Peripheral Neuromodulation for Headache and Craniofacial Pain by r5uhfBp

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									Neuromodulation for Headache
    and Craniofacial Pain

                Alon Y. Mogilner, M.D., Ph.D.
Chief, Section of Functional and Restorative Neurosurgery
                 Cushing Neuroscience Institutes
   Hofstra - North Shore – LIJ School of Medicine, Manhasset, NY
Disclosures
   Alon Y. Mogilner, M.D., Ph.D. receives honoraria
  and grant support from Medtronic, and grant
  support from St. Jude Medical
 Peripheral Neuromodulation for Headache and
  Craniofacial Pain is not FDA approved, and thus
  represents an off-label indication.
 Introduction
         Neurosurgical management of chronic headache and
          craniofacial pain syndromes has been an evolving
          concept over the past 50 years
         Early interest in neurostimulation, for these conditions,
          focused on deep brain targets
         Hosobuchi, Adams, and Rutkin, thalamic stimulation to
          treat facial anesthesia dolorosa, 19731
         Mazars and Pull, intermittent stimulation of nVPL to
          treat intractable headache, 19762


1.       Hosobuchi Y, Adams JE, Rutkin B. Chronic thalamic stimulation for the control of facial anesthesia
         dolorosa. Arch Neurol 1973;29(3):158-61.
2.       Mazars G, Pull H. Neurosurgical treatment of headaches. Minerva Med 1976; 67(31):2020-2.
Occipital Nerve Stimulation
 Goadsby (1997): Stimulation of greater occipital nerve
  (GON) in cats resulted in increased metabolic activity
  of the trigeminal nucleus caudalis and cervical dorsal
  horn3
 Weiner (1999): Peripheral neurostimulation for occipital
  neuralgia4
 Goadsby (2004): ONS for migraine headache5

    3. Goadsby PJ, Knight YE, Hoskin KL. Stimulation of the greater occipital nerve
    increases metabolic activity in the trigeminal nucleus caudalis and cervical dorsal horn
    of the cat. Pain 1997; 73(1):23-8.
    4. Weiner RL, Reed KL. Peripheral neurostimulation for control of intractable occipital
    neuralgia. Neuromodulation 1999; 2(3):217-21.
    5. Matharu MS, Bartsch T, Ward N, Frackowiak RSJ, Weiner RL, Goadsby PJ. Central
    neuromodulation in chronic migraine patients with suboccipital stimulators: A PET
    study. Brain 2004;127:220-30.
    Peripheral Stimulation: headache
    and facial pain

   Most Common technique:
    ◦ Occipital Nerve Stimulation
      Occipital stimulation
      “BOTH” stimulation
   Other techniques:
    ◦ Trigeminal branch stimulation
      Supraorbital
      Supratrochlear
      Auriculotemporal
Anatomy
   The occipital nerves are derived from C2
   The C2 ventral ramus merges with the cervical plexus
    and contributes to the lesser occipital nerve
   The sensory medial branch of the C2 dorsal ramus
    contributes to the greater occipital nerve
Mechanisms
 The mechanism of action of ONS has not been fully
  elucidated
 Afferents from pain-producing cranial structures (dura,
  blood vessels) likely source of primary headache
  syndromes
 Pain oftentimes is not constrained within trigeminal
  innervation territories
 There is frequently involvement of GON innervation
  territories
Mechanisms
   Role of Trigemino-Cervical Complex?
   Afferents from meninges terminate in caudal trigeminal
    nucleus, in medullary dorsal horn
   This nucleus extends down to C2
   Afferents from back of head travel along GON to C2
   Convergent Neurons
   Plasticity
   This model may not apply though
   Mechanism may actually be more similar to peripheral
    field stimulation (Pain Gate)
     Epidermis




        Dermis


Subcutaneous Tissue
                      Electrode
 Subcutaneous
       nerves
    Headache/Facial Pain

Headache                    Trigeminal neuralgia
 Tension headache           Trigeminal Neuropathic pain
 Migraine and equivalents     Postsurgical pain
Non-neurogenic pain           Postherpetic neuralgia
                              Anesthesia dolorosa
 Sinusitis
                            Central Post-Stroke pain
 TMJ pain
Cervicogenic headaches      Other cranial neuralgias
Occipital neuralgia
Cluster headache
    Headache/Facial Pain

