Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: A randomized, sham-controlled study
Jean Schoenen,Rigmor Jensen,Michel Lanteri-Minet,Miguel J. A. Láinez,Charly Gaul,Amy M. Goodman,Anthony Caparso,Arne May +7 more
TLDR
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.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 t...read more
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Neuromodulation of chronic headaches: position statement from the European Headache Federation
Paolo Martelletti,Rigmor Jensen,Andrea Antal,R. Arcioni,Filippo Brighina,Marina de Tommaso,Angelo Franzini,Denys Fontaine,Max Heiland,Tim P Jürgens,Massimo Leone,Delphine Magis,Koen Paemeleire,Stefano Palmisani,Walter Paulus,Arne May +15 more
TL;DR: Any neurostimulation device should only be used in patients with medically intractable syndromes from tertiary headache centers either as part of a valid study or have shown to be effective in such controlled studies with an acceptable side effect profile.
Journal ArticleDOI
Non-invasive Vagus Nerve Stimulation for PREVention and Acute Treatment of Chronic Cluster Headache (PREVA): A Randomised Controlled Study
Charly Gaul,Hans-Christoph Diener,Nicholas Silver,Delphine Magis,Uwe Reuter,Annelie Andersson,Eric Liebler,Andreas Straube +7 more
TL;DR: Adjunctive prophylactic nVNS is a well-tolerated novel treatment for chronic CH, offering clinical benefits beyond those with SoC.
Journal ArticleDOI
Diagnosis, pathophysiology, and management of cluster headache.
Jan Hoffmann,Arne May +1 more
TL;DR: Monoclonal antibodies against calcitonin gene-related peptide, a crucial neurotransmitter of the trigeminal system, are under investigation for the preventive treatment of cluster headache and will increase the understanding of the disorder and perhaps reveal other therapeutic targets.
Journal ArticleDOI
Non-Invasive Vagus Nerve Stimulation for the ACute Treatment of Cluster Headache: Findings From the Randomized, Double-Blind, Sham-Controlled ACT1 Study.
Stephen D. Silberstein,Laszlo L. Mechtler,David Kudrow,Anne H. Calhoun,Candace McClure,Joel R. Saper,Eric Liebler,Emily Rubenstein Engel,Stewart J. Tepper +8 more
TL;DR: To evaluate non‐invasive vagus nerve stimulation (nVNS) as an acute cluster headache treatment, a large number of patients with a history of cluster headache were referred to the clinic for treatment with nVNS.
Journal ArticleDOI
Treatment of Cluster Headache: The American Headache Society Evidence-Based Guidelines.
TL;DR: New evidence‐based treatment guidelines for cluster headache will assist clinicians with identifying and choosing among current treatment options.
References
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Journal ArticleDOI
The International Classification of Headache Disorders: 2nd edition
Journal ArticleDOI
Migraine--current understanding and treatment.
TL;DR: The epidemiology, pathophysiology, and preventive and symptomatic treatment of migraine is described, with special attention to drug therapy with the triptans.
Journal ArticleDOI
The RAND-36 measure of health-related quality of life
Ron D. Hays,Leo S. Morales +1 more
TL;DR: This paper provides example applications of the RAND-36 cross-sectionally and longitudinally, provides information on what a clinically important difference is for the Rand-36 scales, and provides guidance for summarizing theRand-36 in a single number.
Journal ArticleDOI
The unpredictability paradox: review of empirical comparisons of randomised and non-randomised clinical trials
Regina Kunz,Andrew D Oxman +1 more
TL;DR: On average, failure to use randomisation or adequate concealment of allocation resulted in larger estimates of effect due to a poorer prognosis in non-randomlyselected control groups compared with randomly selected control groups.
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