# Drug Free Nerve Block Device for the Relief of Pain and Symptoms in Migraines and other Headaches

> **NIH NIH R44** · THERMAQUIL, INC. · 2022 · $677,548

## Abstract

Abstract:
Migraines and headaches are difficult to treat debilitating neurological conditions that leave physicians and
their patients with few options for sustained relief from severe chronic pain. All available therapies have
considerable side-effects or limitations, leading many patients to resort to drug cocktails including narcotics. To
reduce or eliminate the need to use opiates and systemic pharmaceuticals to treat headaches and migraine,
Thermaquil developed the first noninvasive, drug-free, patient-controlled reversible nerve block device for long
term pain management based on novel mechanisms-of-action that we discovered.
Thermaquil has met with more than 300 physicians and headache patients who have vetted and guided the
development of Thermaquil’s noninvasive nerve block device. The system is designed to easily be used during
normal daily activities. We’ve demonstrated clear efficacy of thermal neuromodulation in single-arm studies
with highly complex patients who have tried and failed all other available treatments. Our 45 participants’
baseline pain of 6.1 ± 1.7 was significantly reduced to 2.6 ± 2.5 ( p < 0.05, p = 6e-12). Most participants have
had constant headache every day over the past 28 days, which would exclude them from most other headache
and migraine clinical trials.
The proposed study begins with a 28-day lead-in phase to establish a baseline for participant headache
frequency, intensity, medications used, other healthcare utilization, and quality of life. After the baseline period,
all participants are randomized into active or control arms and given a single treatment. The study continues
for 12 weeks with active versus control therapy arms before all participants are given active therapy for an
additional 12 weeks. This sham-controlled study will provide evidence of the safety and effectiveness of the
Thermaquil device relieving migraine and headache attacks. Successful completion of the project will 1) justify
the company to pursue a larger efficacy/pivotal trial to move towards regulatory approval and 2) result in
additional investment opportunities for Thermaquil to expedite our clinical program to rapidly bring this product
to market to help stop migraine and other pain for individuals with chronic migraine or other headaches.

## Key facts

- **NIH application ID:** 10493404
- **Project number:** 5R44NS115460-03
- **Recipient organization:** THERMAQUIL, INC.
- **Principal Investigator:** Stephen Popielarski
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $677,548
- **Award type:** 5
- **Project period:** 2020-04-29 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10493404

## Citation

> US National Institutes of Health, RePORTER application 10493404, Drug Free Nerve Block Device for the Relief of Pain and Symptoms in Migraines and other Headaches (5R44NS115460-03). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10493404. Licensed CC0.

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