Headache                    Trigeminal neuralgia
 Tension headache           Neuropathic pain
 Migraine and equivalents     Postsurgical pain
Non-neurogenic pain           Postherpetic neuralgia
                              Anesthesia dolorosa
 Sinusitis
                       Central post-stroke pain
 TMJ pain
Cervicogenic headaches Atypical facial pain
Occipital neuralgia
Cluster headache
Burchiel Classification of Facial
             Pain
•     Trigeminal neuralgia, type 1, (TN1): facial pain of
    spontaneous onset with greater than 50% limited to the duration
    of an episode of pain (temporary pain).
•     Trigeminal neuralgia, type 2, (TN2): facial pain of
    spontaneous onset with greater than 50% as a constant pain.
•     Trigeminal neuropathic pain, (TNP): facial pain resulting
    from unintentional injury to the trigeminal system from facial
    trauma, oral surgery, ear, nose and throat (ENT) surgery, root injury
    from posterior fossa or skull base surgery, stroke, etc.
•     Trigeminal deafferentation pain, (TDP): facial pain in a
    region of trigeminal numbness resulting from intentional injury to
    the trigeminal system from neurectomy, gangliolysis, rhizotomy,
    nucleotomy, tractotomy, or other denervating procedures.
•     Symptomatic trigeminal neuralgia, (STN): pain resulting
    from multiple sclerosis.
•     Postherpetic neuralgia, (PHN):pain resulting from trigeminal
    Herpes zoster outbreak. (SHINGLES).
•      Atypical facial pain, (AFP): is facial pain of unknown origin.
IHS ICHD-II Classification
Peripheral Stimulation: Procedure
   Percutaneous trial performed under local
    anesthesia
    ◦ ONS: Supine with head turned lateral position preferred
       prone position used in patients who could not be positioned supine/lateral
    ◦ Lateral or prone position
    ◦ Trial performed under local anesthesia with sedation (propofol,
      dexmetetomidine, versed)
    ◦ Intraoperative testing not always performed
    ◦ Leads placed horizontal approximately 1 cm above level of C1 arch
       May depend on previously placed hardware
         OC fusion hardware,
         VP shunt hardware
Procedure
                          ONS: technique




• Cranial and cervical hardware may alter patient positioning, electrode
  placement
Procedure: Percutaneous Trial
    Outpatient trial analogous to SCS trial (4-7
     days)
     ◦ Special considerations:
       Chronic migraine
         H/A wax and wane with menstrual cycle
       Cluster headache
         Delay in onset of efficacy
       Headache location:
         Frontal H/A with no radiation from occipital region
           Consider trigeminal branch leads
Procedure: Permanent Implant
    Patients usually return with trial leads in place
     ◦ Leads are removed after induction of general
       anesthesia
     ◦ New leads placed and anchored to retromastoid
       fascia
        Extensions rarely used
     ◦ Generator location:
        infraclavicular (most common)
        Flank/buttock
        abdomen
Procedure: Permanent Implant
              Complications
   Lead migration: most
    common ONS complication
   Surgical technique, anchoring
    technique not standardized
Complications: Wound Erosion
              Be proactive regarding
               potential wound erosions
              Hardware not optimized for
               peripheral applications
Complications: System Revision
Complications…
            Results: Literature
                 Survey




NANS 2009
      Neurostimulation for Migraine:
              Clinical Trials
   3 to date, Boston Scientific, Medtronic, St. Jude
   Most recent: St. Jude study
    ◦ Significant group differences for reduction in number of headache days,
      MIDAS, Zung PAD,VAS, quality of life and satisfaction at 12 weeks were
      observed (p< 0.05).
    ◦ In the Active and Control groups respectively, number of headache days
      (defined as a > 4 hours duration at moderate intensity) decreased by
      7.3 and 4.3, total MIDAS scores improved by 64.6 and 20.4, MIDAS
      headache days improved by 22.5 and 3.4, PAD scores improved by 13.3
      and 5.5, VAS scores decreased by 13.6 and 6.9, 37.1% and 17.3% of
      patients achieved a 30% reduction in VAS.
    ◦ In addition, 66.7% of patients in the Active group reported improved
      quality of life whereas only 17.2% of patients in the control group
      reported the same. For satisfaction, 51.4% of patients in the Active
      group reported being satisfied whereas only 19.2% in the Control group
      reported being satisfied.
    ◦ HOWEVER, primary endpoint (>50% pain reduction) not reached
 Peripheral Neuromodulation for
 Headache and Craniofacial Pain:
Indications, Outcomes, and Complications
           from a Single Center

Antonios Mammis, M.D.1,2, and Alon Y. Mogilner, M.D.1, Ph.D.
                 1Cushing Neuroscience Institutes
   Hofstra - North Shore – LIJ School of Medicine, Manhasset, NY
               2Department of Neurological Surgery

         UMDNJ – New Jersey Medical School, Newark, NJ
Objectives
 To review the indications and outcomes of peripheral
  neurostimulation for headache and craniofacial pain,
  from a single center experience
 To adopt a uniform classification scheme for headache
  and craniofacial pain, which is understood by the
  headache community, across multiple disciplines
 To review complications and promote strategies of
  complication avoidance
Methods
 Retrospective chart review from a single center
 2004-2011
 99 patients underwent peripheral neurostimulator trials
  for headache / craniofacial pain
 Retrospective classification of diagnoses according to
  the International Headache Society (IHS): ICHD – II
  classification scheme
 All procedures performed by AYM
 8 of the migraine patients were part of a multicenter
  randomized study (St. Jude Medical)
 Procedures performed included ONS and / or
  trigeminal branch stimulation
Demographics
   74 Females
   25 Males
   Mean Age: 43 (Range 11-68 yrs old)
Diagnoses: ICHD – II System
 Diagnosis                                                          Number of Patients

