Transcript ATI NEUROSTIMULATOR SYSTEM for cluster headaches

ATI NEUROSTIMULATOR SYSTEM
for cluster headaches
Autonomic Technologies Inc.
Cluster Headaches- overview
“Suicide” Headaches
• Painful and debilitating- interferes with normal daily functioning
• Symptoms: excruciating pain typically located above one eye,
swelling, redness or tearing of the eye, drooping eyelid , facial
redness and sweating
• Cyclical pattern of attacks with or without remission
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Cluster Headaches- overview
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Cluster Headaches- pathophysiology
1. Trigeminal Nerve Pathway
2. Sphenopalatine Ganglion
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Cluster Headaches- pathophysiology
TRIGEMINAL NERVE PATHWAY
• Trigeminal Nerve- responsible for sensation of
the face (sensory fibers produce feelings of touch,
temperature and pain)
Three Branches
1. *Maxillary Branch
2. Ophthalmic Branch
3. Mandibular Branch
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Cluster Headaches- pathophysiology
TRIGEMINAL NERVE PATHWAY
• Responsible for
1. Autonomic (Involuntary) Symptoms: (eye drooping and
tearing, stuffed or running nose, swelling, sweating, ect)
2. Pain
- Neurotransmitters
- Vasodilators
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Cluster Headache- pathophysiology
SPHENOPALATINE GANGLION (SPG)
• Large, extra-cranial parasympathetic ganglion
• Located deep in the face, behind the nose (on each side)
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Cluster Headache- pathophysiology
SPHENOPALATINE GANGLION (SPG)
• The SPG mediates functioning of the trigeminal nerve fibers that
innervate the face
• Role in severe headache pain has been studied for over 100
years- many therapies target the SPG
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Treatment Options
•
Drugs
- Intranasal anesthetics (Lidocaine)
- Injectable medications (Sumatriptan)
Disadvantages: systemic side effects, dangerous for
patients with cardiovascular risk factors, patients can
become immune, don’t decrease attack frequency
• Inhaled Oxygen
Disadvantages: impractical and inconvenient, doesn’t
decrease attack frequency
• Deep Brain Stimulation
Disadvantages: surgical risk, internal bleeding, infection
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ATI NEUROSTIMULATOR SYSTEM
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Implanted Neurostimulator System
Contains a neurostimulator body, a lead and a fixation plate
• Neurostimulator Body
- Small size, 1.5 grams in weight and 5 mm in thickness
- Implanted in the gum above the second molar using oral surgery
- Programmed by a physician
- Rechargeable
• Lead
- Extends from the neurostimulator body to the SPG
- 6 electrodes stimulate the SPG nerve bundle (ganglion)
• Fixation Plate
- Anchored to the zygomatic process of the maxilla (cheekbone)
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ATI NEUROSTIMULATOR SYSTEM
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Implant Procedure
• Prior to the surgery, patient gets a CT scan
• Surgery done by oral surgeon under general anesthesia
(minimally invasive)
• Small incision made in the mouth in the upper gum
• Neurostimulator is implanted and incision is closed
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Patient Control of Neurostimulator
• Patients control their own neurostimulator as needed
• Use a remote control device
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How it works!
• High frequency stimulation (120 Hz) of the SPG
paralyzes maxillary nerve sensory fibers, thus
relieving sensation of pain in its peripheral
targets
• Possible Mechanisms
• 1. Acute relief- physiological block of parasympathetic efferents
to trigeminal nerve
• 2. Long term relief- depletion of stored NT in parasympathetic
efferents to trigeminal nerve
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Neurostimulator Device Benefits
• Acute Pain Relief
• Reduction in Cluster Attack Frequency
• *68% of patients experienced clinically significant improvements
in acute head disability, headache frequency, or both
• Quality of life improvements
•
75% of patients reported clinically significant improvements in
both their physical and mental quality of life
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Neurostimulator Device
Complications
Surgical Side Effects
- Swelling or discomfort in mouth and gums
- Pain in face, cheek, gum, mandible, nose or incision site
- Tooth pain or sensitivity
- Hematoma
- Seroma
- Infection (incision site infection)
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Neurostimulator Device
Complications
Neurostimulation Side Effects
- Sensory Disturbances (81% of patients)
- Mild paresis of muscles around naslabial fold
- Dry eye, tearing or tenderness in mouth
- Serious Adverse Events
Neurostimulator lead misplacement
Neurostimulator lead migration
Neurostimulator explantation
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Why Use this Device?
• Clinical Benefits
- Relieves cluster attack pain
- Reduces frequency of cluster attacks
- Improves quality of life
• Advantages over other options
- Practical and portable
- Unlimited use daily
- No systemic side effects
- Can be used by patients with cardiovascular symptoms or
vascular disease
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Why Use this Device?
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Current Availability
• Currently available in Germany and Denmark only
• Prescription Required
• Cost?
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Patient Protocols
Following Oral Surgery
• Hospital Stay: 1-2 days
• Avoid rapid bending, twisting or weight lifting for 6-8 weeks
• Avoid touching or putting pressure on the implant site
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Patient Protocols
Life with your ATI Neurostimulator
• Almost all normal activities can be resumed
• Can pass through metal detectors and full body X-ray machines
• Can get a full body MRI
• Use the device for as long as needed!
• Discuss cluster headache medication changes with your doctor
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