| June 1, 2009 |
| September 17, 2009 |
| May 2009 |
| September 2015 (final data collection date for 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 ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00912041 on ClinicalTrials.gov Archive Site |
| 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 ] |
| Same as current |
| |
| BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia |
| BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia |
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. |
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. |
| |
| Interventional |
| Other, Open Label, Single Group Assignment, Safety Study |
- Tetraplegia
- Spinal Cord Injuries
- Amyotrophic Lateral Sclerosis
- Brain Stem Infarctions
- Locked In Syndrome
|
| Device: Placement of the BrainGate2 sensor into the motor cortex |
| |
- 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.
- Donoghue 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. Epub 2007 Feb 1. Review.
|
| |
| Recruiting |
| 15 |
| December 2015 |
| September 2015 (final data collection date for primary outcome measure) |
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 two-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)
|
| Both |
| 18 Years to 75 Years |
| No |
|
|
| United States |
| |
| NCT00912041 |
| Leigh R. Hochberg, M.D., Ph.D., Massachusetts General Hospital |
| MGH-BG2-TP-001 |
| Massachusetts General Hospital |
- National Center for Medical Rehabilitation Research
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institute on Deafness and Other Communication Disorders (NIDCD)
|
| Principal Investigator: |
Leigh R Hochberg, M.D., PH.D. |
Massachusetts General Hospital |
|
|
| Massachusetts General Hospital |
| September 2009 |
