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Neuromodulation Overview

 

What is a Neurostimulator?

Neurostimulators are cardiac pacemakers-like devices used to deliver electrical impulses to the central or peripheral nervous system. Electrodes can be placed in the epidural space for spinal cord stimulation or in the thalamus for deep brain stimulation. In addition, Nervion's IPG system may also be used for urinary incontinence, baroreceptor stimulation (hypertension) or for gastric stimulation related to gastroparesis and morbid obesity.

Neurostimulator devices are constantly being upgraded with the focus being upon less invasive approaches and longer lasting effects. Once a neurostimulator is placed it is important to note that current models will need revisions every 3 to 5 years.

Pain Control using Neurostimulation

Neurostimulation delivers low voltage electrical impulses (stimulation) to a specific target nerve in the spinal cord or peripheral nerve to block the perception of pain. One popular theory, the Gate Control Theory of pain developed by researchers Ronald Melzack and Patrick Wall, theorizes that electrical neurostimulation of nerves activates the body's pain inhibitory system. Therefore, this theory proposes that there is a gate in the spinal cord that controls the transmission of pain signals to the brain which results in pain relief. The theory explains that the body can inhibit these pain signals by “closing the gate" and activating certain non-noxious nerve fibers in the dorsal horn of the spinal cord. The neurostimulation system composed of an IPG and electrodes implanted in the epidural space, activates these pain-inhibiting nerve fibers and suppressing the sensation of pain and replaced with a tingling sensation called paresthesia1,2 in the targeted pain area.

Neurostimulation may be an alternative treatment to surgery for the management of certain chronic pain conditions, including: Failed Back Syndrome, Complex Regional Pain Syndrome, and arachnoiditis.

1Melzack R, Wall PD. Pain mechanisms: A new theory. Science. 1965; 150(699):971-9.

2Shealy CN, Mortimer JT, Reswick JB. Electrical inhibition of pain by stimulation of the dorsal columns: Preliminary clinical report. Anesth Analg. 1967; 46(4):489-91.

Neurostimulation or Neuromodulation Therapy

The objective of neuromodulation is to decrease pain rather than completely eliminate pain. A multitude of scientific information confirms that the therapy is effective when used on carefully selected chronic pain patients. These clinical studies summarize the following therapeutic benefits as follows:

  • An increase in pain relief (a majority of patients may experience at least 50 percent reduction in pain)1,2,3
  • Increase activity levels1,2,3,4
  • Reduction of use of potent pain killer medications2,3,4

Neuromodulation therapy may lead to reduced hospitalizations and surgical procedures, thereby reducing health care costs for the treatment of chronic pain, greater freedom to live a normal life, and improved quality of life.2,3,4

1Burchiel K, et al. Prospective, multicenter study of spinal cord stimulation for relief of chronic back and extremity pain. Spine.1996; 21(23):2786-2794.

2North R, et al. Failed back surgery syndrome: 5-year follow-up after spinal cord stimulator implantation. J Neurosurg.1991; 28 (5): 692-699.

3North R, et al. Spinal cord stimulation for chronic, intractable pain: experience over two decades. J Neurosurg.1993; 32 (3): 384-395.

4Racz G, et al. Percutaneous dorsal column stimulator for chronic pain control. Spine.1989; 14 (1): 1-4.

Implantation Procedures

IPG's may be indicated for spinal cord stimulation to treat intractable pain can be performed as a major neurosurgical procedure with open laminotomy or as a minor surgery with placement of the neurostimulator by an anesthesiologist or surgeon. The extent of local scarring, difficulty of placement and available expertise determines which procedure is to be used.

Stimulation Parameter Adjustments

After a neurostimulator is placed, it can be adjusted for intensity of signal and coverage pattern. Some aspects of this adjustment are left to the patient and some are controlled by the physician. Tiny electrical leads are placed at the end of a wire, which in turn is connected to a generator box that determines signal strength and distribution. The generated signal is sent to the underlying spinal cord and causes mild regional paresthesias that can effectively block intractable pain signals from damaged nerves. Although this can be effective solitary treatment, it is best seen as part of an overall treatment regimen, including pharmacological, psychological and social interventions.


In This Section:

Spinal Cord Stimulation
Deep Brain Stimulation
Gastric Stimulation

 

General Knowledge

Types of Implantable Neurostimulators

There are three (3) types of neurostimulation systems:

  • fully implantable, primary battery powered pulse generator (IPG)
  • fully implantable secondary (rechargeable) battery powered pulse generator
  • radio frequency (RF) powered pulse generator

This systems are similar in that they require at least one implanted lead and an external programmer. They are distinguished from each other by, among other things, the location and type of the battery.

 

Primary Battery Powered IPG

This fully-implantable pulse generator has an internal power supply with an external antenna to switch the device ON/OFF and set the required stimulation parameters. This is less cumbersome but requires replacement usually after 2-4 years.

 

Radio Frequency Powered IPG

Composed of an internal receiver with an external battery. An antenna is placed over the receiver and connected to an external power supply. This radiofrequency generator activates the implanted device, producing stimulation. The battery can then be replaced, thus avoiding IPG replacement.

 

Rechergeable IPG

This type of IPG exhibits an implanted appendix antenna that receives an inductive charge from the external patient programmer charger. The lithium ion rechargeable battery contained within the IPG is recharged by placing the patient programmer charger’s external antenna on the patient’s skin over the implant. The charge duration varies depending on discharge level of the battery. It is anticipated that monthly recharge maintenance of 4-8 hours may be required. The rechargeable power source is expected to last for over 7 years.

 

Stimulation Modes:

Stimulation mode is defined as   the delivery configuration of the stimulation parameters. Examples of stimulation mode follows:

- Continuous Stimulation


 

- Cycling Stimulation (ON/OFF)

- Multi-program

 

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Applied Electrical Neuromodulation