General remarks on Neurorejuvenation Spinal Cord Stimulation (SCS) Program Occipital Nerve Stimulation Gamma-knife for Trigeminal Neuralgia

Transcription

1 General remarks on Neurorejuvenation Spinal Cord Stimulation (SCS) Program Occipital Nerve Stimulation Gamma-knife for Trigeminal Neuralgia Deep brain Stimulation (DBS) Program

2 Neuromodulation is a field of science, medicine, and bioengineering that encompasses implantable and nonimplantable technologies, electrical and chemical, that improves life for humanity and is technology that impacts upon the neural interface INS Fastest growing medical field today worldwide, both in numbers of procedures performed and increase in indications for these procedures.

3 10 million in USA ready for neurorejuvenation 150,000 ready in WI

4

5 Concept of chronic disease management vs. cure Requires co-ordination of care, working together across many subspecialties (Neurosurgeon working with Pain Physicians) Successful Outcomes: Patient selection, trial, implant, programming, monitoring, learning to cope with new abilities Patients/families requiring care navigation throughout systems to optimize Outcomes/satisfaction

6 0 DEATH 3 CHRONIC NEUROPATHIC PAIN 4 CANCER 7 CARDIOVASCULAR DISEASE 10 (TIGER WOODS)

7 Patient Selection Criteria Moderate to severe symptoms Refractory to conservative management Positive response to trial screening Essentially Outpatient therapies Realistic patient goals Willingness to follow-up for programming

8

9 Prospective randomized trial (NEJM, 8/2000): assessed pain, global perceived effect, functional status, quality of life failed at least 6 months of treatments, psychologically cleared 36 patients: SCS + PT; 18 patients: PT alone 24 of 36 SCS trial patients passed Results at 6 months: *Pain score: 24 with implant (7.1 to 3.5) vs. PT alone: (6.7 to 6.9) GPE: implant (60% much improved) vs. PT alone (6% improved) QOL: implant significantly improved vs. PT alone Limb function: no significant difference (may break chain of pain)

10 Get a trial done within a year! (Kumar et al., 2006; 2013) Risk of failure increases by 5-10% for every year of delay! Return to work: 90% (3 months); 20% (6 mos); 2% (2 yr.)

11 Study: Patients: Results: Prospective, randomized comparison of Neurostim and re-operation (2005) 50 patients, all re-op candidates Results for the first 27 patients reaching the 6-month cross-over point show a statistically significant (P=0.018) advantage of Neurostim over re-operation. Results now over 3 years Source: North, Neurosurgery, 2005

12

13

14

15

16

17

18

19

20 An inter-disciplinary treatment which involves a neurosurgeon, radiation oncologist and radiation physicist, pain physician Concept of control of disease (with a delay) vs. immediate cure Non-invasive; out-patient, single-treatment Primary (meningioma, acoustic neuromas, Pituitary, gliomas) tumors and METS Trigeminal Neuralgia

21

22

23 Long-term Results of Initial and Repeat Treatment: 1 yr: 90-95% 2 yr: 85-90% 3 yr: 80-85% 4 yr: 70-80% 5 yr: 60-70%

24 DEEP BRAIN STIMULATION (DBS)

25 An FDA approved treatment for patients diagnosed with Parkinson s Disease, Essential Tremor and/or Dystonia Surgically implanted medical device, much like a pacemaker, that delivers electrical signals to very specific areas in the brain Proven to improve motor function in Parkinson s disease patients Tremor (uncontrolled shaking) Rigidity (stiffness) Bradykenesia (slow movement) Dyskinesia (caused by PD medications)

26 1987 First DBS implant (Europe); (my first in 1994) 1997 FDA approval for tremor; (my first paper) 2002 FDA approval for Parkinson s disease (PD) 2003 FDA grants Humanitarian Device Exemption for dystonia 2009 FDA grants Humanitarian Device Exemption for OCD

27 Put on localizing box with numbing medicine MRI or CT: tell us which ballpark Brain recordings: which seat in the ballpark

28

29 The second verification in targeting for symptom relief is Microelectrode recording (which seat in the ballpark). The patient must be alert during this part of the procedure to ensure proper placement of the DBS lead.

30 Inserted a week later as an outpatient under general (20 minutes) Typically placed below clavicle Connected to lead using extension Neurostimulators typically replaced every 3-5 years as needed. Patients also have the option of a rechargeable battery that lasts 9 years but requires recharging the device through the skin on a regular basis.

31 Over last 25 years: 100,000 DBS electrodes Worldwide (40,000 in USA; 1500/yr) Less than 10% penetrance Only about 30 of us with years of fellowship training doing more than about 50 implants/year accounting for most therapies in the country; another 100 or so trying to do a few per year after a weekend course.

32

33 We have now established one of 25 programs in country with our IRB approval

34 OCD Epilepsy (1-2 years) Depression 10:1 (2-3 years) Gait and Balance (PPN) Cluster Headaches (done in Europe) Alzheimer s Eating Disorders/Addiction (5-10 years)

35

36

37

38

39 What is best stimulation frequency/pattern No parasthesias?

40 Neurosurgeon on chronic pain management team to optimize patient care, satisfaction and outcomes. Collaborative/complementary relationship between neurosurgeon and pain physicians Spinal cord stimulation (paddle technologies), Occipital nerve stimulation, Gamma-knife Stereotactic Radiosurgery, Deep brain stimulation, Research/Education