Boston-Scientific Vercise - Intrepid Study

[vivace1017]

Is there anyone on this site who is in the Boston Scientific Intrepid study? I had the brain implants done on October 15 and the computer module implant on November 7. The device was turned on four weeks ago, and I'm fairly certain I am in the 25% of patients who are receiving the low, intermittent dose. I'm wondering about others who are in the study and what your experiences are.

[froggatt55]

Can you tell me more about this trial /study please?

[vivace1017 in reply to froggatt55]

Hi,

Boston-Scientific has a DBS Device already approved and being used in Europe and Australia. It is called the Vercise system and is designed specifically for the brain. This is a much higher end technology than the Medtronic device currently approved for use in the USA. The company is now working towards US approval via a 5 year study. If you look at their company website and click on the Vercise Intrepid study, you can learn more about it.

Basically, a patient has to meet a fairly narrow set of parameters to qualify for the study. If one qualifies, then surgeons implant the electrodes in the brain ( a long, patient-awake surgery!) and then, about three weeks later, they implant the computer module in the patient's shoulder. After a few weeks to heal, the device is turned on, but for the first 12 weeks, it is NOT optimized for the individual patient. Rather, participants are randomized into one of two study groups that receive the same dose of stimulation for 12 weeks. There is extensive testing as part of the entire process.

It is a LONG process, but the upside is that once the implant is done, you have the top-of-the-line device.....for life! Hopefully, in five years, it will be approved for regular use by Parkinson's folks.

[froggatt55 in reply to vivace1017]

Hi Vivace1017 - thanks for this - it is very interesting and I shall now review it on Google!

Suggest you google GDNF Trial, Parkinson' Bristol