If you are a candidate for neurostimulation, you will have the opportunity to try the therapy during a temporary evaluation period, or trial, for about three to seven days. Using a temporary system, you will be able to assess how well the therapy controls your pain throughout the day and during different activities. After the evaluation, you and your doctor will discuss your experience and decide if moving forward with an implanted neurostimulation system is right for you.

The St. Jude Medical Invisible Trial System

The new St. Jude Medical Invisible Trial System is a discreet and familiar, temporary system that lets you evaluate neurostimulation therapy before committing to an implanted system. Like the implanted system, the temporary system consists of three components that are designed to work together to help manage your pain: an external generator, lead(s), and a patient controller.

  1. External Generator
    A small device that sends pulses to a thin wire called a “lead”. The external generator is taped securely to your lower back and easily hides under your clothing so you can go about your day without anyone knowing you have it.
  2. Leads
  3. Thin wires that deliver pulses from the external generator to nerves along the spinal cord. Leads are placed in the area along your spinal column called the epidural space.

  4. Patient Controller
  5. An external, handheld device that lets you adjust your therapy wirelessly. The patient controller for the
    St. Jude Medical Invisible Trial System is an Apple iPod Touch mobile digital device.

    What to Expect During the Evaluation Period
    During the evaluation period, you can continue to perform your usual activities, as recommended by your doctor, so you can assess how well the stimulation relieves your chronic pain. You will, however, have to limit activities that may cause complications toy your leads during your evaluation period. Be sure to talk to your doctor about what activities (including work and hobbies) you should avoid during this time.

    At the end of the evaluation period, your doctor will remove the temporary system. At this time, you and your doctor will discuss your experience with neurostimulation and whether you want to get an implanted system.

    What are some of the risks associated with an evaluation?
    The placement of the leads is a surgical procedure that will expose you to risks, such as infection, swelling, bruising, and the loss of strength or use in an affected limb or muscle group. Be sure to talk to your doctor about the risks associated with the placement of a temporary system.


    Receiving an Implanted System

    If, after the evaluation period, you and your doctor decide that neurostimulation is right for you, you can choose to have a system implanted.

    To receive an implanted neurostimulation system, you must undergo a surgical procedure, which is typically performed in a hospital or day surgery center. Patients often go home the same day. However, some are asked to stay overnight for observation.

    Before you leave the hospital or day surgery center, you will receive instructions from your doctor on how to care for your incisions and what physical activities you should avoid. You will also be shown how to use the programmer to turn the stimulation on and off and to adjust how the stimulation feels.

    Prior to your procedure, your doctor will likely discuss which type of system is right for you based on criteria such as your lifestyle and pain pattern. In general, there are two types of systems:


    Recovery period limitations

    The months following the implant procedure can be an exciting time as patients become familiar with their neurostimulation system, begin to manage their chronic pain, and gradually return to their activities.

    While recovery times for the procedure vary from person to person, most patients who receive an implanted neurostimulation system recover within six to eight weeks. You should always follow your doctor’s instructions regarding restrictions during the recovery period. Listed below are some general restrictions that patients with implanted neurostimulation systems should follow during the first six to eight weeks after receiving their implant:

    • Avoid twisting, bending, stretching, or lifting anything heavier than five pounds until the leads have healed in place. These movements may cause the leads to move and possibly cause an unpleasant sensation.
    • Do not have a medical test or procedure without checking with your doctor first.
      If you have surgical staples, wait until they are removed before recharging your neurostimulator (applies to rechargeable systems only).
    • Within two weeks of the implant procedure, you will likely have a postoperative checkup. At this visit, your doctor will check the incision site. A St. Jude Medical representative will also be present to show you how to use the programmer and, if applicable, the charging unit.
    • Additional Steps
      While adjusting to life with a neurostimulation system, you will probably need to develop some new habits, such as the following, to optimize your system’s life.

      Determine a good charging routine if you have a rechargeable system.
      If you have a rechargeable system, you will need to determine a good charging routine. St. Jude Medical recommends any routine that is convenient and that maintains effective therapy. However, a daily recharge routine can reduce the time it takes to recharge the battery and extend the life of the generator

      Have your settings adjusted when needed.
      Patients commonly need their settings fine-tuned. If you do not experience sufficient pain relief, you will need to call your doctor’s office to schedule a programming session with your St. Jude Medical representative. Your doctor and representative will do their best to adjust your settings to provide improved pain relief.

      After your procedure, you will receive a system user’s guide with a complete list of warnings and precautions for a neurostimulation system. You can also refer to our Important Safety Information page.
      Visit St. Jude Medical’s site for more information: https://www.poweroveryourpain.com/getting/evaluation.