Neurostimulation System Highly Effective in Cluster Headache

A new device that is based on stimulation of the sphenopalatine ganglion (SPG) helps reduce the frequency of cluster headache attacks.

The ATI Neurostimulation System is a novel, rechargeable system, with an implantable miniaturized neurostimulator (smaller than an almond) that is placed via the mouth, leaving no externally visible scars. Designed for the treatment of severe headache, the neurostimulator is activated using an external remote controller that is held up to the cheek, allowing the patient to deliver as-needed stimulation to relieve the attack. After a headache is treated, the remote controller is simply moved away, turning off the stimulation therapy. The ATI Neurostimulation System is a product of Autonomic Technologies (ATI; Redwood City, CA, USA), and has received the European Community (CE) marking of approval.


In a placebo-controlled clinical study, the ATI Neurostimulation System demonstrated effectiveness in treating cluster headache, and provided significant improvement in patient quality of life and headache disability. Pain relief at 15 minutes was achieved in 67.1% of treated attacks, compared to 7.4% of sham treated attacks. Pain freedom at 15 minutes was achieved in 34.1% of treated attacks, compared to 1.5% of sham treated attacks. The average number of cluster attacks per week was reduced by 31%, and 43% of patients experienced an average reduction of 88% in the number of attacks suffered. The study results were published early online on February 6, 2013, in Cephalalgia.

“Cluster headaches cause so much disability that patients are often unable to function normally,” said lead author Prof. Jean Schoenen, MD, PhD, coordinator of the headache research unit at the University of 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.”

Cluster headache is a highly disabling chronic neurological condition characterized by intense stabbing pain in the area of one eye, often accompanied by swelling, tears, and nasal congestion. Patients suffering from cluster headache may experience multiple attacks daily or almost daily, with each attack lasting between 15 minutes and three hours. Often called “suicide headaches” because of their severity, it is estimated that over 600,000 people across Europe alone suffer from cluster headaches.

Related Links:
Autonomic Technologies
University of Liege