Long-term effectiveness of sphenopalatine ganglion stimulation for cluster headache

Tim P Jürgens; Mads Barloese; Arne May; Jose Miguel Láinez; Jean Schoenen; Charly Gaul; Amy M Goodman; Anthony Caparso; Rigmor Højland Jensen

doi:10.1177/0333102416649092

Long-term effectiveness of sphenopalatine ganglion stimulation for cluster headache

Tim P Jürgens, Mads Barloese, Arne May, Jose Miguel Láinez, Jean Schoenen, Charly Gaul, Amy M Goodman, Anthony Caparso, Rigmor Højland Jensen

Department of Clinical Medicine

63 Citations (Scopus)

52 Downloads (Pure)

Abstract

Objectives The sphenopalatine ganglion (SPG) plays a pivotal role in cluster headache (CH) pathophysiology as the major efferent parasympathetic relay. We evaluated the long-term effectiveness of SPG stimulation in medically refractory, chronic CH patients. Methods Thirty-three patients were enrolled in an open-label follow-up study of the original Pathway CH-1 study, and participated through 24 months post-insertion of a microstimulator. Response to therapy was defined as acute effectiveness in ≥ 50% of attacks or a ≥ 50% reduction in attack frequency versus baseline. Results In total, 5956 attacks (180.5 ± 344.8, range 2-1581 per patient) were evaluated. At 24 months, 45% ( n = 15) of patients were acute responders. Among acute responders, a total of 4340 attacks had been treated, and in 78% of these, effective therapy was achieved using only SPG stimulation (relief from moderate or greater pain or freedom from mild pain or greater). A frequency response was observed in 33% ( n = 11) of patients with a mean reduction of attack frequency of 83% versus baseline. In total, 61% (20/33) of all patients were either acute or frequency responders or both. The majority maintained their therapeutic response through the 24-month evaluation. Conclusions In the population of disabled, medically refractory chronic CH patients treated in this study, SPG stimulation is an effective acute therapy in 45% of patients, offering sustained effectiveness over 24 months of observation. In addition, a maintained, clinically relevant reduction of attack frequency was observed in a third of patients. These long-term data provide support for the use of SPG stimulation for disabled patients and should be considered after medical treatments fail, are not tolerated or are inconvenient for the patients.

Original language	English
Journal	Cephalalgia : an international journal of headache
Volume	37
Issue number	5
Pages (from-to)	423-434
ISSN	0333-1024
DOIs	https://doi.org/10.1177/0333102416649092
Publication status	Published - 1 Apr 2017

Keywords

Adult
Aged
Cluster Headache/diagnosis
Cohort Studies
Electric Stimulation Therapy/instrumentation
Female
Follow-Up Studies
Ganglia, Parasympathetic/physiology
Humans
Implantable Neurostimulators/trends
Male
Middle Aged
Prospective Studies
Time Factors
Treatment Outcome

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10.1177/0333102416649092Licence: CC BY-NC

0333102416649092Final published version, 650 KBLicence: CC BY-NC

Cite this

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title = "Long-term effectiveness of sphenopalatine ganglion stimulation for cluster headache",

abstract = "Objectives The sphenopalatine ganglion (SPG) plays a pivotal role in cluster headache (CH) pathophysiology as the major efferent parasympathetic relay. We evaluated the long-term effectiveness of SPG stimulation in medically refractory, chronic CH patients. Methods Thirty-three patients were enrolled in an open-label follow-up study of the original Pathway CH-1 study, and participated through 24 months post-insertion of a microstimulator. Response to therapy was defined as acute effectiveness in ≥ 50% of attacks or a ≥ 50% reduction in attack frequency versus baseline. Results In total, 5956 attacks (180.5 ± 344.8, range 2-1581 per patient) were evaluated. At 24 months, 45% ( n = 15) of patients were acute responders. Among acute responders, a total of 4340 attacks had been treated, and in 78% of these, effective therapy was achieved using only SPG stimulation (relief from moderate or greater pain or freedom from mild pain or greater). A frequency response was observed in 33% ( n = 11) of patients with a mean reduction of attack frequency of 83% versus baseline. In total, 61% (20/33) of all patients were either acute or frequency responders or both. The majority maintained their therapeutic response through the 24-month evaluation. Conclusions In the population of disabled, medically refractory chronic CH patients treated in this study, SPG stimulation is an effective acute therapy in 45% of patients, offering sustained effectiveness over 24 months of observation. In addition, a maintained, clinically relevant reduction of attack frequency was observed in a third of patients. These long-term data provide support for the use of SPG stimulation for disabled patients and should be considered after medical treatments fail, are not tolerated or are inconvenient for the patients.",

keywords = "Adult, Aged, Cluster Headache/diagnosis, Cohort Studies, Electric Stimulation Therapy/instrumentation, Female, Follow-Up Studies, Ganglia, Parasympathetic/physiology, Humans, Implantable Neurostimulators/trends, Male, Middle Aged, Prospective Studies, Time Factors, Treatment Outcome",

author = "J{\"u}rgens, {Tim P} and Mads Barloese and Arne May and L{\'a}inez, {Jose Miguel} and Jean Schoenen and Charly Gaul and Goodman, {Amy M} and Anthony Caparso and Jensen, {Rigmor H{\o}jland}",

