Autonomic Technologies, Inc. (ATI), the developer of the ATI Neurostimulation System designed for the treatment of severe headaches, today announced results of their clinical study in cluster headache, The robust, multi-centre, randomized, placebo-controlled clinical study is the largest study performed with a medical device for cluster headache.

The ATI Neurostimulation System includes a novel, miniaturized device that is implanted using oral surgery, leaving no externally visible scars. When the patient feels a cluster attack beginning, they hold a remote controller up to their cheek to begin the neurostimulation therapy.

The study showed that the ATI Neurostimulation System demonstrated clinical effectiveness in treating cluster headache, and provided significant improvement in patient quality of life and headache disability. The results were statistically significant:
• Pain relief at 15 minutes was achieved in 67.1% of treated attacks compared to 7.4% of sham treated attacks (p<0.0001)
• Pain freedom at 15 minutes was achieved in 34.1% of treated attacks compared to 1.5% of sham treated attacks (p<0.0001)
• The average number of cluster attacks per week was reduced by 31% (p=0.005), and 43% of patients experienced an average reduction of 88% in the number of attacks suffered
• 64% of patients experienced clinically significant improvement in headache disability (HIT-6)
• 75% of patients experienced clinically significant improvements in quality of life (SF-36v2 physical and/or mental component scores)
• Acute rescue medications were used in only 31.0% of treated attacks compared to 77.4% of sham treated attacks (p<0.0001), a reduction of 60%
• The ATI Neurostimulation System was well tolerated, and side effects were comparable to other similar surgical procedures and tended to be transient

Cluster headache is one of the most painful types of headache. Patients may experience multiple attacks daily or almost daily, associated with excruciating pain typically in the area of one eye. Each attack can last between 15 minutes and three hours.1 Often called 'suicide headaches' because of their severity, it is estimated that over 600,000 people across Europe suffer from cluster headaches.

"Cluster headaches cause so much disability that patients are often unable to function normally," said Prof. Dr. Jean Schoenen, Full Professor of Functional Neuroanatomy and coordinator of the Headache Research Unit at University of Liege in Liege, Belgium. "Current preventive treatments are often ineffective, and in many patients acute and preventive treatments may not be tolerated or are contraindicated. This new and innovative therapy offers a way for a significant number of patients to control the debilitating pain of cluster headache."

The ATI Neurostimulation System is a novel, rechargeable system, with an implantable neurostimulator that is smaller than an almond. Designed for the treatment of severe headache, the neurostimulator is activated using an external remote controller (similar in size to a smart phone), allowing patients to deliver as-needed stimulation to relieve the attack. After a headache is treated, the remote controller is simply moved away from the cheek, turning off stimulation therapy.

"The ATI Neurostimulation System is well tolerated and can be used as often as needed, without daily limitations or stimulation-induced side effects", said Prof. Dr. Rigmor Hoejland Jensen, Director of the Danish Headache Center at Glostrup Hospital in Denmark. "Based on the results of the study, this new treatment option offers a significant improvement in quality of life to the majority of patients."

The ATI Neurostimulation System works by stimulating the sphenopalatine ganglion (SPG), a nerve bundle deep in the face that for years has been shown to play an important role in cluster headache.

"For years clinicians have targeted the SPG to relieve severe headache, primarily by applying anesthetics and other agents to achieve a nerve block," said Prof. Dr. Arne May, Neuroscientist at the University Hospital Hamburg-Eppendorf and First Vice President of the German Migraine and Headache Society. "This study provides clear evidence that SPG stimulation is a feasible and effective therapy for the treatment of cluster headache."

"We are very pleased with the positive results of the clinical study," said Ben Pless, President and Chief Executive Officer of Autonomic Technologies. "We are delighted to start making the ATI Neurostimulation System available to cluster headache patients in Europe so that they may control their painful attacks."
The ATI Neurostimulation System is CE marked for the treatment of cluster headache. Initial centres in Germany and Denmark are now treating suitable cluster headache patients with the ATI Neurostimulation System. ATI plans to begin an investigational study of the device in the US in the near future. Patients who wish to explore this new therapy should ask their doctor for a referral to a headache specialist or neurologist who is qualified to evaluate, diagnose and properly manage cluster headache.


Doctors test device designed to 'turn off' cluster headaches
Published on August 19, 2014

For those suffering excruciating pain from cluster headaches, relief may soon be available from an investigational device being studied in a national multicenter clinical trial. Recently, doctors at The Ohio State University Wexner Medical Center performed the first surgery in the United States to insert a neurostimulator to provide relief from cluster headaches, which are more painful than migraines. "Cluster headache is one of the most severe and disabling chronic pain conditions known to humankind. That's why it's important to look at options to help these patients," said Dr. Ali Rezai, director of the Neuroscience program at Ohio State's Wexner Medical Center and one of the scientific developers of this technology.

During the outpatient surgery, sinus surgeon Dr. Bradley Otto and oral surgeon Dr. Peter Larsen inserted the device through a small incision in the patient's gum into the side of the face affected by cluster headaches. Autonomic Technologies Inc. developed the miniaturized, multi-channel peripheral nerve stimulator, which is smaller than an almond, to stimulate the sphenopalatine ganglion (SPG). The SPG is a nerve bundle located behind the nose and is known to play a major role in severe headaches.

"Through an incision about 2 centimeters long, we're able to place this device, then pass it around the back of the maxillary sinus, or the cheek sinus, into this area where this ganglion is situated," said Larsen, who is professor of oral and maxillofacial surgery in the College of Dentistry at Ohio State. "The device is very small, and the patient doesn't even sense that it's there."

When patients begin to feel a cluster headache starting, they hold the rechargeable handheld remote controller to their cheek to activate the stimulator to block the pain signals. The patient's physician can program the device to give the appropriate length and strength of stimulation.

"This nerve control center sits behind the cheek sinus and is involved in the transmission pathway of cluster headache," said Otto, who is director of rhinology in the Department of Otolaryngology at Ohio State. "And so by blocking or short-circuiting that involvement, we think it will help treat cluster headache. The beauty of the device is that there are no internal batteries or other structures that need to be routinely removed. So, once we make the incision in the mouth and we place this device back behind the cheek sinus, it can be left forever."

It's estimated that nearly 400,000 people in the United States suffer from cluster headache, which can happen many times each day, with each one lasting from 15 minutes to three hours. Cluster headache is often called "suicide headache" because the pain is so intense. Cluster headaches typically involve one side of the head, and are much more common in men. The headaches are so severe that they cause very disabling sharp and stabbing pain around and in the affected eye, along with pain in the nose, head and temple. Drooping eyelids, redness and tearing often accompany the eye pain, and there is no cure. "SPG interventions have been around for the past 100 years," said Rezai, including using anesthetics to block the SPG to surgical procedures to cut the SPG or chemically burning it. "The main advantage of neurostimulation is that it's reversible and adjustable, and you're just modulating and blocking the pain signals."

In all, up to 120 patients with cluster headaches will receive the experimental device as part of the multi-center clinical trial that will last several years.

Source:
The Ohio State University Wexner Medical Center

G'day trsixy, welcome, and I know you've asked this same question before.

I can't answer it myself, and we're usually much better at attending to new queries, but I just wanted to say hello and wish you well.

Hi and welcome Glendale

Sorry that the implant didn't help you at all.

Are you using an effective preventive and do you have abortives?

Working with a headache specialist?

Tell us more and we may be able to help.

I had this implanted back in 2015 and had it removed November of 2017. No help to me at all, if anything it caused more frustration then anything. I also have numbness in the roof of my mouth upper lip and nostril.