A new device to treat chronic migraines

The Chordate System, using a technique called Kinetic Oscillation Stimulation (K.O.S), has shown promising results in reducing monthly headache days for people with chronic migraines, according to a study just published by European neurologists in the journal Neurology.

The treatment involves gentle stimulation inside the nasal cavity using a specialized catheter that delivers precise pressure and vibrations. Each session lasts 10 minutes per nostril and is administered weekly. The device works by potentially modulating the trigeminal nerve pathways involved in migraine attacks.

Study design: The study was randomized, double-blind, and sham-controlled.

Participants: Patients with chronic migraine (defined as headaches occurring on 15 or more days per month, with at least 8 of those being migraine days). The active treatment was given to 67 patients and the sham to 65.

Treatment: Weekly K.O.S sessions for six weeks.

Primary Endpoint: Change in monthly headache days with moderate to severe intensity (MHDs) from baseline to the performance assessment period (days 14–42).

Secondary Endpoints: These included changes in monthly migraine days (MMDs), reductions in headache severity, use of abortive medications, and improvements in quality of life.

Key Findings

The results demonstrated that K.O.S provided significant benefits for patients with chronic migraine:

Reduction in Monthly Headache Days (MHDs):

Active treatment resulted in a reduction of 3.5 MHDs during the assessment period, compared to a 1.2-day reduction with sham treatment.

This improvement persisted into the follow-up period, with a 2.7-day reduction in MHDs compared to sham.

Reduction in Monthly Migraine Days (MMDs):

Patients receiving K.O.S experienced a 2.4-day reduction in MMDs during the assessment period with effects lasting into follow-up (2.9 days).

Responder Rates:

A significant proportion of participants achieved a 30% or 50% reduction in moderate-to-severe headache days, demonstrating the clinical relevance of K.O.S.

Safety Profile:

Adverse events were mild and similar between the active and sham groups, with nasopharyngitis, dizziness, and minor nosebleeds being the most common. Importantly, no treatment-related serious adverse events were observed.

This non-drug approach offers a new option for people suffering from chronic migraines, especially those concerned about medication side effects. The treatment’s effectiveness is comparable to current standard medications while offering a non-pharmaceutical alternative.

The Chordate System (Ozilia) is not currently available in the United States, as it has not yet received FDA approval. However, the company, Chordate Medical, is actively working toward getting it approved.

We do have several FDA-approved devices to treat migraines. The most effective, practical, and affordable are Cefaly and Nerivio. Relivion, Savi Dual, and gammaCore are less so.