Evidence map›Paper›PMID 27461394›Full record

Trial reportThe journal of headache and pain2016

Cluster headache attack remission with sphenopalatine ganglion stimulation: experiences in chronic cluster headache patients through 24 months.

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

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The journal of headache and pain, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03567590 (A Prospective, Multicentre, Randomized, Controlled, Blinded-endpoint Study to Evaluate the Efficacy and Safety of Sphenopalatine Ganglion Pulsed Radiofrequency Treatment for Cluster Headache), which is not on this map. Cited by 19 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 3 pooled it
8.2field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03567590 nacompletednot on this mapstarted 2018, after this paper: background citation

A Prospective, Multicentre, Randomized, Controlled, Blinded-endpoint Study to Evaluate the Efficacy and Safety of Sphenopalatine Ganglion Pulsed Radiofrequency Treatment for Cluster Headache

TypeinterventionalSponsorBeijing Tiantan HospitalRan2018 to 2021Enrolled80ConditionsCluster HeadacheArmsPulsed Radiofrequency treatment, Nerve Block treatment
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 58 citations in OpenAlex.

  1. Pooled it
  2. Cluster headache: crosspoint between otologists and neurologists-treatment of the sphenopalatine ganglion and systematic review.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2019
    Pooled it
  3. Pooled it
  4. Hallmarks of primary headache: part 3 - cluster headache.The journal of headache and pain · 2025
    Review
  5. Review
  6. Review
  7. Cluster headache: state of the art in treatment.Frontiers in pain research (Lausanne, Switzerland) · 2023
    Review
  8. Review
  9. Review
  10. Migraine: Experimental Models and Novel Therapeutic Approaches.International journal of molecular sciences · 2019
    Review
  11. Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. A new era in headache treatment.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2018
    Review
  17. Treatment of the Patient with Refractory Headache.Current pain and headache reports · 2018
    Review
  18. Article
  19. New treatments for headache.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2017
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 4 countries.

Mads C J BarloeseDanish Headache Centre, Department of Neurology, Rigshospitalet-Glostrup, University of Copenhagen, Copenhagen, Denmark. mads.christian.johannes.barloese@regionh.dk.ORCID http://orcid.org/0000-0003-1046-2586
Tim P JürgensDepartment of Neurology, University Medical Center Rostock, Rostock, Germany.
Arne MayDepartment of Systems Neuroscience, University Medical-Center Hamburg-Eppendorf, Hamburg, Germany.
Jose Miguel LainezDepartment of Neurology, Hospital Clinico Universitario, Universidad Católica de Valencia, Valencia, Spain.
Jean SchoenenHeadache Research Unit. Department of Neurology - CHR Citadelle, Liège University, Liège, Belgium.
Charly GaulMigraine- and Headache Clinic Königstein, Königstein, Germany.
Amy M GoodmanClinical Research, Autonomic Technologies, Redwood City, California, USA.
Anthony CaparsoClinical Research, Autonomic Technologies, Redwood City, California, USA.
Rigmor Højland JensenDanish Headache Centre, Department of Neurology, Rigshospitalet-Glostrup, University of Copenhagen, Copenhagen, Denmark.
Universität Hamburg · DEUniversity of Copenhagen · DKCentre hospitalier régional de la Citadelle · BEHospital Clínico Universitario de Valencia · ESMigräne Klinik Königstein · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCluster headache (CH) is a debilitating headache disorder with severe consequences for patient quality of life. On-demand neuromodulation targeting the sphenopalatine ganglion (SPG) is effective in treating the acute pain and a subgroup of patients experience a decreased frequency of CH attacks.

methodsWe monitored self-reported attack frequency, headache disability, and medication intake in 33 patients with medically refractory, chronic CH (CCH) in an open label follow-up study of the original Pathway CH-1 study. Patients were followed for at least 24 months (average 750 ± 34 days, range 699-847) after insertion of an SPG microstimulator. Remission periods (attack-free periods exceeding one month, per the ICHD 3 (beta) definition) occurring during the 24-month study period were characterized. Attack frequency, acute effectiveness, medication usage, and questionnaire data were collected at regular clinic visits. The time point "after remission" was defined as the first visit after the end of the remission period.

resultsThirty percent (10/33) of enrolled patients experienced at least one period of complete attack remission. All remission periods followed the start of SPG stimulation, with the first period beginning 134 ± 86 (range 21-272) days after initiation of stimulation. On average, each patient's longest remission period lasted 149 ± 97 (range 62-322) days. The ability to treat acute attacks before and after remission was similar (37 % ± 25 % before, 49 % ± 32 % after; p = 0.2188). Post-remission headache disability (HIT-6) was significantly improved versus baseline (67.7 ± 6.0 before, 55.2 ± 11.4 after; p = 0.0118). Six of the 10 remission patients experienced clinical improvements in their preventive medication use. At 24 months post insertion headache disability improvements remained and patient satisfaction measures were positive in 100 % (10/10).

conclusionsIn this population of 33 refractory CCH patients, in addition to providing the ability to treat acute attacks, neuromodulation of the SPG induced periods of remission from cluster attacks in a subset of these. Some patients experiencing remission were also able to reduce or stop their preventive medication and remissions were accompanied by an improvement in headache disability.

Indexed as

Ganglia, ParasympatheticAdultCluster HeadacheElectric Stimulation TherapyFemaleFollow-Up StudiesHeadache DisordersHumansMaleMiddle AgedQuality of LifeRemission InductionTime FactorsCluster headacheNeuromodulationNeurostimulationRemissionSphenopalatine ganglion

Identifiers

PMID27461394
PMCPMC4961666
OpenAlexW2479826167

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.