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

Author:

Schoenen Jean1,Jensen Rigmor Højland2,Lantéri-Minet Michel3,Láinez Miguel JA4,Gaul Charly5,Goodman Amy M6,Caparso Anthony6,May Arne7

Affiliation:

1. Headache Research Unit, Department of Neurology, CHR Citadelle, Liège University, Belgium

2. Danish Headache Centre, Department of Neurology, Glostrup Hospital, University of Copenhagen, Denmark

3. Département d’Evaluation et Traitement de la Douleur, Pôle Neurosciences Cliniques CHU de Nice, France

4. Department of Neurology, Hospital Clinico Universitario, Universidad Católica de Valencia, Spain

5. Department of Neurology, University Duisburg-Essen, Germany

6. Autonomic Technologies, Inc., CA, USA

7. Department of Systems Neuroscience, Universitäts-Krankenhaus Eppendorf, Germany

Abstract

Background The 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). Methods A 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. Findings 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. Interpretation 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.

Publisher

SAGE Publications

Subject

Clinical Neurology,General Medicine

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