Abstract
Some experts at the joint conference questioned whether the Northstarsponsored studies are enrolling human subjects before enough of the basic science research has been completed. Mark Huang,MD,anattendingphysicianat the Rehabilitation Institute of Chicago and investigator for the second study as well as a phase 3 cortical stimulation study that currently is enrolling 174 patients at up to 18 sites, conceded that a number of variables—stimulation frequency and duration, and whether monopolar or bipolar stimulation produces greater functional improvement—still need to be clarified. “There are some protocols that go forward without all the necessary finetuning being done. You could always argue that we should wait longer to do this,” Huang said. “By the same token, it probably is worthwhile to take a look, with the data that we have, at what the efficacy is.” The major question these trials need to answer, he added, is whether cortical stimulation is clinically relevant. “Is it worth it for patients to go through this?” he asked.
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