Kinetic Oscillation Stimulation Significantly Reduces Monthly Headache Days in Chronic Migraine

Emilia Tauriala, MD

Findings from a subgroup analysis investigating kinetic oscillation stimulation showed that the treatment potential might be an effective and safe option for preventing chronic migraine.

In recent news, primary results from a subgroup analysis of the randomized, controlled PM007 study (NCT03400059) showed that patients who received kinetic oscillation stimulation (KOS) treatment with the Chordate System S211 had a significant reduction in the number of monthly headache days (MHDs) compared with sham treatment.1 These findings, presented at the 2023 American Headache Society (AHS) Annual Meeting, June 15-18, in Austin, Texas, suggest that KOS is an effective and safe treatment for patients who experience chronic migraine.

In the ANCOVA analysis, the difference demonstrated by the least-squares (LS) mean between the 4-week baseline period and the 3- to 6-week treatment period was –2.23 MHD (95% CI, –3.95 to –0.51; P = .0132). Notably, results from the 4-week follow-up period after 6 weeks of stimulation showed a reduction of LS by –2.68 MHD (95% CI, –4.32 to –1.04; P = .0014), hence showing a maintained improvement during that period. The results confirmed findings from the German part of PM007 that was presented at the 2022 Migraine Trust International Symposium, held September 8 to 11, in London, England.

"The findings of the randomized, sham-controlled clinical trial show that intranasal KOS is an effective and safe option for the preventive treatment of chronic migraine,” coauthor Emilia Tauriala, MD, a neurologist and the chief medical officer at Terveystalo, and colleagues wrote.¹ “The nonpharmacological nature of the treatment option positions KOS as a valuable addition to the current therapeutic portfolio for the management of chronic migraine as beyond having a solid and sustained treatment effect, it stands out from other preventive treatments by its favorable adverse effect profile.”

The PM007 study enrolled 132 patients with a diagnosis of chronic migraine (defined as 15 days per month with headache, of which at least 8 days were with migraine) and was performed at 9 neurological clinics, 5 in Germany and 4 in Finland. The study's primary efficacy end point was detecting the average change from baseline (4-week screening period, 4-week follow-up period) of MHDs with moderate to severe intensity, after weekly treatments for 6 weeks. Sixty-seven patients received active KOS treatment from the study equipment, and 65 patients were given a validated sham/placebo treatment from the same equipment.

“The fact that AHS invites the researchers in the study to present the study results in a lecture format confirms the importance of the study results, which show that KOS has a significant clear effect for the preventive treatment of chronic migraine. We see the customary publication of the abstract as very positive because it will contribute to the knowledge about the treatment method spreading faster both in the US and the rest of the world. As a sponsor of a study, we have no influence over, nor control of, such occurrence,” Anders Weilandt, CEO of Chordate Medical said in a statement.¹

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REFERENCES
1. Chordate announces that the American Headache Society has accepted a presentation of the final results of the PM007 study at the AHS-congress in June 2023. News Release. Chordate Medical. April 13, 2023. Accessed June 14, 2023. https://www.chordate.com/mfn_news/chordate-announces-that-the-american-headache-society-has-accepted-a-presentation-of-the-final-results-of-the-pm007-study-at-the-ahs-congress-in-june-2023/