1. ATI NEUROSTIMULATOR SYSTEM for cluster headaches
Autonomic Technologies Inc.

2. 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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3. Cluster Headaches- overview
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4. Cluster Headaches- pathophysiology
Trigeminal Nerve Pathway
Sphenopalatine Ganglion
Autonomic Technologies Inc.

5. 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
*Maxillary Branch
Ophthalmic Branch
Mandibular Branch
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6. 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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7. Cluster Headache- pathophysiology
SPHENOPALATINE GANGLION (SPG)
Large, extra-cranial parasympathetic ganglion
Located deep in the face, behind the nose (on each side)
Autonomic Technologies Inc.

8. 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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9. 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
Autonomic Technologies Inc.

10. ATI NEUROSTIMULATOR SYSTEM
Autonomic Technologies Inc.

11. 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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12. ATI NEUROSTIMULATOR SYSTEM
Autonomic Technologies Inc.

13. 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
Autonomic Technologies Inc.

14. Patient Control of Neurostimulator
Patients control their own neurostimulator as needed
Use a remote control device
Autonomic Technologies Inc.

15. 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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16. 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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17. 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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18. 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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19. 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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20. Why Use this Device?
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21. Current Availability Currently available in Germany and Denmark only
Prescription Required
Cost?
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22. 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
Autonomic Technologies Inc.

23. 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
Autonomic Technologies Inc.