BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia (BrainGate2)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00912041 |
Recruitment Status
:
Recruiting
First Posted
: June 3, 2009
Last Update Posted
: March 29, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tetraplegia Spinal Cord Injuries Amyotrophic Lateral Sclerosis Brain Stem Infarctions Locked in Syndrome Muscular Dystrophy | Device: Placement of the BrainGate2 sensor(s) into the motor-related cortex | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 15 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia |
Study Start Date : | May 2009 |
Estimated Primary Completion Date : | September 2021 |
Estimated Study Completion Date : | December 2021 |

Arm | Intervention/treatment |
---|---|
BrainGate
BrainGate Neural Interface System
|
Device: Placement of the BrainGate2 sensor(s) into the motor-related cortex
One or two 4x4 mm BrainGate2 sensor(s) are placed into the motor-related cortex, connected to a percutaneous pedestal. Neural recordings are made at least weekly for a year or more.
Other Names:
|
- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912041
Contact: Leigh R Hochberg, M.D., Ph.D. | 617-724-9247 | clinicaltrials@braingate.org |
United States, California | |
Stanford University School of Medicine | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Jaimie Henderson, M.D. 650-723-5574 henderj@stanford.edu | |
Principal Investigator: Jaimie Henderson, M.D. | |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Leigh R Hochberg, MD, PhD 617-742-9247 lhochberg@mgh.harvard.edu | |
Principal Investigator: Leigh R Hochberg, M.D., Ph.D. | |
Sub-Investigator: Sydney S Cash, M.D., Ph.D. | |
Sub-Investigator: Emad Eskandar, M.D. | |
United States, Ohio | |
Case Western Reserve University | Recruiting |
Cleveland, Ohio, United States, 44106 | |
Contact: Benjamin Walter, MD 216-844-8285 Benjamin.Walter@uhhospitals.org | |
Contact: Bolu Ajiboye, PhD 216-368-6814 bolu.ajiboye@case.edu | |
Principal Investigator: Benjamin Walter, MD | |
Sub-Investigator: Jonathan Miller, MD | |
Sub-Investigator: Robert Kirsch, PhD | |
United States, Rhode Island | |
Providence VA Medical Center | Recruiting |
Providence, Rhode Island, United States, 02908 | |
Contact: Stephen Mernoff, M.D. stephen.mernoff@va.gov | |
Principal Investigator: Stephen Mernoff, M.D. | |
Sub-Investigator: Leigh R Hochberg, M.D., Ph.D. |
Principal Investigator: | Leigh R Hochberg, M.D., PH.D. | Massachusetts General Hospital |
Additional Information:
Publications of Results:
Other Publications:
Responsible Party: | Leigh R. Hochberg, MD, PhD., Sponsor-Investigator, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00912041 History of Changes |
Other Study ID Numbers: |
MGH-BG2-TP-001 R01DC009899 ( U.S. NIH Grant/Contract ) 1UH2NS095548 ( U.S. NIH Grant/Contract ) |
First Posted: | June 3, 2009 Key Record Dates |
Last Update Posted: | March 29, 2018 |
Last Verified: | March 2018 |
Keywords provided by Leigh R. Hochberg, MD, PhD., Massachusetts General Hospital:
Brain computer interface Assistive device Environmental control |
Communication device quadriplegia tetraplegia |
Additional relevant MeSH terms:
Motor Neuron Disease Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Metabolic Diseases Muscular Disorders, Atrophic Muscular Diseases Musculoskeletal Diseases Genetic Diseases, Inborn Cerebrovascular Disorders Brain Diseases Vascular Diseases Cardiovascular Diseases |
Infarction Spinal Cord Injuries Amyotrophic Lateral Sclerosis Muscular Dystrophies Quadriplegia Brain Stem Infarctions Ischemia Pathologic Processes Necrosis Trauma, Nervous System Wounds and Injuries TDP-43 Proteinopathies Proteostasis Deficiencies Paralysis Neurologic Manifestations |