The Data Safety Monitoring Board (the "DSMB") for BrainsGate's
study examined the effect and safety results in an interim analysis of the
study (BrainsGate was not exposed to these results due to the study being a
blinded study). As a result of the said interim analysis, the DSMB determined
as follows:

1. The measured effect justifies the continuation of the study.
2. There were no safety concerns.
3. In order to maximize the possibility of success in the study, increasing the sample size from 450 to 800-1000 patients is appropriate.