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Backgrounder

Medtronic Media Contacts:
Rebecca Fancini, Public and Media Relations , +44 1923 212 213

NEUROMODULATION


What Is Neuromodulation?

  • Neuromodulation involves direct stimulation of the nervous system with electrical signals
  • It is used as a treatment for unmanageable chronic pain and/or movement disorders
  • There are a number of forms of neuromodulation:
    • Spinal Cord Stimulation (SCS): where the nervous tissues on a specific portion of the spinal cord are electrically stimulated to block pain signals to the brain
    • Peripheral Nerve Stimulation (PNS): where a specific nerve is targeted to relieve pain locally
    • Deep Brain Stimulation (DBS): is a highly targeted, mild electrical stimulation in the brain which influences movement control, specifically on either the subthalamic nucleus, the internal globus pallidus or the ventral intermediate nucleus of the thalamus

Which Patients Benefit From It?

  • Neuromodulation is indicated for patients with movement disorders and chronic pain that are not adequately controlled by drug therapy and who suffer from one of the following:1
  • Parkinson’s disease
  • Essential tremor
  • Primary dystonia
  • Chronic intractable pain of trunk and limbs including:
  • Chronic back and leg pain associated with Failed Back Surgery Syndrome (FBSS)
  • Complex Regional Pain Syndrome (CRPS)
  • Peripheral vascular disease (PVD)
  • Intractable angina pectoris (AP)
  • Before implantation of a system, neurosurgeons can perform a test to ensure that the patient’s symptoms respond adequately to Neuromodulation.  This prevents unnecessary costs, surgery and potential side-effects

How Does Neuromodulation Work?

  • Neuromodulation involves the surgical implantation of three components:
  • A lead – special insulated wires with an electrode at the tip that delivers mild electrical pulses to the affected area
  • Extension wires – connect the electrodes to the neurostimulator
  • A Neurostimulator – a small robust electronic device similar to a cardiac pacemaker.  The neurostimulator is implanted under the skin in the abdomen for SCS or in the upper chest for DBS.  Once programmed, the neurostimulator sends mild electrical pulses via insulated leads to targeted areas of the spinal cord, the nerves or brain to block the transmission of signals that either cause pain or movement disorders2,3
  • Implanting the neuromodulation system usually takes three to six hours for an experienced neurosurgeon

The Benefits Of Neuromodulation

  • Research conducted over the past two decades shows that neuromodulation is a safe, effective and durable treatment for chronic pain and movement disorders:
  • Over 60% of patients had a significant improvement in their pain and lifestyle following implantation of peripheral nerve stimulators4
  • In clinical trials, 59% of patients in with chronic pain reported good-to-excellent pain relief after an average follow-up of 5.5 years after SCS5
  • SCS has been shown to improve patients’ quality of life dramatically by improving sleep, eliminating the need for further surgery and by significantly reducing the need for strong pain killers 6,7,8,9,13
  • 61% of patients experienced an improvement in daily activities after SCS12
  • 31% of patients were able to return to work following SCS12
  • DBS patients have demonstrated long-term improvement of motor function in Parkinson’s disease, essential tremor and dystonia10,11,12
  • DBS provides dramatic quality of life improvement in Parkinson’s disease, essential tremor and dystonia14,15,16
  • Neuromodulation is reversible and adjustable – physicians can non-invasively manage the electrical parameters with a programmer to effectively control disease symptoms
  • Adverse events are usually reversible and transient and can often be resolved with adjustments of the stimulation parameter settings

References

1 Kemler MA, Barendse GA, Van Kleef et al.  Spinal cord stimulation in patients with chronic reflex sympathetic dystrophy.  N Engl J Med. 2000; 343 (9):618-624

2 Limousin P et al. Multicentre European study of thalamic stimulation in parkinsonian and essential tremor. Journal of Neurology, Neurosurgery and Psychiatry. 1999;66:289-296

3 Medtronic, Synergy Neuromodulation System 2005.

4 Mobbs RJ et al. Peripheral nerve stimulation for the treatment of chronic pain. Journal of clinical neuroscience. 2007; 14 (3): 216-221

5 Kumar K, Toth C, Nath RK et al.  Epidural spinal cord stimulation for treatment of chronic pain – some predictors of success.  A 15 year experience. Surgical Neurology. 1998;50:110-21

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

7 Barolat G, Oakley J, Law JD et al.  Epidural spinal cord stimulation for failed back surgery syndrome.  Neuromodulation. 2001; 4: 1

8 Kemler MA, Henrica CW et al. The effect of spinal cord stimulation in patients with chronic reflex sympathetic dystrophy: Two years’ follow-up of the randomised controlled trial. Annals of Neurology. 2004;55:13-18

9 Van Buyten JP, Van Zundert J, Vueghs P, Vanduffel L. Efficacy of spinal cord stimulation: 10 years of experience in a pain centre in Belgium.  European Journal of Pain. 2001;5:299-307

10 Krack P, Batir A, Blercome N et al, Five-Year Follow-up of Bilateral Stimulation of the Subthalamic Nucleus in Advanced Parkinson’s Disease, New England Medical Journal. 2003;349(13): 1925-1934

11 Sydow O, Thobois S, Alesch F, Speelman JD. Multicentre European study of thalamic stimulation in essential tremor: a six year follow-up. J Neurol Neurosurg Psychiatry. 2003; 74:1387-1391

12 Vidailhet M, Vercueil L, Houeto JL, Krystkowiak P, Lagrange C, Yelnik J et al. Bilateral, pallidal, deep-brain stimulation in primary generalised dystonia: a prospective 3 year follow-up study. Lancet Neurol. 2007; 6: 223-229


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