Larry Charleston IV1, Amaal J. Starling2, Nauman Tariq3
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1Michigan State University, East Lansing, MI; 2Mayo Clinic, Scottsdale, AZ; 3Atrium Health Neurosciences Institute, Charlotte, NC
Objective
To evaluate the safety, tolerability, and optimal dose of a novel drug-free thermodynamic neuromodulation device–for acute treatment of migraine.
Background
- The pathophysiology of migraine is complex and not fully understood.
- There is evidence that the headache phase of migraine is caused by the activation of nociceptors in the trigeminal ganglion.
- The sphenopalatine ganglion (SPG), a large ganglion located behind the superior nasal turbinate, is closely associated with the trigeminal system.
- Transnasal evaporative cooling may abort migraine through modulation of the sphenopalatine ganglion
Methods of Study & Design
- Randomized, double-blind, study at 3 sites in the US.
- 87 adults with episodic migraine with or without aura were enrolled. Subjects returned to the clinic for a 15-minute treatment during an acute migraine attack.
- 24 subjects were randomized in a 1:1:1 ratio to 3 groups: 24 liters per minute (LPM), 18 LPM, and 6 LPM.
- Pain levels and most bothersome symptoms (MBS) were recorded at baseline, 2-, and 24 hours.
- The primary endpoint was pain relief at 2 hours.
- Secondary endpoints included tolerability, Most Bothersome Symptom (MBS) relief & pain freedom at 2 hours.
Results
- 88% of the 6LPM group had pain relief at 2hrs without rescue medication (woRM).
- 44% of the 6LPM group had pain freedom at 2hrs woRM.
- Pain relief at 2 hours woRM was reported by 44% and 50% in the 18LPM and 24LPM groups, respectively.
- MBS relief was reported at 2 hours by 77% of the 6LPM group.
- MBS relief at 2hrs was reported by 66% and 50% of the 18LPM and 24LPM groups, respectively.
- There were no adverse events in the 6LPM group. No adverse events reported in the 18LPM or 24LPM groups were serious or severe.
- The study was terminated due to an insufficient subject accrual rate.
Key Points
- Both tolerability & efficacy outcomes decreased as the dose (flow rate LPM) increased.
- The lowest flow rate (6LPM) was highly tolerated & showed significant relief from pain & MBS at 2 hours
Conclusion
Transnasal cooling at lower flow rates is effective and tolerable for treating acute migraines. This data will help in dose-ranging analysis to inform future studies.
Next Steps
Decentralized study with new at-home Mi-Helper device starting this August.