Nasal Cavity Cooling for the Symptomatic Relief of Migraine Headache - a Pilot Study

The aim of the study is to evaluate the effect of self-administered intranasal cooling for the symptomatic relief of migraine headache and associated symptoms in an "at home setting".

10-20 patients - who have been diagnosed according to the International Classification of Headache disorders (2nd Edition) criteria for Episodic migraine, with or without aura - will be included in the study.

During a screening period of one month participants will record their migraine symptoms, any treatment and treatment effects. After a minimum om two migraine attacks the participants receive individual instructions on how to use the The RhinoChill® system. During the following treatment period of the study, participants are instructed to treat their upcoming three migraine attacks with 10 minutes of nasal cavity cooling according to the instructions and thereby register symptoms and treatment effects after 10 minutes, 1 hour, 2 hours, 24 hours and 48 hours.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Device: Nasal cavity cooling device.

Detailed Description

Mechanical techniques to alleviate migraine symptoms have been used for many years, cooling and compression being the most frequently applied. Cryotherapy is the most common non-pharmacological self-administered pain-relieving method currently used by migraine sufferers.

The RhinoChill® System is a CE-Marked device that is currently commercially available in Europe. The RhinoChill® device is intended for temperature reduction in patients via the nasal cavity and can be used across a range of medical and surgical indications where reduction in patient temperature is required. The RhinoChill® system was originally designed specifically for use in the pre-hospital, in-hospital, in-clinic or other clinical settings for the induction of therapeutic hypothermia (reduction in brain and body temperature to between 32-34oC), in which other commercial cooling systems are not practical for use. The RhinoChill® system is portable and runs on batteries. The system cools by spraying an evaporative coolant into the nasal cavity via intranasal catheters. A previous study has shown that the use of RhinoChill® intranasal cooling within a clinic environment provided a statistically significant reduction of pain and associated symptoms of migraine at 5 and 10 minutes (during treatment) and at 1 and 2 hours following treatment along with significant effect on pain and symptoms at 24 hours (all p values <0.001).

The aim of the study is to evaluate the effect of intranasal cooling for the symptomatic relief of migraine headache and associated symptoms when the treatment is self-administered by the patient at home.

The proposed study will be single group assignment with treatment self-administered by patients in their own home, with support and oversight from research support staff working under the direction of the investigators.

The study process is as summarized:

Participants will be identified through adverts at Lund University and are able to register interest via telephone or email. They are then contacted by a researcher by telephone for a brief eligibility check and to book a first meeting at the Braincool office.

Meeting 1, at Braincool office (researcher and research support team):

• Eligibility check - stage one (Case Report Form 1)
• Trial information, viewing of device and catheter
• Informed Consent Form complete
• Instruction on how to register migraine attack symptoms and treatment effects in application/CRF2.

Screening period starts. When the participant has registered two migraine attacks during the screeing period the next meeting is booked:

Meeting 2, home visit (research support team):

o Training on how to use the RhinoChill® device safely and how to register migraine symptoms and treatment effects in application/CRF 3

During the following treatment period of the study, participants are instructed to treat their upcoming three migraine attacks with 10 minutes of nasal cavity cooling according to the instructions and thereby register symptoms and treatment effects after 10 minutes, 1 hour, 2 hours, 24 hours and 48 hours.

When the participant has used the RhinoChill® device to treat three episodes of migraine, or a duration of 3 months post-study has passed, the final meeting is booked.

Meeting 3, home visit (research support team):

• Collection of device and other equipment
• Evaluation on any side effects/adverse events/CRF 4.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, 22355
    • Lund University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Meets the International Classification of Headache Disorders (2nd edition) criteria for episodic migraine, with or without aura.
• Migraine diagnosis >1 year
• Migraine attacks 2-8 times/month
• Living in Malmö-Lund area
• Reliable contraception (fertile women)

Exclusion Criteria:

• Any change of migraine prophylaxis within three months prior to study begin
• Failure of participant to adhere to protocol requirements
• Smoker or smoker in participants household
• Prior nose surgery or intranasal obstruction
• Pregnancy, breast feeding or planned pregnancy during trial period
• Oxygen dependency
• Medical history of skull base fracture or severe facial trauma
• No migraine attacks during prolonged screening phase (60 days)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Rhinochill; Treatment with nasal cavity cooling 10 minutes during three consecutive migraine attacks.	Device: Nasal cavity cooling device.; The RhinoChill® system cools by intranasal evaporation of a liquid coolant sprayed onto the surface of the nasal cavity. The RhinoChill® system is intended for use for the relief of pain and symptoms associated with acute migraine attack.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of headache	Scoring of headache on a 4-graded scale (none-mild-moderate-severe).	10 minutes after baseline (immediately after treatment) compared to baseline
Reduction of nausea	Scoring of symptoms on a 4-graded scale (none-mild-moderate-severe) regarding nausea	10 minutes after baseline (immediately after treatment) compared to baseline
Reduction of photophobia	Scoring of symptoms on a 4-graded scale (none-mild-moderate-severe) regarding photophobia	10 minutes after baseline (immediately after treatment) compared to baseline
Reduction of phonophobia	Scoring of symptoms on a 4-graded scale (none-mild-moderate-severe) regarding photophonia	10 minutes after baseline (immediately after treatment) compared to baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache response	The patient scores the headache symptoms on a 4-graded scale (none-mild-moderate-severe). Any improvement of pain is recorded.	Comparing baseline/before treatment and 1. immediately following treatment (10 minutes),2. 1 hour, 3. 2 hours and 4. 24 hours following treatment.
Relapse incidence	Frequency of headache returns	Between 2-48 hours after intervention
Sustained pain freedom, number of patients that sustain pain freedom 2-48 hours after intervention.	pain free with no use of rescue medication or relapse	2-48 hours after intervention
Impact on nausea	Scoring of symptoms none-mild-moderate-severe regarding nausea	At baseline and 1, 2, 24 hours after treatment
Impact on photophobia	Scoring of symptoms none-mild-moderate-severe regarding photophobia	At baseline and 1, 2, 24 hours after treatment
Impact on phonophobia	Scoring of symptoms none-mild-moderate-severe regarding , photophobia and phonophobia	At baseline and 1, 2, 24 hours after treatment
Comparison of headache response between RhinoChill compared to standard treatment during screening period	Comparison of average treatment effect on headache respons between standard treatment and intervention. Scoring of headache on a 10-graded scale, where higher values represents more pain	Screening phase compared to intervention phase
Average headache pain relief	Scoring of pain on a 4-graded scale, (none-mild-moderate-severe) compared to baseline.	At baseline and 10 minutes, 1, 2 and 24 hours after treatment.
Tolerance to rhinochill cooling - pain	Visual/analogue pain on a 10-graded scale, where higher values represents more pain.	10 minutes-1 hour
Tolerance to rhinochill cooling - discomfort	Visual/analogue discomfort score, on a 10-graded scale, where higher values represents more discomfort.	10 minutes-1 hour
Adverse events	Any adverse events noted during the treatment, following treatment or during follow up	through study completion, an approximated average of 3 months.

Collaborators and Investigators

• Sponsor: Lund University
• Collaborators: BrainCool
• Investigators: Study Chair: Patrik Midlöv, Professor, Department of Clinical Sciences, Malmö, Lund University, Sweden; Principal Investigator: Moa Wolff, PhD, Department of Clinical Sciences, Malmö, Lund University, Sweden

Publications and helpful links

General Publications

• Vanderpol J, Bishop B, Matharu M, Glencorse M. Therapeutic effect of intranasal evaporative cooling in patients with migraine: a pilot study. J Headache Pain. 2015 Jan 26;16:5. doi: 10.1186/1129-2377-16-5.
• Ucler S, Coskun O, Inan LE, Kanatli Y. Cold Therapy in Migraine Patients: Open-label, Non-controlled, Pilot Study. Evid Based Complement Alternat Med. 2006 Dec;3(4):489-93. doi: 10.1093/ecam/nel035. Epub 2006 Jun 15.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 3, 2021
• Primary Completion (ACTUAL): December 23, 2021
• Study Completion (ACTUAL): December 23, 2021

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (ACTUAL): December 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 21, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Migraine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: 2019-05471

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No