Dr. Joel R. Saper and Michigan Head•Pain & Neurological Institute (MHNI) are conducting a research study evaluating an investigational device for the treatment of chronic cluster headaches. Detailed information regarding the study can be found below.
If you are interested in participating, please call (734) 677-6000, option 4 to speak with a research nurse (available between the hours of 8 a.m. and 5 p.m., Monday through Friday) or complete a study application form
Chronic Cluster Headache Study Details
It is estimated that the number of people in the U.S. who suffer from cluster headache is similar to the number who suffer from Parkinson's disease or multiple sclerosis.
Living with cluster headache can be very difficult. The repeated cluster attacks leave many sufferers unable to fully participate in daily activities. If you are like many cluster headache sufferers, you have probably tried many approaches to relieve your pain, and may be using medications regularly to manage the attacks.
If you suffer from chronic cluster headache and have found preventive and/or acute cluster headache treatments to be inadequate for you, you may be a candidate for the Pathway CH-2 chronic cluster headache study. The study is evaluating the ATITM Neurostimulation System, an investigational device designed to provide targeted cluster headache relief.
Cluster headache is a very disabling condition. Sufferers can have cluster attacks many times per day, each lasting 15 minutes to 3 hours. Cluster headache is often called 'suicide headache'. The pain caused by cluster attacks is one of the most severe pains known to humans.
Living with cluster headache can be very difficult. When an attack occurs, the intense stabbing pain around one eye, usually accompanied by droopy eyelids with tearing and nasal congestion or runny nose, often results in patients becoming withdrawn and isolating themselves. These repeated attacks leave many sufferers unable to fully participate in life, work, or the activities they enjoy with family and friends.
Since many cluster headache sufferers have gone for years without an accurate diagnosis or adequate treatment, it is important to be seen by a headache specialist.
Pathway CH-2 Cluster Headache Study
Headache treatment centers throughout the U.S. are participating in the Pathway CH-2 cluster headache clinical study. The study is for individuals who suffer from chronic cluster headache. The study is evaluating the ATI Neurostimulation System, an investigational device designed to provide targeted cluster headache relief.
Participants in the Pathway CH-2 cluster headache study will be treated for chronic cluster headache with the ATI Neurostimulation System. If you qualify and choose to participate, you will be treated by a team of headache specialists.
The ATI Neurostimulation System
What is SPG Stimulation Therapy?
The SPG (sphenopalatine ganglion) is a nerve bundle located behind your nose that is known to play a major role in severe headache. SPG stimulation therapy is designed to allow you to provide direct, local stimulation to the SPG and to interrupt nerve signals that cause cluster attack pain.
What is the ATI Neurostimulation System?
The ATI Neurostimulation System is an investigational device for the treatment of cluster headache, developed by Autonomic Technologies, Inc. The ATI system provides SPG stimulation therapy, which is designed to provide relief from the pain of cluster attacks.
The ATI Neurostimulator, smaller than an almond, stimulates the SPG nerve bundle. A doctor inserts the neurostimulator by a minimally invasive oral procedure, through a small incision in your gum, leaving no visible scars. It is placed on the side of your face affected by cluster headaches. After the device is inserted, it is left in place.
To activate your neurostimulator, you hold the ATI Remote Controller on your cheek. This allows you to control when you receive SPG stimulation therapy.
Do You Qualify?
If you have been diagnosed with chronic cluster headache and have found preventive and/or acute cluster headache treatments to be inadequate for you, you may be a candidate for the Pathway CH-2 chronic cluster headache study.
To participate in the study you must:
- Be at least 22 years old
- Have been diagnosed with chronic cluster headache according to the 2013 ICHO criteria
- Suffer from at least 4 cluster attacks per week on the side where you typically feel the attacks
- Have judged, with your doctor, that previously or currently used medication treatment for your cluster headache are inadequate for you
- Be able to distinguish cluster attacks from other headaches such as migraine or tension-type headaches
If you qualify and choose to participate in the study, during the first several months you will need to agree not to participate in certain other therapies. Your doctor can tell you more about this. During these first several months you will also need to maintain you current preventive headache medication and agree not to use any acute medications for attacks that you are able to treat with SPG stimulation therapy. To participate in the study, you will have to complete numerous follow-up visits in-person at the headache treatment center where you enroll into the study. Participation in the study is at no cost to you which includes the neurostimulation system and any examinations or visits required for the study.
CAUTION: The ATI Neurostimulation System is an investigational device and is limited by United States law to investigational use.