depth estimation and variable selection in state-space models for neural interfaces. IEEE Trans Biomed Eng. 2015 Feb;62(2):570-81. doi: 10.1109/TBME.2014.2360393. Epub 2014 Sep 26.
- Background: PubMed 26099302Pandarinath C, Gilja V, Blabe CH, Nuyujukian P, Sarma AA, Sorice BL, Eskandar EN, Hochberg LR, Henderson JM, Shenoy KV. Neural population dynamics in human motor cortex during movements in people with ALS. Elife. 2015 Jun 23;4:e07436. doi: 10.7554/eLife.07436.
- Background: PubMed 30224673Pandarinath C, O'Shea DJ, Collins J, Jozefowicz R, Stavisky SD, Kao JC, Trautmann EM, Kaufman MT, Ryu SI, Hochberg LR, Henderson JM, Shenoy KV, Abbott LF, Sussillo D. Inferring single-trial neural population dynamics using sequential auto-encoders. Nat Methods. 2018 Oct;15(10):805-815. doi: 10.1038/s41592-018-0109-9. Epub 2018 Sep 17.
- Background: PubMed 29989927Willett FR, Murphy BA, Young DR, Memberg WD, Blabe CH, Pandarinath C, Franco B, Saab J, Walter BL, Sweet JA, Miller JP, Henderson JM, Shenoy KV, Simeral JD, Jarosiewicz B, Hochberg LR, Kirsch RF, Ajiboye AB. A Comparison of Intention Estimation Methods for Decoder Calibration in Intracortical Brain-Computer Interfaces. IEEE Trans Biomed Eng. 2018 Sep;65(9):2066-2078. doi: 10.1109/TBME.2017.2783358. Epub 2017 Dec 14.
- Background: PubMed 30216140Brandman DM, Burkhart MC, Kelemen J, Franco B, Harrison MT, Hochberg LR. Robust Closed-Loop Control of a Cursor in a Person with Tetraplegia using Gaussian Process Regression. Neural Comput. 2018 Nov;30(11):2986-3008. doi: 10.1162/neco_a_01129. Epub 2018 Sep 14.
- Background: PubMed 30524258Vargas-Irwin CE, Feldman JM, King B, Simeral JD, Sorice BL, Oakley EM, Cash SS, Eskandar EN, Friehs GM, Hochberg LR, Donoghue JP. Watch, Imagine, Attempt: Motor Cortex Single-Unit Activity Reveals Context-Dependent Movement Encoding in Humans With Tetraplegia. Front Hum Neurosci. 2018 Nov 15;12:450. doi: 10.3389/fnhum.2018.00450. eCollection 2018.
- Background: PubMed 33981047Willett FR, Avansino DT, Hochberg LR, Henderson JM, Shenoy KV. High-performance brain-to-text communication via handwriting. Nature. 2021 May;593(7858):249-254. doi: 10.1038/s41586-021-03506-2. Epub 2021 May 12.
- Home Page for BrainGate ResearchLink provided by the sponsor.
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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, M.D., Ph.D. principal investigator
Massachusetts General Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of the BrainGate2 sensor(s) into the motor-related cortex in people with Tetraplegia and Spinal Cord Injuries, run by Leigh R. Hochberg, MD, PhD. at 6 sites 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 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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, clinicaltrials@braingate.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System. (time frame: One year post-implant evaluation period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00912041, which also lists 42 linked publications.
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 Jun 2026.