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Intranasal Cooling for Symptomatic Relief of Migraine (COOLHEAD2)

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ClinicalTrials.gov Identifier: NCT02375789
Recruitment Status : Terminated (Due to insolvency of sponsor)
First Posted : March 3, 2015
Last Update Posted : February 3, 2017
Sponsor:
Collaborator:
BeneChill, Inc
Information provided by (Responsible Party):
Cumbria Partnership NHS Foundation Trust

Brief Summary:
This study will be a randomised placebo controlled trial examining the effectiveness of using an intranasal cooling device (the RhinoChill) in providing relief of pain and symptoms of acute migraine. It will involve using two nasal catheters to cool the nasal cavity which provides localised cooling of the local nasal tissue and the blood vessels which supply blood to the brain. This cooling effect will cause the blood vessels to constrict as well as stimulating special cold receptors that are thought to be involved in the relief of migraine, thereby providing both pain and associated symptomatic relief. Ninety patients will be randomised in a 1:1 fashion, clustered to three different recruitment sites. The patients will have a 30 day period of data collection for their current migraine frequency, treatment and response to medication (with a minimum of 2 migraine attacks recorded) before starting the treatment phase with the RhinoChill Device. Treatment will be for 2 migraine attacks. Only a single treatment is allowed for the first attack, but on the second attack the patient may deliver 2 treatments with a gap of at least 2 hours between treatments.

Condition or disease Intervention/treatment Phase
Migraine Headache Device: Active RhinoChill Device: Placebo RhinoChill Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intranasal Evaporative COOLing for the Symptomatic Relief of Migraine HEADache - A Randomized, Double Blind, Placebo Controlled Study"
Actual Study Start Date : October 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Active Comparator: Active RhinoChill

Following the initial 30 days (and minimum of 2 separate migraine attacks) of data collection the patient will be trained in the use and self administration of the RhinoChill device.

At the onset of an acute migraine, the patient will insert the RhinoChill Migraine Intranasal catheters and commence a 10 minute treatment on the Low Flow setting of the device.

During this time the patient will complete the basic data record sheets to document current symptoms and changes in severity throughout the period of treatment and then at specific time points thereafter.

The patient remains in the trial until two separate migraines have been treated.

Device: Active RhinoChill

The device is intended for use for the reduction of temperature via the nasal cavity.

The RhinoChill® System is a British Standards Institution Kite-Marked device that is currently commercially available in Europe. The RhinoChill® device is intended for temperature reduction in patients via the nasal cavity.

Other Name: RhinoChill

Placebo Comparator: Placebo RhinoChill

The same procedure will be followed for the placebo comparator as in the active comparator. The RhinoChill device looks identical and functions in a very similar way to the active device however through some minor design changes the device has been altered to provide a sufficient placebo treatment.

At the onset of an acute migraine headache the patient will insert the RhinoChill Migraine Intranasal catheters and the 10 minute treatment is commenced on Low Flow.

During this time the patient will complete the basic data record sheets to document current symptoms and changes in severity throughout the period of treatment and then at specific time points thereafter.

The patient remains in the trial until two separate migraines have been treated.

Device: Placebo RhinoChill
The placebo RhinoChill device looks and functions in an identical way to the active RhinoChill. All components are used, however through some minor changes in the design of the device it now provides a sufficient placebo treatment to the patient.
Other Name: RhinoChill




Primary Outcome Measures :
  1. Pain free at two hours following treatment [ Time Frame: Two hours following treatment ]
    Percentage of patients who are pain free two hours following treatment


Secondary Outcome Measures :
  1. Percentage of patients pain free [ Time Frame: 10 mins, 1 hour, 2 hours, 24 hours ]
    Percentage of patients scoring a pain intensity score of None

  2. Headache response [ Time Frame: 10 mins, 1 hour, 24 hours ]
    Headache response - Improvement of pain from Severe/Moderate to mild/none immediately following treatment and at one hour and 24 hours following treatment.

  3. Pain response [ Time Frame: 10 mins, 1 hour, 2 hours, 24 hours ]
    Change in pain score (Visual Analogue Score of 0-10) immediately following treatment and at one hour, 2 hours and 24 hours following treatment.

  4. Relapse Incidence [ Time Frame: Between 2 and 48 hours after the intervention ]
    Relapse Incidence - Frequency of headache return between 2 and 48 hours after the intervention

  5. Sustained Pain Freedom [ Time Frame: Between 1 and 24 hours after the intervention ]
    Pain free at 2 hours with no use of rescue medication or relapse within the subsequent 46 hours

  6. Total Migraine Freedom [ Time Frame: Between 1 and 24 hours after the intervention ]
    Absence of pain, nausea, photophobia and phonophobia at 2 hours

  7. Change in Headache Intensity during treatment. [ Time Frame: 5 mins and 10 mins ]
    Change in Headache Intensity during treatment.

