Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia
Purpose
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.
Conditions
- Anarthria
- Dysarthria
- Tetraplegia
- Spinal Cord Injuries
- Amyotrophic Lateral Sclerosis
- Brain Stem Infarctions
- Locked in Syndrome
- Muscular Dystrophies
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Between 18 and 80 years of age. - Participants must have a diagnosis of amyotrophic lateral sclerosis (ALS) as verified by a clinical expert in neurologic diseases. - Participants with a diagnosis of ALS with anarthria, or severe dysarthria with decline in the preceding four months. - Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.
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)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Other BrainGate Neural Interface System |
Placement of the BrainGate2 sensor(s) into the speech-related cortex |
|
Recruiting Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Leigh R. Hochberg, MD, PhD.
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.