Those of you suffering with cluster headaches (CH) know that there are few satisfactory treatments. Currently, the mainstay of cluster headache treatment consists of inhaled oxygen and parenteral triptans, but the ATI Pulsante SPG Microstimulator may change that.
Neurostimulation for CH?
Autonomic Technologies, Inc. (ATI) has developed the Pulsante™ SPG Microstimulator System to provide on-demand SPG stimulation therapy with the intention to relieve the acute debilitating pain of cluster headache. The Pulsante System is a minimally-invasive, rechargeable, multi-channel, peripheral nerve stimulation system. The System includes:
The Insert: A microstimulator (smaller than an almond) with an integral lead designed to fit ranging facial anatomy. The insert has CE-marked MR Conditional labeling for whole-body MRI.
The Remote Controller: A hand-held device with simple therapy controls that provides on-demand patient-controlled SPG therapy. Therapy settings are individualized and can be adjusted quickly by physicians using a programmer laptop.
Clinical data from the Pathway CH-1 Study on the safety and efficacy of the Pulsante System was published in Cephalalgia, a peer-reviewed journal.
The device is inserted through a small incision in the upper gum above the second molar and positioned at the sphenopalatine ganglion (SPG) nerve bundle. The SPG is located deep in the face on either side of the nose. The neurostimulator is placed on the side of the patient’s headache pain. The procedure leaves no visible scars.
The patient controls his or her own stimulation treatment as needed by turning on the Remote Controller and placing it on the cheek over the inserted device. When the patient no longer desires stimulation, the Remote Controller is simply removed from the cheek, turning off stimulation therapy.
If SPG Stimulation Therapy and use of the Pulsante System is no longer needed, the device can be left in place or, if desired, can be removed under local anesthetic in an outpatient procedure.
In a 12 month study of the device’s long term effectiveness[1], researchers concluded:
- 68% (58/85) of patients were therapeutic responders, experiencing at least a 50% attack frequency reduction, acute response, or both.
- Attack frequency was reduced by 44% in the population (p<0.0001), with frequency responders experiencing an 88% reduction.
- Acute Effective Therapy was achieved in 39% of attacks treated in the population, with acute responders achieving Effective Therapy in 86%.
- Acute medications were reduced by 52% in the population (p<0.0001), with therapeutic responders experiencing an 82% reduction.
A 24 month study[2] yielded similarly encouraging results:
- 61% of patients experienced a therapeutic response to SPG stimulation
- 64% of patients experienced clinical improvements in preventive medication use
- 79% of attacks used no acute medications with SPG stimulation
The device is currently in the second part of the clinical study phase. You may be eligible to participate in the Pathway CH-2 Cluster Headache study.
To learn more and find out if you are a candidate, click here.
The Facial Pain Advocacy Alliance does not endorse this or any other medical device.
This post is for informational purposes only.
1. Reduced Pathway Registry 12 Month Interim Results – Long-Term Therapeutic Effectiveness of Sphenopalatine Ganglion Stimulation for Cluster Headache: Mads Barloese,Holger Kaube,Uwe Reuter, Philipp Stude, Andreas Böger, Tim Jürgens, Charly Gaul, Kasja Solbach, Peter Storch, Christian Wöber, Andreas Straube, Oliver Summ, Amy Goodman, Anthony Caparso, Rigmor Jensen, Arne May. Pathway Registry 12 Month Interim Results – Long-Term Therapeutic Effectiveness of Sphenopalatine Ganglion Stimulation for Cluster Headache. (Poster) Presented at the Annual Scientific Meeting of the American Headache Society San Diego United States, June 2016
2. Reduced Medication Use with Sphenopalatine Ganglion (SPG) Stimulation for Cluster Headache: 24 Month Long – Term Follow – Up Results from the Pathway CH-1 Study: Mads Barloese, Rigmor Jensen, Jose Miguel Láinez, Charly Gaul, Jean Schoenen, Amy Goodman, Anthony Caparso, Arne May, Tim Jürgens. Reduced Medication Use with Sphenopalatine Ganglion (SPG) Stimulation for Cluster Headache: 24 Month Long – Term Follow – Up Results from the Pathway CH-1 Study. (Poster) Presented at the European Academy of Neurology Congress, Copenhagen Denmark, May 2016
For further investigation
Long-term effectiveness of sphenopalatine ganglion stimulation for cluster headache: Tim P Jürgens, Mads Barloese, Arne May, Jose Miguel Láinez, Jean Schoenen, Charly Gaul, Amy M Goodman, Anthony Caparso, and Rigmor Højland Jensen
Effectiveness of Sphenopalatine Ganglion (SPG) Stimulation for Cluster Headache: 2 Year Long-Term Follow-Up Results from the Pathway CH-1 Study; 9th EFIC, Wien 2015
Sphenopalatine Ganglion Stimulation in the Pathway CH-1 Study Reduces Headache Burden Before and After Sustained Periods of Cluster Attack Remission; 17th IHC, Valencia 2015.
