Reference : Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Path...
Scientific journals : Article
Human health sciences : Neurology
Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: A randomized, sham-controlled study.
Schoenen, Jean mailto [Université de Liège - ULiège > Département des sciences biomédicales et précliniques > Neuro-anatomie >]
Jensen, Rigmor Hojland [> >]
Lanteri-Minet, Michel [> >]
Lainez, Miguel Ja [> >]
Gaul, Charly [> >]
Goodman, Amy M. [> >]
Caparso, Anthony [> >]
May, Arne [> >]
Blackwell Science
Epub ahead of print
Yes (verified by ORBi)
Osney Mead Oxford
United Kingdom
[en] 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.

File(s) associated to this reference

Fulltext file(s):

Restricted access
stimulation cephalalgia 2013.pdfPublisher postprint438.89 kBRequest copy

Bookmark and Share SFX Query

All documents in ORBi are protected by a user license.