Patient Site

The term "neuromodulation" encompasses a broad array of treatments, both electrical and chemical, targeting a variety of locations in the body to best achieve the desired outcome. Some of the more frequently used techniques are described in detail below.

10 Things to Know About Neuromodulation Minimally Invasive Procedures to Reduce or Alleviate Pain
NEW YORK – February 24, 2010 – Robert Foreman, Ph.D., president of the North American Neuromodulation Society (NANS), stated, “Neuromodulation is among the most rapidly growing fields in medicine today. It can help to relieve chronic back pain, pain from cancer and other nerve injuries, pain from Complex Regional Pain Syndrome (CRPS) and Reflex Sympathetic Dystrophy (RSD) greatly improving the quality of life for patients.”

Neuromodulation encompasses the application of targeted electrical, chemical and biological technologies to the nervous system in order to improve function and quality of life. The appropriate therapy (low level electrical pulses or micro-doses of medicine) are targeted to nerves along the spinal cord to block pain signals to the brain.

According to Joshua Prager, MD, MS, former president of NANS, “Neuromodulation can give people their lives back. Patients have gone from wheelchairs back to the tennis court, back to the sidelines of their children’s soccer games, back to their jobs. There are few treatments that can improve the activity level and the psychological outlook of a patient in pain like neuromodulation techniques.” NANS has compiled ten things everyone should know about neuromodulation:

• 1. Neuromodulation alleviates or lessens pain without putting patients into a “drug fog.” By relieving pain with neuro-stimulation or a drug-delivery system, that provides micro-doses of medicine, the patient can avoid some side effects, including excessive sedation or clouding of thoughts.


• 2. Potential neuromodulation patients can “test drive” the modality. Neuromodulation is administered via minimally invasive techniques and it is a rare medical treatment that the patient can “test drive” during an incisionless trial before final consideration of the device’s insertion.


• 3. Neuromodulation is FDA approved and has been used in practice for two decades. Extensive research and clinical trials have documented neuromodulation’s ability to decrease chronic pain and improve the quality of life for patients.


• 4. Neuromodulation can be applied through different techniques. Neuromodulation comprises four treatment modalities: spinal cord stimulation, spinal drug delivery systems, brain stimulation and peripheral nerve stimulation. These treatments should only be administered or provided by a trained Physician who specializes in this type of care.


• 5. Neuromodulation implants can be removed. Once implemented, if the patient chooses to stop the treatment, the device can be removed. The procedure is reversible.


• 6. Neuromodulation improves the quality of life for patients in pain. The American Pain Foundation estimates that chronic pain affects 76.5 million people in the U.S., while the National Institutes of Health estimates that chronic pain costs the U.S. economy $100 billion a year in lost work time and medical expenses.
  
  Therapeutic Effectiveness
  
  • In a national registry of patients with low back pain, implanted with an intrathecal drug deliver (IDD) system: At the 6 and 12 month follow-up evaluations, pain scores had decreased significantly both for back and leg pain compared to baseline. At 12 months, back pain had declined by 48% and leg pain by 32%.
    At 6 and 12 months, improvements in functional abilities had occurred in 60% and 65% of the patients.
    Deer T, et al. Pain Med 2004
  
  
  • According to a study conducted by North et al. in 2005, 47% of patients who received Spinal Cord Stimulation (SCS) found that it relieved their pain by 50% or more; this is significantly more than the 12% who achieved the same effect through reoperation.
    North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. 2005;56:98-106; discussion 106-107.
  
  
  • Back pain accounted for 40% of absences from work, second only to the common cold. Guo HR, Tanaka S, Halperin WE, Cameron LL. Back pain prevalence in US industry and estimates of lost workdays. Am J Public Health. 1999;89:1029-1035.
  
  
  • Recent systematic reviews of many trials with thousands of patients also verify the benefits of SCS. A 2005 review of 74 studies of 3300 patients with chronic leg and back pain and FBSS found that:
    62% of implanted patients achieved at least 50% pain relief.
    53% needed no analgesics post-SCS.
    40% returned to work.
    70% were satisfied with SCS.
    
    Taylor RS, Van Buyten JP, Buchser E. Spinal cord stimulation for chronic back and leg pain and failed back surgery syndrome: A systematic review and analysis of prognostic factors.Spine.2005;30:152-60.
  
  
  • Cost-effectiveness
    SCS pays for itself within 2.1 years with patients who have clinically effective SCS.
    Bell GK, Kidd D, North RB. Cost effectiveness analysis of spinal cord stimulation in treatment of failed back surgery syndrome. J Pain Symptom Manage. 1997;13:286-295. Cited by: Stojanovic MP, Abdi S. Spinal Cord Stimulation. Pain Physician. 2002;5(2):156-166.
  
