N e u r o m o d u l a t i o n : P a s t, P r e s e n t, F u t u r e Jean- P i e r r e V a n B u y t e n, M D, P h D

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2 N e u r o m o d u l a t i o n : P a s t, P r e s e n t, F u t u r e Jean- P i e r r e V a n B u y t e n, M D, P h D 2

3 disclosure Dr. J.P. Van Buyten is frequently participating as investigator in clinical trials initiated by companies actively involved in neuromodulation. Dr. J.P. Van Buyten served on Advisory Boards, and he has subsequently received consulting and speaking fees from different neuromodulation companies The authors declared no other conflicts of interest

4 PAST Neurostimulation PRESENT FUTURE 4

5 Origins of neurostimulation Scribonius: Therapeutic effects of electric shocks from Torpedo Fish used for gout in 15 ad 1 Demonstration that electrical shock causes muscle contraction as early as Melzak and Wall: Gate theory introduced in Gildenberg PL. History of Electrical Neuromodulation for Chronic Pain. Pain Medicine; 2006:7(S1):S7-S Melzak R, Wall PD. Pain mechanisms: a new theory. Science; 1965 Nov 19;150(3699):971-9.

6 5O Years of Painstim ( ) 6

7 FIRST Dorsal Column Stimulation March 24, year old man with severe diffuse pain Laminectomy, single 3x4 mm electrode sutured to dura Stimulation covered both incisional and original pain Intermittently experienced pain which could be controlled by variations of frequency Patient requested frequency be changed when he began to have discomfort Patient died of stroke from endocarditis few days later 1 Shealy CN, Mortimer JT, Reswick JB. Electrical inhibition of pain by stimulation of the dorsal columns: preliminary clinical report. Anesth Analg Jul-Aug;46(4):

8 Evolution in the technology RF fully implantable 8

9 To implantable neurostimulators Itrel (1984) Monopolar Mode, Quad Lead, Magnetic Mode Itrel 2 (1988) Patient Programmer Itrel 3 (1994) Intraoperative Test Synergy (1998) Dual Channel Itrel 4 (2012) New Programmer, 1.5 MRI Conditional for Head/Neck 9

10 RF fully implantable contacts Non rechargeable batteries NEUROSTIMULATION TONIC BURST HIGH FREQUENCY HIGH DENSITY...????? MRI compatibility Other Targets DRG, PNS

11 PAST Neurostimulation PRESENT FUTURE 11

12 New Waveforms PRESENT NEW TARGETS 12

13 BURST HIGH FREQUENCY HF10 NEW WAVEFORMS HIGH DENSITY 13

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15 Burst stimulation may exert its main effect through an ability to modulate both lateral & medial pathways Pain stimuli are likely processed in parallel by two pathways: Lateral discriminatory pathway helps identify the location, type and intensity of pain Medial affective/attentional pathway helps drive attention & salience to the pain 1. De Ridder D, et al. World Neurosurgery Lopez-Garcia JA, and AE King. Eur J Neuroscience Larry R. Squire, Darwin Berg, Floyd E. Bloom, Sascha du Lac, Anirvan Ghosh, Nicolas C. Spitzer. Fundamental Neuroscience. 3rd Edition, Chapter 25: Somatosensory System, Academic Press (Elsevier), p. 599,

16 VAS Pain De Ridder D et al. Neurosurgery preoperative tonic burst axial limb left limb right 16

17 McGill BurstDR sensory affective preoperative tonic burst 17

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19 HF10 TM Therapy Hypothetical MoA: 10kHz-Frequency Desynchronization Low Frequency: All neurons follow in lock-step with stimulus Non-varying 10kHz Frequency: Each neuron fires at its own rate, pattern Average rate for each neuron different from neighboring neurons Low f Stimulus 10 khz desynchronization may drive neurons fast, each at more own natural rate and pattern High f Stimulus Adapted from Rubinstein et al Courtesy of Kerry Bradley

20 Back Pain (VAS score) Back Pain Relief (change in VAS score) SENZA-RCT: Superior Back Pain Relief with HF10 Therapy At 12 months, mean back pain VAS decreased 66% with HF10 therapy compared to a decrease of 45% for traditional SCS therapy Test (HF10 therapy) Control (Traditional SCS) Assessment (months) 100% 80% 60% 40% 20% 0% Assessment (months) 66.4% 44.7% Superiority p-value <0.001 Analysis of permanent implant population 20

21 Back Pain VAS (cm) Back Pain Relief HF10 Therapy: SENZA-RCT At 18 months, mean back pain VAS decreased 65% with H therapy compared to a decrease of 43% for traditional SCS therapy 10 Test (HF10) therapy) Control (Traditional) SCS) 100% % 80% 70% 64.9 % % 50% 40% 30% 42.5 % 2 20% 1 10% Assessment (month) 0% Assessment (month) Analysis of permanent implant population (P<0.001) 21

