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

NCT04660864 | Completed

• 1 other identifier: 2019-05471
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

Migraine

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (11)

• Headache response

  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

  Between 2-48 hours after intervention

• Sustained pain freedom, number of patients that sustain pain freedom 2-48 hours after intervention.

  2-48 hours after intervention

• Impact on nausea

  At baseline and 1, 2, 24 hours after treatment

• Impact on photophobia

  At baseline and 1, 2, 24 hours after treatment

Study Arms (1)

Rhinochill

EXPERIMENTAL

Treatment with nasal cavity cooling 10 minutes during three consecutive migraine attacks.

Device: Nasal cavity cooling device.

Interventions

Nasal cavity cooling device. 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.

Rhinochill

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Lund University: lead
• BrainCool: collaborator

Study Sites (1)

Lund University

Lund, 22355, Sweden

Location

Related Publications (2)

• 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.

  PMID: 25623151 BACKGROUND

• 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.

  PMID: 17173113 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Patrik Midlöv, Professor

  Department of Clinical Sciences, Malmö, Lund University, Sweden

  STUDY CHAIR

• Moa Wolff, PhD

  Department of Clinical Sciences, Malmö, Lund University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group assignment.

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: December 9, 2020
• Study Start: March 3, 2021
• Primary Completion: December 23, 2021
• Study Completion: December 23, 2021
• Last Updated: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)