# Transnasal Cooling to Reduce Pain from Migraine

> **NIH NIH U44** · KEY TECHNOLOGIES, INC. · 2020 · $1,113,875

## Abstract

Migraine is a severely disabling neurologic condition and is the sixth most disabling disorder worldwide,
affecting over a billion people. The prevalence of migraine in the U.S. is increasing, with 15% of the
population suffering from either episodic or chronic migraine, and women are three times more likely to
be affected than men. The global economic burden of migraine is staggering at approximately $20
billion in the U.S. and $56 billion worldwide per year. Migraine is also one of the most common reasons
for emergency room visits. Despite treatment recommendations, many migraine patients are still
prescribed opioid pain medications, particularly in emergency departments (EDs). One study found that
opioids were prescribed at 69% of community ED visits, 41% of urban ED visits, and 12% of academic
medical center visits. It is evident that opioid prescriptions for migraine are contributing significantly to
the growing opioid epidemic. Overall, current therapies for migraine are suboptimal, expensive and
ineffective in curbing the global opioid epidemic. There is an enormous unmet need for an effective
and affordable non-drug abortive therapy for acute migraine to significantly improve quality of life
and substantially reduce the cost burden to our healthcare system and society.
We are developing a novel approach to migraine treatment that is simple, safe, and drug free, using
nothing but clean, dry air. Our approach targets the sphenopalatine ganglion (SPG), a nerve bundle
behind the upper airway that is implicated in the onset of migraine headaches. Preliminary evidence
has shown that SPG blocks using lidocaine or cold temperatures can inhibit activity from this nerve
bundle, reducing the pain and duration of migraines. The location of the SPG behind the nose makes it
hard to access. We believe transnasal cooling is an approach that can alleviate this problem, providing
fast, convenient, drug-free cooling and pain relief for migraineurs. Feasibility testing with one of our
prototypes showed significant pain relief in those with migraines compared to sham.
The scope of work from this grant will create, test and validate a clinical-grade version of a new device
that we are calling the ‘Mi-Helper’. The device will be designed, tested and documented with full design
controls sufficient to satisfy FDA 21 CFR 820.30. We will also collect clinical data through two FDA
approved human trials to demonstrate the safety, efficacy and usability for using our transnasal cooling
approach for treating migraine pain, without the use of drugs or opioids. This work will set the stage for
the next step of obtaining FDA clearance and initiating commercialization of the final product.

## Key facts

- **NIH application ID:** 10113157
- **Project number:** 1U44NS119974-01
- **Recipient organization:** KEY TECHNOLOGIES, INC.
- **Principal Investigator:** BENJAMIN R LANE
- **Activity code:** U44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,113,875
- **Award type:** 1
- **Project period:** 2020-09-30 → 2023-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10113157

## Citation

> US National Institutes of Health, RePORTER application 10113157, Transnasal Cooling to Reduce Pain from Migraine (1U44NS119974-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10113157. Licensed CC0.

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