22 Dorsal Root Ganglion PERIPHERAL NERVES NEW TARGETS MEDIAL BRANCH Trigeminocervical complex 22

23 FUTURE OF NEUROMODULATION CURRENT INDICATIONS FBSS FNSS FBSS 23

24 FBSS BSCI MDTR ABBOTT NEVRO? 24

25 NEW INDICATIONS headache PDPN Facial pain Ppostop neuropathic pain 25

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27 Lowering of firing thresholds Spontaneous AP generation by cells in DRG Chronic Neuropathi c Pain Spontaneous, repetitive AP propagation in absence of Reduced Ca conductance noxious stimuli Na channel mutations Source: Deer, et al, Neurology Reviews, 2012 Reduced AP thresholds T Junction decrease of excitability of the cell mambrane Modulation of the filter process at the T- Junction influencing the propagation of AP to the spinal cord and further to the CNS Sources: Rush et al., PNAS, 103: , Lirk et al., Anesth Analg, 107: ,

28 The Dorsal Root Ganglion Gatekeeper Railway marshalling station Highway intersection These terms indicate the key roll in relaying sensory information to the central nervous system 28

29 The Somatotopic Arrangement of the DRG Cell bodies are also somatotopically arranged and organized. Sciatic nerve neurons distributed medially and ventrally and the femoral nerve neurons dorsally and rostrally Blue = Sciatic Nerve Red = Femoral Nerve Apuigdellivol-Sanchez, Molander, et al, 1998, Neurosci Lett, Sciatic and femoral nerve sensory neurons occupy different regions of the L4 dorsal root ganglion in the adult rat. Jul 31;251(3):

30 Stimulating the DRG 30

31 Implant technique 31

32 Eelectrode on L2 32

33 Treatment possibilities with DRG Stimulation Post-Surgical Neuropathies Post Mastectomy Post Thoracotomy Peripheral Neuropathy FBSS CRPS of the Hand Neuropathic Groin Pain CRPS of the Knee Post-Amputation Pain Diabetic Neuropathy CRPS of the Foot 33

34 Pain Practice. 2015; 15 (3):

35 CRPS of the foot Left foot pre-stimulation Sympathetic chain DRG Left foot after 4-weeks of DRG stimulation 35

36 PAST Neurostimulation PRESENT FUTURE 36

37 NEW INDICATIONS 37

38 DRG stimulation Direct stimulation Gasserian Ganglion Pterygopalatine Ganglion 38

39 Trigemino-cervical complex Indirect stimulation Medial Branch 39

40 Facial Pain Chronic Non specifique Back pain Cluster Headache What can we treat by stimulating directly or indirectly the ganglia Neuropathic pain Arm, Leg, Foot Hand, Back Post-OP pijn Headache Migraine. Other headache disorders 40

41 Stimulation of the Gasserian Ganglion 41

42 Gasserian Ganglion Stimulation for Trigeminal Neuropathy Dental surgery Maxilo-facial/plastic surgery Trauma fracture Treatment of trigeminal Neuralgia ( RF, GK, glycerol... Postherpetic neuralgia 42

43 Tripolaire elektrode Tripolaire elektrode 43

44 J. Neurosurg review. 2011; 1 (S1): Neuromodulation. 2009; 12 (3) J. Cranio-Maxillo-Facial Surgery. 2017; 45 (1) :

45 Trigemino-cervical complex Indirect stimulation Medial Branch 45

46 Trigemino-cervical complex (TCC) 46

47 TCC as a target for stimulation By stimulating the field around the MON we can treat many headache disorders. Unfortunately in the literature it was born as ONS( Occipital Nerve Stimulation), in fact it is ONF(ield)S. 47

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49 Results ICHD-II 13.12* Number of Patients % Pain Relief At Long Time FU Medication Overuse % Medication Overuse % 49

50 Results (2) ICHD-II 1.1, 8.2 * Number of Patients % of pain relief At long time FU Medication overuse+ Medication overuse % 3 78% * Migraine without aura 50

51 Medial branch stimulation Dorsal ganglion Posterior Ramus Medial Branch 51

52 Multifidus muscle Axial load bearing, endurance muscle Multifidus 52

53 Chronic Non Specifique Low Back Pain Muscle Atrophy 53

54 Breaking the Vicious Cycle of Chronic LBP INITIAL INJURY JOINT PAIN DISRUPT NEURAL CONTROL SPINAL INSTABILITY MUSCLE ATROPHY RESTORING MUSCLE NEUROMUSCULAR REACTIVATION 54

55 Implant technique 55

56 Localisation of the electrodes Intervertebraal formanen met DRG Intervertebraal foramen met DRG 56

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58 Results Resultaten: 26 patiënten 58

59 Dorsal ganglia Direct stimulation Gasserian ganglion Pterygopalatine ganglion 59

60 Final 3D Placement Source: Autonomic Technologies 60

61 Future: hybrid stimulation 61

62 Conclusion The future of Neuromodulation New waveforms New targets FBSS is only one of the multople indications Need for technical and technological evolution Use of EM neuronavigation guidance Development of specifique needles, leads, devices Explore more new waveforms waveforms EDUCATION!!!!!!!! Difficult techniques, learning curves 62

63 Try interventions before medication 63

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65 THANKS!!!!! 65

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