 7.7: Headache attributed to Chiari Malformation type I             28

 1.1 or 1.2: Migraine Headache with or without Aura                 24

 5.2.2: Chronic post-traumatic headache attributed to mild head     11
 injury


 13.8: Occipital Neuralgia                                          8


 5.7.2: Post-Craniotomy Headache                                    7


 3.1.2: Chronic Cluster Headache                                    5


 6.1.1: Headache attributed to ischemic stroke                      5


 13.7: Other terminal branch neuralgias                             5


 11.2.1: Cervicogenic Headache                                      4

 4.7: Hemicrania Continua                                           1


 7.4.4:Headache attributed to hypothalamic or pituitary hyper- or   1
 hyposecretion
Technique
 Trials performed under local anesthesia with
  intravenous sedation
 Bilateral Approach
 Intra-operative testing not performed, in most cases
 Surface anatomy and fluoroscopy for lead placement
 8 or 4 contact percutaneous leads
 Trial Period (4-7 days)
 Headache Diary: duration, frequency, and severity
  (Visual Analog Scale)
Technique
   Permanent implantation under general anesthesia
   Patient position depended on anatomy and planned
    location of pulse generator
   Bilateral lead placement, from a unilateral approach
   Radiographic confirmation of lead placement
   Pulse generator placed in subcutaneous pocket
Results
 79/99 (80%) patients reported significant improvement
  during trial
 Improvement was defined as 50% pain relief on VAS
 These patients proceeded to permanent implantation
Results
   56/79 (71%) Occipital Leads Only
Results
   12/79 (15%) Trigeminal Branch Only
             58 year old male s/p brainstem CVA with resultant
             left V1 and V3 distribution pain. Underwent trial and
             subsequent implant of left V1 (A) and V3 (B) region
             peripheral neurostimulators, with significant
             improvement in pain duration, frequency, and
             severity.
Results
   11/79 (14%) Both Occipital and Trigeminal
    Branch Leads



                            18 year old male with chronic cluster headache.
                            Intra-operative AP skull radiograph, demonstrating
                            supraorbital (A), infraorbital (B), and occipital (C)
                            neurostimulation leads. At 3 years follow-up, he
                            reported significant improvements in headache
                            duration, frequency, and severity.
Results
   Follow-up ranged from 1-65 months
   Mean follow up: 9 months
   At last follow-up, 65/79 (82%) patients, who underwent
    implantation, reported continued significant benefit from
    stimulator use.
Results: Analysis of Indications
Diagnosis                                   Number     Number of    Number of
                                            of         Successful   Permanent
                                            Patients   Trials       Systems still
                                                                    used at Last
                                                                    Follow-up
7.7: Headache attributed to Chiari          28         18           15
Malformation type I
1.1 or 1.2: Migraine Headache with or       24         21           19
without Aura
5.2.2: Chronic post-traumatic headache      11         10           8
attributed to mild head injury
13.8: Occipital Neuralgia                   8          7            7

5.7.2: Post-Craniotomy Headache             7          7            6

3.1.2: Chronic Cluster Headache             5          4            4

6.1.1: Headache attributed to ischemic      5          3            1
stroke
13.7: Other terminal branch neuralgias      5          4            1

11.2.1: Cervicogenic Headache               4          3            3

4.7: Hemicrania Continua                    1          1            1

7.4.4:Headache attributed to hypothalamic   1          1            0
or pituitary hyper- or hyposecretion
Complications
   Lead Migration necessitating Revision: 4/79 (5%)




    Migration of left occipital lead (*), in a   Left occipital lead replaced after
    patient with migraine headaches.             revision surgery.
Complications
 Wound erosion / infection, necessitating
  explantation: 3/79 (4%)
 Surgical site infection without wound erosion,
  necessitating explantation: 3/79 (4%)
 Of the 6 patients with infection, 3 were
  following initial implant and 3 followed revision
 Impending wound erosions were surgically
  revised, preemptively
Other Complications
   Revision surgery for other reasons:
    17/79 (22%)
   Superficial Placement / Cosmesis
   Distal to Proximal Revision
    Technique allowed for quick
    corrections of lead position,
    without exposing pulse generator
    site
Illustration demonstrating the distal to proximal
neurostimulator lead revision technique in a case
of a supraorbital stimulator. The original lead, in
situ (A). The temporal incision is opened and
the lead is pulled through (B). A curved spinal
needle is introduced through a forehead stab
incision to the temporal incision, in a plane
deeper than the original lead (C). The stimulator
lead is then introduced through the spinal needle
and tunneled deeper in a proximal to distal
fashion (D).                                          Mammis A, Mogilner AY. A technique of distal to proximal revision of
                                                      peripheral neurostimulator leads: technical note. Steretact Funct Neurosurg
                                                      2011;89(2):65-9.
Conclusions
 Peripheral neuromodulation is efficacious in a number
  of headache and craniofacial pain disorders
 Migraine Headache: most studied – CE approval
  obtained, FDA approval not as yet
 Other headaches (trigeminal autonomic cephalalgias)
  respond well to neurostimulation

								
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