A Feasibility Trial on Intranasal Evaporative Cooling for Acute Migraine in an At-Home Setting

Background: A significant proportion of people with migraine do not achieve sufficient relief of their acute migraine symptoms with the currently available medications. A previous study showed that intranasal evaporative cooling reduced headache and migraine-associated symptoms when given in an outpatient clinic setting. This study aimed to evaluate the feasibility of self-administering the same intervention for acute migraine in an at-home setting. The findings of this study were intended to inform the design and implementation of a planned full-scale randomized controlled trial (RCT).

Methods: We conducted a prospective single-group clinical feasibility trial in southern Sweden. Participants meeting the criteria for episodic migraine, with or without aura, were recruited through local advertisements. After a screening period, during which two migraine attacks were registered and evaluated under usual care, participants treated their next three migraine attacks at home with 10 minutes of intranasal cooling (RhinoChill®, BrainCool AB, Lund, Sweden). The primary outcome was a reduction in headache, nausea, photophobia, and phonophobia immediately after treatment. The secondary outcome was tolerability, and treatment effects within 24 hours.

Results: Six out of 15 participants completed the study, using the cooling treatment for three consecutive migraine attacks. The main reasons for drop-out were pain/discomfort from treatment and lack of effect. A total of 23 treatments were registered by 10 participants. Small effects on pain and other migraine symptoms were observed immediately after treatment. The treatment was considered very unpleasant (Visual Analogue Scale 7.3/10) and not superior to usual care.

Conclusions: The RhinoChill® intranasal cooling treatment at home was found to be non-feasible due to pain and discomfort, resulting in a high drop-out rate. Additionally, it had only minor effects on migraine pain and symptoms. The findings of this study led to the cancellation of a planned full-scale RCT.