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

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Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: a randomized, sham-controlled study. / Schoenen, Jean; Jensen, Rigmor Højland; Lantéri-Minet, Michel; Láinez, Miguel J A; Gaul, Charly; Goodman, Amy M; Caparso, Anthony; May, Arne.

In: CEPHALALGIA, Vol. 33, No. 10, 01.07.2013, p. 816-30.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Schoenen, J, Jensen, RH, Lantéri-Minet, M, Láinez, MJA, Gaul, C, Goodman, AM, Caparso, A & May, A 2013, 'Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: a randomized, sham-controlled study', CEPHALALGIA, vol. 33, no. 10, pp. 816-30. https://doi.org/10.1177/0333102412473667

APA

Schoenen, J., Jensen, R. H., Lantéri-Minet, M., Láinez, M. J. A., Gaul, C., Goodman, A. M., Caparso, A., & May, A. (2013). Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: a randomized, sham-controlled study. CEPHALALGIA, 33(10), 816-30. https://doi.org/10.1177/0333102412473667

Vancouver

Schoenen J, Jensen RH, Lantéri-Minet M, Láinez MJA, Gaul C, Goodman AM et al. Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: a randomized, sham-controlled study. CEPHALALGIA. 2013 Jul 1;33(10):816-30. https://doi.org/10.1177/0333102412473667

Bibtex

@article{04f3353b211d4412bedfab01ff945438,
title = "Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: a randomized, sham-controlled study",
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.",
keywords = "Adolescent, Adult, Aged, Cluster Headache, Electric Stimulation Therapy, Electrodes, Implanted, Female, Ganglia, Parasympathetic, Humans, Male, Microelectrodes, Middle Aged, Pain Measurement, Pterygopalatine Fossa, Treatment Outcome, Young Adult",
author = "Jean Schoenen and Jensen, {Rigmor H{\o}jland} and Michel Lant{\'e}ri-Minet and L{\'a}inez, {Miguel J A} and Charly Gaul and Goodman, {Amy M} and Anthony Caparso and Arne May",
year = "2013",
month = jul,
day = "1",
doi = "10.1177/0333102412473667",
language = "English",
volume = "33",
pages = "816--30",
journal = "CEPHALALGIA",
issn = "0333-1024",
publisher = "SAGE Publications",
number = "10",

}

RIS

TY - JOUR

T1 - Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: a randomized, sham-controlled study

AU - Schoenen, Jean

AU - Jensen, Rigmor Højland

AU - Lantéri-Minet, Michel

AU - Láinez, Miguel J A

AU - Gaul, Charly

AU - Goodman, Amy M

AU - Caparso, Anthony

AU - May, Arne

PY - 2013/7/1

Y1 - 2013/7/1

N2 - 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.

AB - 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.

KW - Adolescent

KW - Adult

KW - Aged

KW - Cluster Headache

KW - Electric Stimulation Therapy

KW - Electrodes, Implanted

KW - Female

KW - Ganglia, Parasympathetic

KW - Humans

KW - Male

KW - Microelectrodes

KW - Middle Aged

KW - Pain Measurement

KW - Pterygopalatine Fossa

KW - Treatment Outcome

KW - Young Adult

U2 - 10.1177/0333102412473667

DO - 10.1177/0333102412473667

M3 - SCORING: Journal article

C2 - 23314784

VL - 33

SP - 816

EP - 830

JO - CEPHALALGIA

JF - CEPHALALGIA

SN - 0333-1024

IS - 10

ER -