Behandling av hodepine med et nyutviklet kirurgisk instrument (MultiGuide) 03.05.2017 1
The InnoMet Team
Klinisk problemstilling Mann i slutten av 20-årene med klasehodepine Narkose eneste alternativ Lokalbedøvelse (nasalt) mot sphenopalatine ganglion (nerveknute) Bedring - kortvarig
Utfordring 1. Langvarig blokkering 2. Presisjon
Utfordring - Løsning 1. Langvarig blokkering Botulinumtoxin Primo 2013 2. Presisjon MultiGuide
Utfordring - Løsning 1. Langvarig blokkering Botulinumtoxin 2. Presisjon 2015 MultiGuide
Kort - MultiGuide Kan tilpasses forskjellige navigasjonssystemer Kliniske tester startet i oktober 2013: MultiGuide a safety study
https://www.youtube.com/watch?v=xkhzmrcl7ve
Sphenopalatine Ganglion
Uptodate.inc
Tidligere intervensjoner på sphenopalatine ganglion (SPG): - Kirurgisk destruksjon av sphenopalatine ganglion ( eks. radiofrequency) - Injeksjon av lokalanestetika (f. eks lidokain) Utfordring: Kompliserte prosedyrer eller kortvarig effekt
Author Year Headache Treatment N William 2015 Trigeminal neurophatic pain (TNP) Electric stimulation 7 Anesthesia dolorosa Persistent idiopathic facial pain (PIFP) Young 1995 Chronic facial pain Electric stimulation 23 Elahi 2015 Intractable facial pain Electric stimulation Case report Juto 2014 Acute migraine Kinetic Oscillation stimulation 36 Cady 2015 Chronic migraine Nasal bupivacaine 41 Schaffer 2015 Acute headache Nasal bupivacaine 93 Fang 2015 Episodic cluster Chronic cluster CT-guided radiofrequency 13 3
Pulsante stimulator system Autonomic Technologies Incorporated
Blocks signals in the SPG
Stimulation of the sphenopalatine ganglion (SPG) for cluster headache Treatment. Pathway CH-1: A randomized sham-controlled study. 32 patients included and 28 completed the study. Results: Pain relief in 67% on active stimulation and 7.4% on sham-stimulation Pain free in 34% on active stimulation and 1.5% on sham-stimulation
SphenoBlock vs. Pulsante stimulator SphenoBlock Pulsante stimulator Patients Migraine + cluster headache Chronic cluster headache Minimum cost of single treatment Approx. 350 Euros Approx. 30 000 Euros Cost of bilateral treatment Approx. 400 Euros Approx. 60 000 Euros Additional procedures Repeated injections every 3-12 months if effect 3% not able to insert stimulator. 21% re-operated (e.g. inappropriate placement, lead migration removal). Anaesthesia Local General Improvement in Quality of Life (HIT-6) 20,3% 10,3% Affects sensory fibers (side-effect) No Yes Operating room needed No Yes Type of treatment Prophylactic treatment Attack treatment Duration of procedure 30 minutes 80 minutes External device needed No Hand-held magnetic inductor Treatment related irreversible Adverse Events: 0 of 75 treatments 91 events per 99 treatments (84 events mild or moderate impact on daily activity. 7 events severe impact on daily activity).
Forskjellige indikasjoner
Tensjons-type hodepine Bilateral Trykkende Mild moderat Varer timer uker
Migrene Halvsidig (skifter side) Pulserende Moderat - kraftig Varer 4-72 timer Kvalme/Oppkast Lys/lyd sensitiv
Klasehodepine Ekstrem smerte Rundt/bak øyet Varer 15 180 minutter Inntil 8 anfall/ dag Autonome symptomer (tåreflod, rødt øye, hengende øyelokk) Uro
Persistent idiopathic facial pain (PIFP) persisterende smerte unilateral Daglige smerter >2 timer per dag i > 3 måneder lokalisert dypt i ansiktet/vanskelig lokaliserbar radierer utover trigeminus området eksklusjonsdiagnose
Pilot Studier -Klasehodepine - Migrene - Trigeminal nevralgi - Kronisk residiverende nesepollypose - Persisterende Idiopatiske ansiktssmerter (PIFP)
SphenoBlock Botulinum toxin type A block of the sphenopalatine ganglion Duration of effect on autonomous nervous system 3-9 (12) months
Main objective Investigate the safety Collect efficacy data
Method Intractable CH (n=10) Mean years since onset of cluster headache 15 years Number of preventive treatments failed 3,4 Pre-treatment preparation CT and MRI Treatment Transnasal approach (n=9), lateral approach (n=1) General anesthesia Follow-up 6 months
Figure 2. Number of attacks by intensity. Daniel Fossum Bratbak et al. Cephalalgia 2015;0333102415597891 Copyright by International Headache Society
Post-study data Cluster headache
Pilot study of sphenopalatine injection of onabotulinumtoxina for the treatment of intractable chronic migraine. Bratbak DF, Nordgård S, Stovner LJ Linde M, Aschehoug I, Folvik M & Tronvik E.
Method Intractable chronic migraine (n=10) Failing at least 3 migraine prophylactic drugs. Mean years since onset of migraine 29 years. Treatment Bilateral SphenoBlock Awake patient in outpatient office based setting Pre-treatment preparation CT and MRI of the paranasal sinuses Follow-up 3 months
Mean moderate/severe headache days per month Results main efficacy outcome Figure 1: Main efficacy measure. Mean moderate and severe headache days per month for baseline and after one single, bilateral onabotulinumtoxina treatment of the sphenopalatine ganglion, intention-to-treat analysis (n=10). 20 15 10 p=0.050 8 av 10 pasienter var respondere (>50% reduksjon vs baseline) 5 p=0.009 p=0.008 0 BL M1 M2 M3 BL: Baseline; M: Month (28 days). P-value for each month compared to baseline.
OtoBlock
MultiGuide clinical testing MultiGuide version 1 ended 80 patients included 75 SphenoBlock performed MultiGuide version 2 (class 3), started April 2016 400 patients will be included for 7 different procedures
SphenoBlock Studies - FUTURE Multinational, randomized, controlled trial on cluster headache, funded by national funds. Approx. 118 patients Lateral approach Aiming at inclusion of first patient autumn 2017? Botulinum toxin type A block of the sphenopalatine ganglion in patients with persistent idiopathic facial pain: a randomized, double-blind, placebo-controlled pilot study. Approx. 30 patients Lateral approach Aiming at inclusion of first patient winter/ 2017?
Nye bruksområder
Application areas MultiGuide Trigeminal neuralgia targeting trigeminal ganglion with glycerol (current pilot study) Intracranial tumors Trigeminal neuralgia targeting SPG with botulinum toxin (current pilot study ) Interventions on tumors and neural structures in the head and neck area Chronic sinusitis with nasal polyposis (current pilot study ) Atypical facial pain
Utprøvning av nye prosedyrer 1. Blokade av ganglion oticum 2. Behandling av trigeminusnevralgi ( sphenoblock + glycerol) 3. Behandling av kjeveleddsmerter (TMJ dysfunction) 4. Behandling av persisterende idiopatiske ansikts smerter (PIFP) 5. SphenoBlock ved kronisk bihulebetennelse med polypper 6. Behandling av abscesser og cyster i hode-hals området 7. Biopsi av tumores i hode/hals området
Den medisinske utstyrsprodusenten Karl Storz har et formelt samarbeid med InnoMet på forskning, utvikling og kommersialisering av MultiGuide. Legger grunnlaget for et langsiktig samarbeid med stor klinisk bredde.
MultiGuide MiniNAV
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