FDA lets Paradromics recruit BCI trial participants from anywhere in the US
A protocol change drops the rule that Connect-One participants must live within a four-hour drive of a study site.
On October 26, Paradromics said the FDA approved a protocol amendment for its Connect-One early feasibility study of the Connexus brain-computer interface. The change removes the requirement that participants live within a four-hour drive of a study site. People with severe motor impairment from across the continental US can now be considered. They must still be able to travel to one of the three sites: UC Davis Health, Mass General Brigham or University of Michigan Health. Other eligibility rules are unchanged.
Distance has limited who can join BCI trials. The company says it is working with investigators on how to support long-distance participants, and each site will set up procedures with its review board over the coming months.
Learn more: Clinical trial pathway · Paradromics