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Abstract
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Background and Aims The sphenopalatine ganglion (SPG) is a well described therapeutical target to treat primary headaches (migraine, tension headache, cluster headache and other primary headache disorders). Until recently, electrical neurostimulation of the SPG required invasive approaches. We described here a case series of non-invasive intranasal neurostimulation of the SPG.
Methods Patients with primary headache disorders and failed multiple pharmacological treatments were selected for low frequency intra-nasal non-invasive neuromodulation of the SPG, using the Remedius ExStim neurostimulator and Remedius nasal catheter (10-minute weekly session, frequency of 2Hz and amplitude determined by feedback from the patient of a comfortable pulsing sensation felt over the maxillary region of the face).
Results 26 patients (21F/5M, mean age 49) were enrolled: 12 migraines, 6 tension headaches, 3 cluster headaches and 5 other primary headache disorders. The mean duration of symptom was 15 years. The average number of sessions was 5. Changes from baseline to post-treatment scores were respectively 0.225 to 0.864 for EQ-5D-5L index and 14.3 to 86.5 for EQ-5D-5L VAS. The EQ-5D-5L index at the latest follow-up (mean duration of 72 months) was 0.855. Patient global impression of changes (PGIC) at the latest follow-up was 7 in 12 patients, 6 in 7, 5 in 3, 4 in 2 and 3 in 2 (mean PGIC 6,5). Results are summarized in figure 1.
Results
Conclusions The case series corroborated the efficacy of a new non-invasive neurostimulation approach targeting the SPG for management of refractory primary headaches. Quality of life and PGIC were drastically improved and maintained over time.