Effectiveness of Sphenopalatine Ganglion (SPG) Stimulation for Cluster Headache: 2 Year Long-Term Follow-Up Results from the Pathway CH-1 Study; 17th IHC, Valencia 2015.
Therapeutic Effectiveness of Sphenopalatine Ganglion (SPG) Stimulation for Cluster Headache – Pathway Registry Interim Results at 6 Months; 17th IHC, Valencia 2015.
Sphenopalatine Ganglion Stimulation in the Pathway CH-1 Study Reduces Headache Burden Before and After Sustained Periods of Cluster Attack Remission; 9th CONy World Congress, Budapest, March 26th 2015.
Schoenen J, Jensen RH, Lantéri-Minet M, Láinez MJA, Gaul C, Goodman AM, Caparso A, May A. Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: A randomized, sham-controlled study. Cephalalgia. 2013; 33 (10):816-30
Goadsby P. Sphenopalatine (pterygopalatine) ganglion stimulation and cluster headache: New hope for ye who enter here. Cephalalgia. 2013; 33(10) 813–815
Láinez J, Jensen R, May A, Gaul C, Goodman A, Bigazzi O, Caparso A, Schoenen J. Efficacy of Sphenopalatine Ganglion Stimulation in Relieving Acute Cluster Pain: Results from >5000 Attacks during Long-Term Follow-Up of the Pathway CH-1 Study. (Poster) Presented at the European Headache and Migraine Trust International Congress, Copenhagen Denmark, September 2014.
Jürgens T, Jensen R, Kaube H, Böger A, Gaul C, Goodman A, Bigazzi O, Caparso A, May A. Therapeutic Effectiveness of Sphenopalatine Ganglion (SPG) Stimulation for Cluster Headache – Pathway Registry Interim Results at 6 Months. (Poster) Presented at the European Headache and Migraine Trust International Congress, Copenhagen Denmark, September 2014.
Láinez J, Jensen R, Schoenen J, Gaul C, Lantéri-Minet M, Goodman A, Caparso A, May A. Sphenopalatine Ganglion Stimulation (SPGS) for Chronic Cluster Headache (CH) Treatment – Change in Preventive Medication (PM) use at 1 Year in the Pathway CH-1 Study. (Poster) Presented at the American Headache Society Meeting, Los Angeles, CA, USA, June 2014.
Jürgens T, Gaul C, Schoenen J, Jensen R, Láinez JM, Goodman A, Caparso A, May A. Stimulation of the Sphenopalatine Ganglion for Cluster Headache – Pathway CH-1: Sustained Therapeutic Response Through 18 Months. (Poster) Presented at the German Migraine and Headache Society (DMKG) Annual Meeting, Hamburg, Germany, October 2013.
Jürgens T, Gaul C, Schoenen J, Jensen R, Láinez JM, Goodman A, Caparso A, May A. Stimulation of the Sphenopalatine Ganglion for Cluster Headache – Pathway CH-1: Effective Therapy for Acute Cluster Pain during Long-Term Follow-Up. (Poster) Presented at the German Migraine and Headache Society (DMKG) Annual Meeting, Hamburg, Germany, October 2013.
Schoenen J, Jensen R, Lantéri-Minet M, Láinez JM, Gaul C, Goodman A, Caparso A, May A. Stimulation of the Sphenopalatine Ganglion (SPG) for Cluster Headache (CH) Treatment – Pathway CH-1, a Randomized, Sham Controlled Study. (Poster) Presented at the International Headache Congress, Boston, MA, June 2013.
Láinez JM, Schoenen J, Jensen R, Lantéri-Minet M, Gaul C, Goodman A, Caparso A, May A. Stimulation of the Sphenopalatine Ganglion (SPG) for Cluster Headache (CH) Treatment – Pathway CH-1, Impact on Quality of Life (QoL) and Headache Disability. (Poster) Presented at the International Headache Congress, Boston, MA, June 2013.
Weeks I, Ramachandran B, Hard P, Caparso A. Characterization of the Safety of Sphenopalatine Ganglion (SPG) Stimulation using the Autonomic Technologies, Inc. (ATI) Neurostimulation System. (Poster) Presented at the North American Neuromodulation Society (NANS), Las Vegas, NV, 2011