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Author Topic: Cyberonics clinical studies  (Read 2173 times)
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NancyB
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« on: April 29, 2011, 01:19:43 PM »

I have a question. At  http://dynamic.cyberonics.com/depression/hcp/AboutVNSandTRD/clinicalstudy.aspx  it is discussing Cyberonics' Pivotal Study Acute Phase-12 week Double Blind, Randomized Study for Depression, and it says 'all of the 235 patients were implanted' and then lists their ages as being 18-80. I'm having a little problem with this. Where exactly did they get this '80' year old, from a nursing home? Is it realistic to think that someone in their 80's is actually going to consider having this surgery, or was this a last resort to fill in the gaps because they were having trouble getting people to agree to this surgery, and these were mandated studies given as part of their Conditional Approval? Was this 80 year old even enough in control of his mental facillities to even agree to such a surgery at this late age? If he wasn't, then wouldn't that have been a violation of the 'Nuremberg Code', the 'Declaration of Helinski', or the 'National Research Act'?
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