How Long Will it Take rTMS to Gain FDA Approval

Ask the Expert Patient Health Guide
  • Question:

     

    mn6902 wrote...

     

    rTMS and FDA approval?

     

    Does anyone know the current status of FDA approval of rTMS (repetitive transcranial magnetic stimulation) for depression treatment in the USA? It has been offered in many developed countries around the world for several years. Why must we be the last?

     

     

    Answer:

     

    Dear mn6902,

     

    All the information I can find indicates that deep brain stimulation has been FDA approved for Parkinson's and essential tremor, but is still in clinical trials for depression. Check out this article from the Cleveland Clinic, "Deep Brain Stimulation for OCD and Depression."

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    If you'd like to see if there are any clinical trials in your area, take a look at our clinical trials information page.

     

    Are you sure it's available in other countries for several years for depression? Usually, with the exception of some parts of Europe, the U.S. approval of treatments is earlier than most other countries, including Canada.

     

    Clinical trials do take quite some time in the U.S. The criteria and methods for the trials have to be approved by the FDA before study participants can be enrolled. The enrollment period can take time, depending on the responsiveness of patients in enrolling. Even after the trial data is collected and analyzed by the researchers, there's the time for the FDA to review it. You probably know all of that already. It is extremely frustrating waiting for new treatments to be approved. On the other hand, in the U.S., lawyers and patients have become quite quick to sue the companies that develop treatments if unexpected or long-term effects arise later on. That certainly doesn't speed up the process.

     

    Good luck,

     

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Published On: October 15, 2007