BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia (BrainGate2)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified September 2016 by Massachusetts General Hospital
Sponsor:
Leigh R. Hochberg, MD, PhD.
Collaborators:
National Center for Medical Rehabilitation Research (NCMRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
VA Office of Research and Development
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Leigh R. Hochberg, MD, PhD., Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00912041
First received: June 1, 2009
Last updated: September 12, 2016
Last verified: September 2016
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Purpose
The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility of efficacy) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.
| Condition | Intervention |
|---|---|
|
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 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia |
Resource links provided by NLM:
Genetics Home Reference related topics:
amyotrophic lateral sclerosis
Genetic and Rare Diseases Information Center resources:
Muscular Dystrophy
Amyotrophic Lateral Sclerosis
Locked-in Syndrome
U.S. FDA Resources
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 15 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | December 2021 |
| Estimated Primary Completion Date: | September 2021 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
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 to recover a host of abilities that normally rely on the hands.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912041
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912041
Contacts
| Contact: Leigh R Hochberg, M.D., Ph.D. | 617-724-9247 | clinicaltrials@braingate.org |
Locations
| 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 | |
| Principal Investigator: Leigh R Hochberg, M.D., Ph.D. | |
| Sub-Investigator: Sydney S Cash, M.D., Ph.D. | |
| Sub-Investigator: Merit E Cudkowicz, M.D., M.Sc. | |
| 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. | |
Sponsors and Collaborators
Leigh R. Hochberg, MD, PhD.
National Center for Medical Rehabilitation Research (NCMRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
VA Office of Research and Development
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
| Principal Investigator: | Leigh R Hochberg, M.D., PH.D. | Massachusetts General Hospital |
More Information
Additional Information:
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 RC1HD063931 R01HD077220 1UH2NS095548 |
| Study First Received: | June 1, 2009 |
| Last Updated: | September 12, 2016 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on September 26, 2016