  8. Change in Headache Intensity 2 hours following treatment [ Time Frame: 2 hours following treatment. ]
    Change in Headache Intensity 2 hours following treatment

  9. Time to meaningful relief [ Time Frame: Between 10 mins and 24 hours after the intervention ]
    Time to meaningful relief. Time to meaningful relief Time to freedom from pain

  10. Time to freedom from pain [ Time Frame: Between 10 mins and 24 hours after the intervention ]
    Time to freedom from pain Time to meaningful relief Time to freedom from pain

  11. Percentage of patients taking rescue medication at 2 hours after treatment [ Time Frame: 2 hours after treatment ]
    Percentage of patients taking rescue medication at 2 hours after treatment

  12. Global Impression of Change [ Time Frame: to be completed at the end of trial period, an average of 8-10 weeks ]
    Global Impression of Change

  13. Global impact on disability. [ Time Frame: to be completed at the end of trial period, an average of 12 weeks ]
    Global impact on disability. Global impact on disability and Quality of life

  14. Global impact on quality of life [ Time Frame: to be completed at the end of trial period, an average of 12 weeks ]
    Global impact on quality of life Global impact on disability and Quality of life

  15. Impact on migraine associated symptoms [ Time Frame: To be measured at 10 mins, 1 hour, 2 hours, 24 hours ]

    Impact on migraine associated symptoms:

    Nausea Photophobia Phonophobia


  16. Migraine pain scores, pre intervention data collection period versus treatment with the intervention. [ Time Frame: to be completed at the end of trial period, an average of 12 weeks ]
    Migraine pain score, pre intervention data collection period versus treatment with the intervention.

  17. Comparison of symptoms scores between pre intervention data collection period and treatment with the intervention. [ Time Frame: to be completed at the end of trial period, an average of 12 weeks ]

    Comparison of symptoms scores between pre intervention data collection period and treatment with the intervention.

    • Headache severity Severe/moderate - mild/none
    • VAS score (0-10 pain scale & Symptom severity)

  18. Adverse events [ Time Frame: From day one of the intervention period until 48 hours post 2nd trial treatment ]
    Adverse events noted throughout the treatment phase and during follow up



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 Years or over and ≤70 years of age.
  • Migraine diagnosis of at least 1 year.
  • Migraine attacks between 1 and 15 per month.
  • Onset of first migraine < 50 years of age.
  • Migraine prophylaxis medication unchanged for 3 months prior to enrollment
  • Meets International Classification for Headache Disorders (2nd Edition) criteria for diagnosis of Episodic Migraine with or without aura
  • Able to attend and understand a short training session on the practical use of the RhinoChill device and agrees to only use the device as instructed and as laid out in the official instructions for use.

Exclusion Criteria:

  • < 18 and >70 years of age
  • Known oxygen dependency to maintain SaO2 >95%
  • Diagnosed Hypertensive and currently uncontrolled with Systolic BP > 140mmHg and Diastolic BP > 90mmHg on baseline assessment.
  • Marked nasal septal deviation, recurrent epistaxis or chronic Rhino-Sinusitis
  • Intranasal obstruction preventing full insertion of nasal catheter
  • Known acute base of skull fracture or facial trauma
  • Concurrent sinus/intranasal surgery
  • Diagnosed with thromobocytopenia.
  • Previous Stroke or Myocardial Infarction
  • Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity
  • Previously enrolled into the COOLHEAD 1 trial
  • No recorded migraine following initial 30 day data collection period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375789


Locations
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United Kingdom
Neurosciences department, Penrith Hospital, Cumbria Partnership NHS Foundation Trust
Penrith, Cumbria, United Kingdom, CA11 8HX
CITY HOSPITALS SUNDERLAND NHS FOUNDATION TRUST, 11 Norfolk Street, Sunderland SR1 1EA
Sunderland, Tyne and Wear, United Kingdom, SR4 7TP
The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust
Middlesborough, United Kingdom, TS4 3BW
Sponsors and Collaborators
Cumbria Partnership NHS Foundation Trust
BeneChill, Inc
Investigators
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Principal Investigator: Jitka Vanderpol, MD FRCP Cumbria Partnership NHS Foundation Trust

Publications:

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Responsible Party: Cumbria Partnership NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02375789     History of Changes
Other Study ID Numbers: 3414
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017

Keywords provided by Cumbria Partnership NHS Foundation Trust:
Migraine Headache
Cooling
Intranasal
Rhinochill

Additional relevant MeSH terms:
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Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms