Trial reportNeurology2025
Kinetic Oscillation Stimulation for the Preventive Treatment of Chronic Migraine: A Randomized, Double-Blind, Sham-Controlled Trial.
Trial report in Neurology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03400059 (A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Efficacy of Intranasal Kinetic Oscillation Stimulation in the Preventive Treatment of Chronic Migraine), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.
What it found
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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.
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.
A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Efficacy of Intranasal Kinetic Oscillation Stimulation in the Preventive Treatment of Chronic Migraine
Who cites it
1 citing paper in PubMed, 1 synthesis or guideline pooled it.
- Effectiveness of neuromodulation techniques for migraine prophylaxis: a systematic review and network meta-analysis of randomized controlled trials.BMC complementary medicine and therapies · 2026Pooled it
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesThe Chordate System administers kinetic oscillation stimulation (K.O.S) into the nasal cavity thereby potentially modulating the activity of trigemino-autonomic reflex. Modulation of this reflex has been proposed as a potential therapeutic target in migraine. The aim of this clinical trial was to evaluate the efficacy of K.O.S for the preventive treatment of chronic migraine (CM).
methodsIn this randomized, double-blind, sham-controlled, multicenter clinical trial, patients with CM were treated with K.O.S once per week over a period of 6 weeks. The primary performance endpoint was the mean change in monthly headache days with moderate to severe intensity (MHDs) from the 28-day pretreatment baseline period to the performance assessment period (days 14-42 of treatment). Mean change from baseline in monthly migraine days (MMDs), proportion of participants with 30% and 50% or greater reduction in moderate to severe headache days compared with baseline, and change in the use of abortive medications from baseline were also assessed during the performance assessment period. Headache-related disability and quality-of-life measures were evaluated up to 70-day posttreatment.
resultsThe primary endpoint showed a significantly larger reduction of MHD across the performance assessment period with active treatment (-3.5 days, n = 67) compared with sham (-1.2 days, n = 65) ( DISCUSSION: The Chordate System provides significant benefits to patients with CM by reducing the number of MHDs. The nonpharmacologic nature of the treatment option positions K.O.S as a valuable addition to the current therapeutic portfolio for the management of CM. TRIAL REGISTRATION INFORMATION: The trial was registered on ClinicalTrials.gov (NCT03400059) on January 17, 2018. The first patient was enrolled on March 22, 2018, and the last patient completed the study on October 1, 2022. The trial registration initially described the timing of the secondary endpoints incorrectly due to clerical error, and this was corrected to match the protocol and analysis plan once discovered. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that weekly intranasal K.O.S is associated with a reduced number of headache days per month in patients with CM.
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