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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 Autonomic Technologies Inc. Cluster Headaches- overview Autonomic Technologies Inc. Cluster Headaches- pathophysiology 1. Trigeminal Nerve Pathway 2. Sphenopalatine Ganglion Autonomic Technologies Inc. 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 Autonomic Technologies Inc. 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 Autonomic Technologies Inc. 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. 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 Autonomic Technologies Inc. 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. ATI NEUROSTIMULATOR SYSTEM Autonomic Technologies Inc. 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) Autonomic Technologies Inc. ATI NEUROSTIMULATOR SYSTEM Autonomic Technologies Inc. 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. Patient Control of Neurostimulator • Patients control their own neurostimulator as needed • Use a remote control device Autonomic Technologies Inc. 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 Autonomic Technologies Inc. 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 Autonomic Technologies Inc. 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) Autonomic Technologies Inc. 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 Autonomic Technologies Inc. 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 Autonomic Technologies Inc. Why Use this Device? Autonomic Technologies Inc. Current Availability • Currently available in Germany and Denmark only • Prescription Required • Cost? Autonomic Technologies Inc. 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. 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.