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doi = "10.1177/0333102416649092",

language = "English",

volume = "37",

pages = "423--434",

journal = "Cephalalgia : an international journal of headache",

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TY - JOUR

T1 - Long-term effectiveness of sphenopalatine ganglion stimulation for cluster headache

AU - Jürgens, Tim P

AU - Barloese, Mads

AU - May, Arne

AU - Láinez, Jose Miguel

AU - Schoenen, Jean

AU - Gaul, Charly

AU - Goodman, Amy M

AU - Caparso, Anthony

AU - Jensen, Rigmor Højland

PY - 2017/4/1

Y1 - 2017/4/1

N2 - Objectives The sphenopalatine ganglion (SPG) plays a pivotal role in cluster headache (CH) pathophysiology as the major efferent parasympathetic relay. We evaluated the long-term effectiveness of SPG stimulation in medically refractory, chronic CH patients. Methods Thirty-three patients were enrolled in an open-label follow-up study of the original Pathway CH-1 study, and participated through 24 months post-insertion of a microstimulator. Response to therapy was defined as acute effectiveness in ≥ 50% of attacks or a ≥ 50% reduction in attack frequency versus baseline. Results In total, 5956 attacks (180.5 ± 344.8, range 2-1581 per patient) were evaluated. At 24 months, 45% ( n = 15) of patients were acute responders. Among acute responders, a total of 4340 attacks had been treated, and in 78% of these, effective therapy was achieved using only SPG stimulation (relief from moderate or greater pain or freedom from mild pain or greater). A frequency response was observed in 33% ( n = 11) of patients with a mean reduction of attack frequency of 83% versus baseline. In total, 61% (20/33) of all patients were either acute or frequency responders or both. The majority maintained their therapeutic response through the 24-month evaluation. Conclusions In the population of disabled, medically refractory chronic CH patients treated in this study, SPG stimulation is an effective acute therapy in 45% of patients, offering sustained effectiveness over 24 months of observation. In addition, a maintained, clinically relevant reduction of attack frequency was observed in a third of patients. These long-term data provide support for the use of SPG stimulation for disabled patients and should be considered after medical treatments fail, are not tolerated or are inconvenient for the patients.

AB - Objectives The sphenopalatine ganglion (SPG) plays a pivotal role in cluster headache (CH) pathophysiology as the major efferent parasympathetic relay. We evaluated the long-term effectiveness of SPG stimulation in medically refractory, chronic CH patients. Methods Thirty-three patients were enrolled in an open-label follow-up study of the original Pathway CH-1 study, and participated through 24 months post-insertion of a microstimulator. Response to therapy was defined as acute effectiveness in ≥ 50% of attacks or a ≥ 50% reduction in attack frequency versus baseline. Results In total, 5956 attacks (180.5 ± 344.8, range 2-1581 per patient) were evaluated. At 24 months, 45% ( n = 15) of patients were acute responders. Among acute responders, a total of 4340 attacks had been treated, and in 78% of these, effective therapy was achieved using only SPG stimulation (relief from moderate or greater pain or freedom from mild pain or greater). A frequency response was observed in 33% ( n = 11) of patients with a mean reduction of attack frequency of 83% versus baseline. In total, 61% (20/33) of all patients were either acute or frequency responders or both. The majority maintained their therapeutic response through the 24-month evaluation. Conclusions In the population of disabled, medically refractory chronic CH patients treated in this study, SPG stimulation is an effective acute therapy in 45% of patients, offering sustained effectiveness over 24 months of observation. In addition, a maintained, clinically relevant reduction of attack frequency was observed in a third of patients. These long-term data provide support for the use of SPG stimulation for disabled patients and should be considered after medical treatments fail, are not tolerated or are inconvenient for the patients.

KW - Adult

KW - Aged

KW - Cluster Headache/diagnosis

KW - Cohort Studies

KW - Electric Stimulation Therapy/instrumentation

KW - Female

KW - Follow-Up Studies

KW - Ganglia, Parasympathetic/physiology

KW - Humans

KW - Implantable Neurostimulators/trends

KW - Male

KW - Middle Aged

KW - Prospective Studies

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1177/0333102416649092

DO - 10.1177/0333102416649092

M3 - Journal article

C2 - 27165493

SN - 0333-1024

VL - 37

SP - 423

EP - 434

JO - Cephalalgia : an international journal of headache

JF - Cephalalgia : an international journal of headache

IS - 5

ER -

Long-term effectiveness of sphenopalatine ganglion stimulation for cluster headache

Abstract

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