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  • I am In The Clinical Research Study for the New Restore Neurostimulator

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    Old 05-11-2005, 10:16 PM   #1
    bryan25503
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    Exclamation I am In The Clinical Research Study for the New Restore Neurostimulator

    My PM doctor asked me about having a Neurostimulator put in for my low back and leg pain and I told him I wanted to have it done, so I went back in today because its been 45 days and they have not scheduled it yet, so when I went in today he asked me if I wanted to be in the New Clinical Research Study for the New Restore Neurostimulator called "The Restore System" he said the FDA just approved it and it has 2 leads with extensions so it can cover more areas where pain is, He said they are having 100 patients take part in the study at up to 20 centers in the United States. He gave me the paper work today to look over and this is what it says is THE PURPOSE OF THE STUDY: THE PURPOSE OF THE STUDY IS TO GATHER INFORMATION ABOUT HOW WELL A NEW, INVESTIGATIONAL, IMPLANTABLE SPINAL CORD STIMULATOR WITH A RECHARGABLE BATTERY (THE RESTORE SYSTEM) WORKS TO PROVIDE PARESTHESIA (A MILD TINGLING SENSATION) OVER THE AREAS OF YOUR BODY WHERE YOU HAVE PAIN AND RELIEVE PAIN. A SPINAL CORD STIMULATOR SENDS ELECTRICAL SIGNALS TO THE AREA NEAR THE SPINAL CORD. You also get Compensation for Participation in the study, Payment 1 is $100.00 after the Enrollment Visit, Payment 2 is $100.00 and is paid after the screening results followup, Payment 3 is $100.00 and is paid after the surgery to implant the device, Payment 4 is $100.00 and is paid after the 1 month follow-up visit, Payment 5 is $100.00 and is paid after the 3 month follow up visit, Payment 6 is $100.00 and is paid after the 6 month follow-up visit, Payment 7 is $100.00 and is paid after the 12 month follow-up visit, and Payment 8 is $100.00 and is paid after extra follow-up visit occurs for a grand total of $800.00, but there are risks such as spinal fluid leakage, headaches, swelling, bruising, bleeding, infection, paralysis, serious patient injury or death, system damage, resulting in a loss of or change in symptom control and requiring additional surgery, etc. They told me they would call this friday to set me up an appt. to come in to do a baseline and to do some paper work and to sign the consent form and then they will do the trial on May 24, 2005. I have considered everything and have decided to be in this study done by Medtronic, Inc. Wish me luck. ...Has anyone else been approched by your doctor to be in this study for 1 year? If so I want to hear from you and what you all think about this study?
    Brian

    Last edited by bryan25503; 05-11-2005 at 10:18 PM.

     
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    Old 05-12-2005, 05:41 AM   #2
    Shoreline
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    Re: I am In The Clinical Research Study for the New Restore Neurostimulator

    Hey Bryan, It sounds like a good oportunity. Medtronics makes the spinal cord stimulator most often used that you wanted them to implant or do a trial of in the frst place. The disadvantage of the old system was a single lead limiting areas that can be covered. The scarry list of possible side effects or dangers is the exact same list as the old single lead system. The idea of a rechargbale batery simply means you don't have an old unit to replace every 3-5 years as your battery dies.

    If I was in your shoes and wanted to do a trial of the SCS anyway, why not be part of the trial with the multi lead and rechargable unit, I assume no copays, free follow ups, free evrything and a little cash. You have no more to loose than having the old unit placed and would likely kick yourself in the @$$ for having the old unit implanted if the new on hits the market in the next year. The replacement for the old one will likely be the one their asking you to participate in the trial of.

    This isn't new technology, it's improvent on old and proven tech. Hopefully you will get relief from the trial and be able to participate. Part of medtronics screening process is also a psych eval for all their implanatable devices, Pumps and stims, so don't be concerned or offended if they have you take the MMPI or a shortened version and have a consult with a psychologist as part of the screening. I went through all that with the implant of the pump.

    Docs that don't do the proper screening or don't do the psych eval are more likely to have a higher failure rate so don't feel like they are poking and prodding too much, They just want to make sure they aren't slapping one into someone with a major psych illness where personality #1 gets relief but personalty #2 doesn't Everyone with CP will show signs of depression and anxiety so that won't rule you out. Be honest on the test and your more likely to be aproved because their is a truthfullness gage built into the test. They bascically ask you the same question over and over in round about ways. That's why the MMPI "Minnisota multi phasic personality inventory" is over 600 questions.
    Good luck and let us know how it goes.
    Take care, Dave

    Last edited by Shoreline; 05-12-2005 at 05:46 AM.

