Trial reportEBioMedicine2023
A prospective open label 2-8 year extension of the randomised controlled ICON trial on the long-term efficacy and safety of occipital nerve stimulation in medically intractable chronic cluster headache.
Trial report in EBioMedicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 16 citations in OpenAlex.
- Safety and efficacy of occipital nerve stimulation as treatment of chronic cluster headache: an investigator-initiated, double-blind, randomized, placebo-controlled study.The journal of headache and pain · 2026Trial
- Factors associated with efficacy of occipital nerve stimulation in medically intractable chronic cluster headache.Headache · 2025Trial
- Erenumab for Chronic Cluster Headache: A Randomized Clinical Trial.JAMA network open · 2025Trial
- Predictive factors of effectiveness of occipital nerve stimulation for chronic cluster headache: data from for the French ONS registry.The journal of headache and pain · 2026Article
- Predictors of Response to Occipital Nerve Stimulation in Patients with Refractory Chronic Cluster Headache: Protocol for a Prospective Observational Study.Brain sciences · 2026Article
- Hallmarks of primary headache: part 3 - cluster headache.The journal of headache and pain · 2025Review
- 15. Cluster Headache.Pain practice : the official journal of World Institute of Pain · 2025Review
- Interventional neuromodulation techniques for cervicogenic headache.Journal of anesthesia and translational medicine · 2025Article
- Research hotspots and frontiers of neuromodulation technology in the last decade: a visualization analysis based on the Web of Science database.Frontiers in human neuroscience · 2025Review
- The profile of refractory chronic cluster headache.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025Article
- Multidisciplinary strategies to treat painful mononeuropathies in the upper extremity: from lab to bedside.The Journal of hand surgery, European volume · 2024Review
- Occipital nerve stimulation in medically intractable chronic cluster headache.European journal of neurology · 2024Article
Corrections and comments
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Authors and funding
10 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe demonstrated in the randomised controlled ICON study that 48-week treatment of medically intractable chronic cluster headache (MICCH) with occipital nerve stimulation (ONS) is safe and effective. In L-ICON we prospectively evaluate its long-term effectiveness and safety.
methodsICON participants were enrolled in L-ICON immediately after completing ICON. Therefore, earlier ICON participants could be followed longer than later ones. L-ICON inclusion was stopped after the last ICON participant was enrolled in L-ICON and followed for ≥2 years by completing six-monthly questionnaires on attack frequency, side effects, subjective improvement and whether they would recommend ONS to others. Primary outcome was the change in mean weekly attack frequency 2 years after completion of the ICON study compared to baseline. Missing values for log-transformed attack-frequency were imputed for up to 5 years of follow-up. Descriptive analyses are presented as (pooled) geometric or arithmetic means and 95% confidence intervals.
findingsOf 103 eligible participants, 88 (85%) gave informed consent and 73 (83%) were followed for ≥2 year, 61 (69%) ≥ 3 year, 33 (38%) ≥ 5 years and 3 (3%) ≥ 8.5 years. Mean (±SD) follow-up was 4.2 ± 2.2 years for a total of 370 person years (84% of potentially 442 years). The pooled geometric mean (95% CI) weekly attack frequency remained considerably lower after one (4.2; 2.8-6.3), two (5.1; 3.5-7.6) and five years (4.1; 3.0-5.5) compared to baseline (16.2; 14.4-18.3). Of the 49/88 (56%) ICON ≥50% responders, 35/49 (71%) retained this response and 15/39 (38%) ICON non-responders still became a ≥50% responder for at least half the follow-up period. Most participants (69/88; 78% [0.68-0.86]) reported a subjective improvement from baseline at last follow-up and 70/88 (81% [0.70-0.87]) would recommend ONS to others. Hardware-related surgery was required in 44/88 (50%) participants in 112/122 (92%) events (0.35 person-year
interpretationONS is a safe, well-tolerated and long-term effective treatment for MICCH.
fundingThe Netherlands Organisation for Scientific Research, the Dutch Ministry of Health, the NutsOhra Foundation from the Dutch Health Insurance Companies, and Medtronic.
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