Intranasal Cooling for Cluster Headache and Migraine (COOLHEAD)

December 3, 2014 updated by: Cumbria Partnership NHS Foundation Trust

IntraNasal Evaporative Cooling for the Symptomatic Relief of Migraine and Cluster Headache

This study will be looking at the clinical efficacy of using a intranasal evaporative cooling device in providing relief of the symptoms of migraine and cluster headache. It will involve using a nasal catheter to spray a liquid coolant into the nasal cavity where it evaporates and removes heat from the tissue, thereby cooling the tissue and the blood vessels which supply blood to the brain. This cooling effect will cause the blood vessels to constrict and it is thought that this may provide symptomatic relief in both these forms of headache. 10 migraine patients and 5 cluster headache patients will be enrolled in the study and will receive 10 treatments each, for a maximum of 20 minutes at a time. They will be monitored during the treatment and for two hours afterwards to assess headache severity and side effects. There will be a further follow up 2 months after the last treatment to assess for longer term side effects from the treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Cumbria
      • Penrith, Cumbria, United Kingdom, CA11 8HX
        • Neurosciences department, Penrith Hospital, Cumbria Partnership NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • >18 Years old.
  • Meets criteria for NICE guidelines diagnosis of cluster headache or chronic migraine
  • Has not responded satisfactorily to migraine prophylaxis or standard analgesia
  • Capable of giving informed consent

Exclusion Criteria:

  • < 18 years of age
  • Subject has history of other severe co-morbid illness which would prevent full participation in the study
  • Inability to insert the nasal cannulae
  • Known temperature sensitive disorder such as reynauds, cryoglobulinaemia
  • Known oxygen dependency to maintain SaO2 >95%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intranasal Cooling
RhinoChill Intranasal cooling, administered for 20 minutes. 10 treatment sessions per participant.
Device: RhinoChill intranasal cooling
The RhinoChill device will be used to locally cool the posterior nasopharynx, surrounding tissues and vasculature using a variable cooling flow rate based on patient comfort and tolerance, for a maximum of 20 minutes. Local anaesthetic spray will be administered to patients if the nasal catheters or cooling is poorly tolerated.
Other Names:
  • RhinoChill
  • Intranasal cooling
  • transnasal cooling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• Reduction of pain score and overall symptoms from baseline in Migraine/cluster headache sufferers
Time Frame: 20 minutes
When a participant presents with headache, baseline assessments will be performed for pain, nausea and other recognised symptoms of migraine/cluster headache. The Rhinochill device will be used to provide transnasal cooling for a period of 20 minutes then reassessment of pain and other symptoms will be undertaken.
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerance to Rhinochill cooling during maximum 20 minutes treatment
Time Frame: 20 minutes
Visual/analogue pain score and visual/analogue discomfort score
20 minutes
Adverse events noted throughout treatment phase and during follow up
Time Frame: 1 year
• Any adverse events noted during the treatment or following treatment and during routine follow up will be recorded and analysed.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cumbria Partnership NHS Foundation Trust

Collaborators

BeneChill, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

July 10, 2013

First Submitted That Met QC Criteria

July 10, 2013

First Posted (ESTIMATE)

July 12, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 3, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPFT001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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