  
  • Another study by Kumar determined the average cumulative cost for SCS therapy for 5 years was $29,123 per patient, less than the per-patient cost of $38,029 for conventional pain therapy.
    Kumar K, Malik S, Demeria D. Treatment of chronic pain with spinal cord stimulation versus alternative therapies: cost-effectiveness analysis. Neurosurgery 2002;51:106-116.
  
  
  • A cost-benefit analysis by Mekhail et al. in the Clinical Journal of Pain revealed that the cost savings associated with SCS was $30,221 per patient per year.
    Mekhail NA, Aeschbach A, Stanton-Hicks M. Cost benefit analysis of neurostimulation for chronic pain. Clin J Pain. 2004;20:462-468.
  
  
• 7. There are neuromodulation specialists in your area. There are approximately 600 members of NANS located across the United States. Membership includes physicians of different backgrounds, all of whom specialize in pain, spasticity and movement disorders. A member in your local area can be found by visitinghttp://www.neuromodulation.org/


• 8. Neuromodulation procedures are covered by most medical insurance and Medicare programs. As with all medical procedures, the patient must check with their insurance plan to receive proper approvals.


• 9. Patient care is of the utmost importance to neuromodulation specialists. Members of NANS are concerned first and foremost with the care given to their patients and the impact the neuromodulation program has on their patients’ lives.


• 10. Neuromodulation is NOT SCIENCE FICTION. New scientific advances and expanding clinical indications will continue to fuel the growth of this dynamic field in the coming decade but the results it can bring to pain sufferers is real today.
  
  About the North American Neuromodulation Society (NANS): The North American Neuromodulation Society (NANS) is dedicated to being the premier organization representing neuromodulation. NANS promotes multidisciplinary collaboration among clinicians, scientists, engineers, and others to advance neuromodulation through education, research, innovation and advocacy. Through these efforts NANS seeks to promote and advance the highest quality patient care. http://www.neuromodulation.org/

ELECTRICAL STIMULATION THERAPIES
Brain and Spinal Cord Therapies
There are two types of pain. Neuropathic pain is described as burning, or shooting shock like pain. This type of pain tends to be resistant to treatment with pain medications such as opiods. This type of pain can result from nerve damage or abnormal nerve conduction which can be seen after surgery. Nocioceptive pain is a dull, throbbing pain which is more amendable to treatment with pain medications. It results from irritated nerves by your skin or organs. This is seen commonly in cancer, or after a fracture. Many therapies target the brain and spinal cord, the root of the nervous system, to deliver relief to patients. Brain and spinal cord neuromodulation therapies that are currently in use as well as in development today, include the following:

• Spinal Cord Stimulation - Spinal cord stimulation is the most common form of neurostimulation and administers low voltage stimulation to the spinal cord or a targeted nerve to hinder or block the transmission of pain. The system is implanted in a space surrounding the spinal cord, called the epidural space where it stimulates pain- inhibiting nerve fibers which can mask the sensation of pain with a tingling sensation. The lead is attached to a power source which can be implanted in different locations such as the abdomen or buttocks. You will also have a hand held remote control so that you can turn the device on and off as you wish and make adjustments to the stimulation.
  
  Spinal cord stimulation may be a treatment option for the management of chronic pain, most specifically neuropathic pain, but also ischaemic pain and visceral pain. It is a reversible therapy which can be tested before permanent implantation. This type of pain can result from nerve damage or abnormal nerve conduction such as pain exhibited with failed back syndrome, post surgical pain, multiple back operations, and various other conditions which can be evaluated by the treating physician.
  
  The goal of neurostimulation is to reduce pain, rather than to eliminate pain. It has been shown to have a 50% improvement in pain relief, reduce the use of more medications, and also allow the pursuit of a more active lifestyle which may have been hindered by the pain.
  
  
• Deep Brain Stimulation (DBS) - A small device, similar to a pacemaker, is surgically implanted to deliver electrical stimulation to targeted areas of the brain. This procedure is used to treat a variety of disabling neurological symptoms, including pain, tremors and movement disorders that can be associated with Parkinson disease, as well as pain, depression, tourettes syndrome, stroke recovery, hypertension, addiction disorders and epilepsy. DBS can also be applied to treatment for severe intractable depression and obsessive-compulsive disorder.
  
  
• Cortical Stimulation - Viewed as a potential alternative to Deep Brain Stimulation, cortical stimulation is being used to treat pain, and is under investigation to treat stroke, movement disorders and depression. The pace of activities and promising clinical results bode well for the future of this therapy.
  
  
• Cerebral Cortex Stimulation (Motor Cortex Stimulation) - Stimulation of the cerebral cortex has been shown to relieve neuropathic pain. The cerebral cortex is the area of the brain responsible for many complex functions such as memory, language and consciousness. Motor cortex stimulation stimulates the part of the brain that controls movement and is used to treat drug-resistant neuralgia pain such as pain after a stroke.
  
