Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: A randomized, sham-controlled study

Abstract

BackgroundThe pain and autonomic symptoms of cluster headache (CH) result from activation of the trigeminal parasympathetic reflex, mediated through the sphenopalatine ganglion (SPG). We investigated the safety and efficacy of on-demand SPG stimulation for chronic CH (CCH).MethodsA multicenter, multiple CH attack study of an implantable on-demand SPG neurostimulator was conducted in patients suffering from refractory CCH. Each CH attack was randomly treated with full, sub-perception, or sham stimulation. Pain relief at 15 minutes following SPG stimulation and device- or procedure-related serious adverse events (SAEs) were evaluated.FindingsThirty-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.InterpretationOn-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.

Neurostimulation in cluster headache: A review of current progress

“…Both these clinical observations and the fact that these patients have had drCCH for years suggest more than a simple placebo effect. However, it is noteworthy that out of all the studies mentioned in this review, only two are randomized and controlled (9,37).…”

“…Searches were performed between summer 2010 and 2012. A single reference, Schoenen et al (9), was changed in January 2013, as full results from a SPGS trial became available.…”

Headache: classification and diagnosis

“…Klinische onderzoeken met neuromodulatie als behandeling van chronische clusterhoofdpijn van de nervus occipitalis major en het ganglion sphenopalatinum vinden momenteel plaats in het Leids Univesitair Medisch Centrum en in het Boerhaave Medisch Centrum/VU medisch centrum in Amsterdam (Burns et al, 2009;Goadsby, 2013;Schoenen et al, 2013). Deze interventionele behandeling van het ganglion sphenopalatinum wordt al meer dan 100 jaar toegepast.…”

Stimulation of the sphenopalatine ganglion in intractable cluster headache: Expert consensus on patient selection and standards of care

“…If nasopharyngeal paresthesias can be evoked, the following issues should be checked: Sensory disturbance. Sensory deficits in the distribution of V2 (including intraoral sensory deficits) were commonly reported ranging from mild hypo-to anaesthesia and resolved or improved dramatically over time (36). Because of their remitting nature, there is usually no need for further action.…”