Sphenopalatine ganglion stimulation
see also Sphenopalatine ganglion radiofrequency.
A randomized, sham-controlled study of 32 patients was performed to evaluate further the use of SPG stimulation for the acute treatment of chronic cluster headache. Of the 32 patients, 28 completed the randomized experimental period. Overall, 68% of patients experienced an acute response, a frequency response, or both. In this study the majority of adverse events were related to the implantation procedure, which typically resolved or remained mild in nature at 3 months following the implant procedure. This and other studies highlight the promise of using SPG stimulation to treat the pain-associated cluster headache. SPG stimulation could be a safe and effective option for chronic cluster headache 2).
Pathway CH 1 study
SPG stimulation was performed in 13 patients between 2015 and 2018 in a single center. Lead location was determined by intraoperative computed tomography scan and correlated with the planned lead position as well as clinical data and stimulation parameters. Patients with a reduction of 50% or more in pain intensity or frequency were considered responsive.
Eleven patients (84.6%) responded to SPG stimulation with eight being frequency responders (61.5%). In seven cases, there were less than two electrodes between vidian canal and foramen rotundum, there was no significant correlation with negative stimulation results (p = 0.91). The mean distance of lead location between pre- and postoperative images did not correlate with clinical outcomes (p = 0.84) and was even bigger in responders (4.91 mm vs. 4.53 mm). The closest electrode contact to the vidian canal was in the stimulation area in all but one patient, regardless of its overall distance to canal. The distance of the closest electrode to the vidian canal was, however, not significantly correlated to the percentage of frequency (p = 0.68) or intensity reduction (p = 0.61).
There was no significant correlation regarding aberrations of lead position from the planned position with clinical outcome. However, this study might be underpowered to detect such a correlation. The closest electrode contact to the vidian canal was in the stimulation area in all but one patient in the final programming. This indicates that, overall, the lead location does play a crucial role in SPG stimulation for cluster headache 4).
Thirty-two patients were enrolled and 28 completed the randomized experimental period. Pain relief was achieved in 67.1% of full stimulation-treated attacks compared to 7.4% of sham-treated and 7.3% of sub-perception-treated attacks ( P < 0.0001). Nineteen of 28 (68%) patients experienced a clinically significant improvement: seven (25%) achieved pain relief in ≥50% of treated attacks, 10 (36%), a ≥50% reduction in attack frequency, and two (7%), both. Five SAEs occurred and most patients (81%) experienced transient, mild/moderate loss of sensation within distinct maxillary nerve regions; 65% of events resolved within three months.
On-demand SPG stimulation using the ATI Neurostimulation System is an effective novel therapy for CCH sufferers, with dual beneficial effects, acute pain relief and observed attack prevention, and has an acceptable safety profile compared to similar surgical procedures 5).
A 59-year-old chronic cluster headache (CCH) patient who had side shifts of attacks and was treated with bilateral continuous SPG stimulation. The patient suffered from CCH for 9 years, and the intensity of pain and the frequency of attacks had gradually increased over time. At the time of admission, he experienced daily attacks. Medical therapy and SPG blocks were offered, but he only achieved transient pain relief. After a careful preoperative examination and discussion with the patient, we provided bilateral SPG stimulation. The electrode was implanted under C-arm fluoroscopic guidance. After continuous stimulation, the patient experienced significant reductions in headache severity. The frequency of attacks was reduced from daily to less than once per week. He also discontinued all of the related drugs that he was taking. This is the first report of bilateral continuous SPG stimulation for CCH. This report indicates that continuous SPG stimulation is a feasible therapeutic option for CCH. However, large-scale and long-term studies are required to elucidate the efficacy of SPG stimulation 6).