  
• Sacral Nerve Stimulation (also known as Urologic Nerve Stimulation) - A small electrode tip is placed near the sacral nervethe nerve that controls voiding function in the lower spine. An implanted device stimulates the nerve to act as a sort of pacemaker for the bladder, improving urinary function and reducing or eliminating pain.

Peripheral Nerve Stimulation
Similar to the way that spinal cord stimulation and deep brain stimulation work on the spine and brain, peripheral nerve stimulation involves the implantation of a device along the peripheral nerves—limbs, for instance—to further target the delivery of electrical impulses. There are currently two types of peripheral nerve stimulation therapies in use today.

• Occipital Nerve Stimulation Stimulation - A subcutaneous electrode is placed at the back of the skull stimulating the occipital nerves to relieve pain, migraines, cluster headaches and hemicrania (a type of headache).
  
  
• Pudendal Nerve Stimulation - Pudendal nerve stimulation is an alternative method to sacral nerve stimulation to treat incontinence. Stimulating the pudendal nerve, which controls the pelvic floor muscle, can improve the function of the bladder and pelvic floor muscle groups. It can also be used as a treatment for urogenic, iliac crest and abdominal pain.

Cranial Nerve Stimulation
There are 12 pairs of cranial nerves controlling a host of motor and sensory functions. The following two therapeutic applications for cranial nerve stimulation include the following.

• Vagus/Vagal Nerve Stimulation - The vagus nerve is one of a dozen pairs of cranial nerves controlling motor and sensory functions of the viscera. Electrical stimulation of this nerve has been found to affect the connections within the brain that are prone to seizure activity, and has also shown a positive effect on mood in patients who have tried antidepressant medications without symptom relief.
  
  
• Trigeminal Nerve Stimulation - One of 12 pairs of cranial nerves, stimulation of the trigeminal nerve has been shown to reduce seizure activity in epilepsy.

Functional Electrical Stimulation
Using implanted devices to generate electrical impulses to activate nerves and restore function in patients with paralysis from spinal cord injuries, stroke, head injury or other neurological disorders. These devices can also restore neural activity in cases of sensory damage, including cochlear implants for deafness and retinal stimulation for blindness caused by macular degeneration or retinitis pigmentosa. Some examples of these therapies include:

• Retinal Stimulation - Devices are being developed to restore vision to patients blinded by retinitis pigmentosa or macular degeneration. These devices mount tiny cameras or receivers on a pair of glasses and process the images into electrical signals that are transmitted to electrode arrays implanted within the retina. The signals travel to the brain through the optic nerve, enabling the patient to see patterns of light and darkness. With practice, these individuals can interpret these patterns into useful images that help them to navigate and identify their surroundings.
  
  
• Cochlear Implants - A cochlear implant is a small electronic device that is implanted in the skull to restore hearing in a deaf individual by bypassing damaged portions of the ear and going directly to the auditory nerve. The device has a series of parts: an external microphone; a speech processor, which arranges the sounds that the microphone has picked up; a transmitter and receiver, which receive signals from the speech processor and convert them into electrical impulses; and an electrode array, which collects the impulses from the stimulator and transmits them to various locations along the auditory nerve. While it does not restore normal hearing, it provides a representation of sounds that enables the deaf person to hold conversations and function more normally. According to the Food and Drug Administration, more than 100,000 people worldwide have received cochlear implants.
  
  
• Diaphragm (Phrenic) Pacing - The market for implanted diaphragm stimulation systems is experiencing steady developments, both in clinical and financial terms. Phrenic pacing provides ventilatory support for patients with chronic respiratory insufficiency whose diaphragm, lungs, and phrenic nerves have residual function. Typically, these patients have high spinal cord injuries, a paralyzed diaphragm, central sleep apnea or other central neurological disorders.

PHARMACOLOGICAL THERAPIES
Pharmacological therapies work by surgically implanting pumps that deliver pain medication directly to the target site, enabling lower dosages and mitigating the side effects that certain pain medications can cause. Some examples of pharmacological therapies include:

• Intrathecal/Intraspinal Drug Delivery - Pain medication is administered directly to the area around the spinal cord via a surgically placed pump and catheter. By directing medication directly to the site of pain, less medication is necessary, and with fewer side effects than are seen with orally administered drugs that require metabolization. New agents such as ziconotide have profound analgesic effects with fewer side effects, it can only be given by intrathecal drug delivery.
  
  
• Intraventricular Drug Deivery - Intracisternal drug delivery is the delivery within the cerebrospinal fluid of the cistern (C1-2 vertebra) and intracranial ventricles of analgesic agents. As with intrathecal delivery, by directing medication directly to the site of pain, less medication is necessary, and with fewer side effects -- than are seen with orally administered drugs that require metabolization.This delivery system requires an implanted intracisternal or intraventricular catheter connected either to an implanted programmable or non-programmable pump or to an external pump.Intracisternal delivery and intraventricular delivery of analgesic agents are usually used for patients with head and neck pain, as in pain from tumors of the face and neck.