Clinical trial NCT04660864: Nasal Cavity Cooling for the Symptomatic Relief of Migraine Headache - a Pilot Study
Official title: Nasal Cavity Cooling for the Symptomatic Relief of Migraine Headache - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: Migraine
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: BrainCool
First posted: 2020-12-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group assignment.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Reduction of headache
timeFrame: 10 minutes after baseline (immediately after treatment) compared to baseline
measure: Reduction of nausea
timeFrame: 10 minutes after baseline (immediately after treatment) compared to baseline
measure: Reduction of photophobia
timeFrame: 10 minutes after baseline (immediately after treatment) compared to baseline
measure: Reduction of phonophobia
timeFrame: 10 minutes after baseline (immediately after treatment) compared to baseline
Secondary outcomes:
measure: Headache response
timeFrame: Comparing baseline/before treatment and 1. immediately following treatment (10 minutes),2. 1 hour, 3. 2 hours and 4. 24 hours following treatment.
measure: Relapse incidence
timeFrame: Between 2-48 hours after intervention
measure: Sustained pain freedom, number of patients that sustain pain freedom 2-48 hours after intervention.
timeFrame: 2-48 hours after intervention
measure: Impact on nausea
timeFrame: At baseline and 1, 2, 24 hours after treatment
measure: Impact on photophobia
timeFrame: At baseline and 1, 2, 24 hours after treatment
measure: Impact on phonophobia
timeFrame: At baseline and 1, 2, 24 hours after treatment
measure: Comparison of headache response between RhinoChill compared to standard treatment during screening period
timeFrame: Screening phase compared to intervention phase
measure: Average headache pain relief
timeFrame: At baseline and 10 minutes, 1, 2 and 24 hours after treatment.
measure: Tolerance to rhinochill cooling - pain
timeFrame: 10 minutes-1 hour
measure: Tolerance to rhinochill cooling - discomfort
timeFrame: 10 minutes-1 hour
measure: Adverse events
timeFrame: through study completion, an approximated average of 3 months.
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University
Study officials:
affiliation: Department of Clinical Sciences, Malmö, Lund University, Sweden
name: Patrik Midlöv, Professor
role: STUDY_CHAIR
affiliation: Department of Clinical Sciences, Malmö, Lund University, Sweden
name: Moa Wolff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.