Almost as soon as we published that very popular post about University of Texas at Dallas researchers' efforts to silence that high-pitched problem known as tinnitus, readers began leaving comments and sending e-mails in which they all asked the same question: How can I participate in the forthcoming human clinical trials? So I asked Emily Martinez, the UTD spokesperson charged with publicizing the efforts of Drs. Michael Kilgard and Dr. Navzer Engineer.
Martinez said trials are actually beginning "in the next few weeks," but, sorry, they'll take place in Belgium. She wasn't sure when they'd move back to the U.S. -- or even where in the U.S. So she put me in touch with Dr. Engineer (whose name, I'll admit, I love saying aloud).
Engineer said they're beginning in Europe for one simple reason: "The approval process for the U.S. Food and Drug Administration takes a long time, as you can imagine, especially compared to that in Europe, where approvals are much faster. We want to see what happens in the first three, five patients in Belgium, then come back to the U.S. and say, 'This is the effect it has on patients with severe tinnitus.' So the time line isn't clear." He hopes to have solid results in human within the year, at which point trials will begin locally.
But if there is a chance of expediting clinical trials on U.S. soil, it rests with the military -- which is particularly interested in the results, given the hundreds of millions spent each year treating returning combat veterans. (Engineer says two groups have expressed deep interest in the tinnitus "cure" since it was announced last week -- soldiers and musicians, no surprise there.) Says Engineer, "We hope this year we can facilitate or strengthen that relationship with the military."
He expects, of course, that the FDA will look at the results "most positively" following trials in Europe. After all, he says, the results have thus far been very promising when tried on rats (who were actually given tinnitus by the researchers, who exposed them to loud sounds before beginning treatment).
"We're pretty excited," Engineer says. "As we saw, it works in rats. The vagus nerve stimulator has few side effects. It's a minimally invasive surgery. The big question is whether it it'll work in patients with severe tinnitus because humans are obviously more complicated than rats. It's a big challenge."