Use of the Tx360 Nasal Applicator in the Treatment of Chronic Migraine

Summary

Migraine imposes a substantial burden on patients in terms of diminished daily functioning, quality of life, and financial loss. Pain severity and duration correlates with reduced measures of daily functioning, and overall health status. The sphenopalatine ganglion (SPG) has been implicated in a variety of cephalalgias. This has been well represented in the literature dating back over a century. Access to this structure can be gained via a small area of mucosa just posterior and superior to the tail of the middle turbinate on the lateral nasal wall. At this aspect, there is no bony boundary to the SPG. Blocking the SPG using local anesthetics relieves pain. Unfortunately, many current interventions are cumbersome, invasive, and expensive. The purpose of this study is to evaluate the efficacy of the Tx360™, a new nasal applicator device, in the treatment of head and face pain and to examine the economic implications. The Tx360™ is a single use device designed to deliver a topical local anesthetic to the specific area of mucosa associated with the SPG. A total of 42 study participants will be accepted into this double-blind placebo-controlled study. 28 will receive SPG blocks using a 0.3 mL of a 0.5% solution of Marcaine delivered by the Tx360™ while 14 will receive a placebo of saline substituted for the Marcaine. Both patient sets will also be given a piece of lemon hard candy as a taste distractor. Participants must have a chronic migraine history with over 15 symptomatic days per month over the past three months. The treatment plan consists of six weeks of treatment, two times per week. Short and longer term assessments will be retrieved and analyzed as detailed in the Study Design.

Timeline

Start

2012-09

Primary completion

2014-02

Completion

2014-02

Publications

• Background Tepper SJ. A pivotal moment in 50 years of headache history: the first American Migraine Study. Headache. 2008 May;48(5):730-1; discussion 732. doi: 10.1111/j.1526-4610.2008.01117_1.x.
• Background Piagkou M, Demesticha T, Troupis T, Vlasis K, Skandalakis P, Makri A, Mazarakis A, Lappas D, Piagkos G, Johnson EO. The pterygopalatine ganglion and its role in various pain syndromes: from anatomy to clinical practice. Pain Pract. 2012 Jun;12(5):399-412. doi: 10.1111/j.1533-2500.2011.00507.x. Epub 2011 Sep 29.
• Background Oluigbo CO, Makonnen G, Narouze S, Rezai AR. Sphenopalatine ganglion interventions: technical aspects and application. Prog Neurol Surg. 2011;24:171-179. doi: 10.1159/000323049. Epub 2011 Mar 21.
• Background Windsor RE, Jahnke S. Sphenopalatine ganglion blockade: a review and proposed modification of the transnasal technique. Pain Physician. 2004 Apr;7(2):283-6.
• Background Rosenberg M, Phero JC. Regional anesthesia and invasive techniques to manage head and neck pain. Otolaryngol Clin North Am. 2003 Dec;36(6):1201-19. doi: 10.1016/s0030-6665(03)00134-8.
• Background Wood PB. Role of central dopamine in pain and analgesia. Expert Rev Neurother. 2008 May;8(5):781-97. doi: 10.1586/14737175.8.5.781.
• Background Boivie J. Chapter 48 Central post-stroke pain. Handb Clin Neurol. 2006;81:715-30. doi: 10.1016/S0072-9752(06)80052-7. No abstract available.
• Background Stankewitz A, Voit HL, Bingel U, Peschke C, May A. A new trigemino-nociceptive stimulation model for event-related fMRI. Cephalalgia. 2010 Apr;30(4):475-85. doi: 10.1111/j.1468-2982.2009.01968.x. Epub 2010 Feb 1.
• Background Herrera Tolosana S, Fernandez Liesa R, Escolar Castellon Jde D, Perez Delgado L, Lisbona Alquezar MP, Tejero-Garces Galve G, Guallar Larpa M, Ortiz Garcia A. [Sphenopalatinum foramen: an anatomical study]. Acta Otorrinolaringol Esp. 2011 Jul-Aug;62(4):274-8. doi: 10.1016/j.otorri.2011.01.009. Epub 2011 Mar 22. Spanish.
• Background Rusu MC. Microanatomy of the neural scaffold of the pterygopalatine fossa in humans: trigeminovascular projections and trigeminal-autonomic plexuses. Folia Morphol (Warsz). 2010 May;69(2):84-91.
• Background Oomen KP, Ebbeling M, de Ru JA, Hordijk GJ, Bleys RL. A previously undescribed branch of the pterygopalatine ganglion. Am J Rhinol Allergy. 2011 Jan-Feb;25(1):50-3. doi: 10.2500/ajra.2011.25.3550.
• Background Siessere S, Vitti M, Sousa LG, Semprini M, Iyomasa MM, Regalo SC. Anatomic variation of cranial parasympathetic ganglia. Braz Oral Res. 2008 Apr-Jun;22(2):101-5. doi: 10.1590/s1806-83242008000200002.
• Background Gronseth G, Cruccu G, Alksne J, Argoff C, Brainin M, Burchiel K, Nurmikko T, Zakrzewska JM. Practice parameter: the diagnostic evaluation and treatment of trigeminal neuralgia (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology and the European Federation of Neurological Societies. Neurology. 2008 Oct 7;71(15):1183-90. doi: 10.1212/01.wnl.0000326598.83183.04. Epub 2008 Aug 20.
• Background Yang lY, Oraee S. A novel approach to transnasal sphenopalatine ganglion injection. Pain Physician. 2006 Apr;9(2):131-4.
• Background Kanai A, Suzuki A, Kobayashi M, Hoka S. Intranasal lidocaine 8% spray for second-division trigeminal neuralgia. Br J Anaesth. 2006 Oct;97(4):559-63. doi: 10.1093/bja/ael180. Epub 2006 Aug 1.
• Cady RK, Saper J, Dexter K, Cady RJ, Manley HR. Long-term efficacy of a double-blind, placebo-controlled, randomized study for repetitive sphenopalatine blockade with bupivacaine vs. saline with the Tx360 device for treatment of chronic migraine. Headache. 2015 Apr;55(4):529-42. doi: 10.1111/head.12546. Epub 2015 Mar 31.
• Cady R, Saper J, Dexter K, Manley HR. A double-blind, placebo-controlled study of repetitive transnasal sphenopalatine ganglion blockade with tx360((R)) as acute treatment for chronic migraine. Headache. 2015 Jan;55(1):101-16. doi: 10.1111/head.12458. Epub 2014 Oct 23.

Drugs

Indications