Amyotrophic Lateral Sclerosis, Anarthria, Brain Stem Infarctions, Dysarthria, Locked in Syndrome, Muscular Dystrophies, Spinal Cord Injuries, Tetraplegia
Conditions
Brief 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.
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.
Interventions
Placement of the BrainGate2 sensor(s) into the speech-related cortex
Sponsors
Leigh R. Hochberg, MD, PhD.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Safety | 1 year | To determine the safety of the Sensor and overall safety of the System. Participants will be considered a success for this safety measure if they are successfully implanted with the Sensor(s) and: 1. the sensors are not explanted for safety reasons during the one-year post-implant evaluation period. 2. there are no device-related Serious Adverse Events that result in death or permanently increased disability during the one-year post-implant evaluation period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Feasibility | At participant exit from study, or up to 5 years | The purpose of this feasibility measure is to define the metrics by which a larger trial of intracortical recording for the restoration of speech-based communication might be planned. The secondary endpoints are: Number of participants that are able to use the BrainGate system to communicate via speech decoding: 1. at a rate of at least 5 words per minute and 2. with less than a median word error rate of 50%. |
Countries
United States
Contacts
CONTACTLeigh R Hochberg, MD, Ph.D
CONTACTJaimie Henderson, MD
PRINCIPAL_INVESTIGATORJaimie Henderson, MD
Stanford University
Outcome results
None listed