     
    Old 05-12-2005, 10:27 PM   #3
    bryan25503
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    Re: I am In The Clinical Research Study for the New Restore Neurostimulator

    Hey Dave,
    I think its a good oportunity for me, and yes I have already had the MMPI "Minnisota multi phasic personality inventory test and seen the psychologist. And you are right there is no copays, and the followups and everything else is free and I make the cash for being in the research study, They called today and want me to come in tommarow May 13 to fill out the paper work and will do the trial on Monday May 16 instead of May 24 because they had a cancellation, wish me luck and I will let you know how it goes.........
    Brian

     
    Old 05-13-2005, 04:37 AM   #4
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    Re: I am In The Clinical Research Study for the New Restore Neurostimulator

    Are they looking for more people ? Any contact info ?

     
    Old 05-13-2005, 02:07 PM   #5
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    Re: I am In The Clinical Research Study for the New Restore Neurostimulator

    Hey Guys, I did some digging to find out more about this neuro stim, it has th contact info shawly iif you want to call medtronics and find out where the trials are being done. Here is some info On Restore, but you do have quite a few choices for neuro stims.

    Introducing the RESTORE™
    Rechargeable Neurostimulation System
    Medtronic, the industry leader with the largest line of implantable pain treatment devices, surpasses current market options with its newest rechargeable neurostimulator.

    The RESTORE Rechargeable Neurostimulator is the longest lasting neurostimulation system (up to nine years) for treating the special needs of high-energy patients suffering from chronic pain.

    The RESTORE Rechargeable Neurostimulator System gives people with chronic pain a new level of flexibility and control. Enhanced features and on-going patient support resources add up to meaningful solutions for prevailing over pain.

    Medtronic – Industry Leader With the most comprehensive line of implantable pain treatment options available, you can count on Medtronic’s reputation for quality and reliability. Backed by unparalleled customer service and educational programs, working with Medtronic gives you a powerful advantage in the care and understanding of pain management therapies.

    I found this in Medtronics press release section
    News Release
    Medtronic Media Contacts:
    Robert Carson, Investor Relations, 763-505-2705
    Kyra Schmitt, Public Relations, 763-505-0237


    Medtronic Begins Study Of New Rechargeable Neurostimulation System For Chronic Pain

    Company's Investigation Restore™ System features rechargeable battery with nine-year life



    MINNEAPOLIS, Feb. 15, 2005 – Researchers recently implanted in the first patient in the United States a new, high-power investigational neurostimulation system being developed by Medtronic, Inc. (NYSE: MDT) for chronic pain patients. The implant launched a nationwide, multi-center study of the Restoreä System, an innovative therapy with features that include a battery life not available with currently approved devices on the market for chronic pain.

    The system’s design allows patients to intermittently recharge the battery by themselves. It also is intended to reduce physician burden by offering multiple program options, and decrease the number of physician visits required to manually program the devices.

    “The medical community welcomes an advance in neurostimulation technology,” said Aaron T. Lloyd, M.D., D.A.B.P.M., the study’s first implanter and medical director, Advanced Pain Medicine clinic, Dallas, Texas. “There are many positive implications for a neurostimulation system with a longer recharge interval period. A sustainable, high-power system could have a noticeable impact on patients’ daily lives, and on the efficiency of physician practices.”

    The first U.S. patient is a woman who has suffered for more than ten years from chronic back and leg pain associated with Failed Back Syndrome – one of the most common forms of chronic pain.


    Good luck, Dave

     
    Old 05-15-2005, 12:25 PM   #6
    mngirl
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    Re: I am In The Clinical Research Study for the New Restore Neurostimulator

    There was just an article on them last week in the paper here in Minnesota, I actually took it into my dr here and that was why I asked if anyone had heard or had one implanted.

    My dr said that they work best for those people with leg or back pain. He said that it may not work for arm pain (for my ulnar nerve) or for my head (occipital nerve). They couldn't even place it right for the occipital nerve.

    But we did talk about an infusion pump (lidocaine) for my arm. I am currently having lidocaine infusions done twice a week - and they very from 2-6 hours a piece. I am also having some bad side effects from the treatments that may outweigh the benefits.

    I am having suppressed breathing, some kidney pain (which just started), and some issues when having treatment (tiredness, chest pressure, raipd heartrate, dizziness).

    Unfortunately, I have tried TONS of medications, none of which have worked. The lidocaine infusions have been the ONLY thing that has helped. That is why I am so leary of giving it up!

    ~Lisa

     
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