Overview
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.
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.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Between 18 and 80 years of age.
- The patient must be able to speak understandably or if unable to speak understandably must have one reliable means of communication.
- Complete or incomplete tetraplegia (quadriplegia)
- A minimum of twelve months elapsed post-injury and recovery must have plateaued at least 3 months prior to baseline screening.
- Per clinical opinion, a life expectancy of greater than 6 months.
- Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.
(There are additional exclusion criteria)