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BrainCool-Migraine Intranasal Cooling Trial

This study is currently recruiting participants.
Verified November 2017 by Cumbria Partnership NHS Foundation Trust
Sponsor:
ClinicalTrials.gov Identifier:
NCT03167060
First Posted: May 25, 2017
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
BrainCool AB
Information provided by (Responsible Party):
Cumbria Partnership NHS Foundation Trust
  Purpose
This study will be a randomised placebo controlled trial examining the effectiveness of using an intranasal evaporative cooling device (the RhinoChill intransal device) in providing relief of pain and symptoms of acute migraine.The treatment works by introducing cooling into the passageways of the nose through two small cannulas thereby cooling 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. In total, 90 patients randomised in a 1:1 fashio n will be recruited from three different NHS Trusts. 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 3 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, if indicated.

Condition Intervention
Migraine Device: Active RhinoChill Device: Control Rhinochill

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Post-market clinical study of one or more CE marked devices within intended purposes, involving a change to standard care or randomisation between groups
Masking: Single (Participant)
Masking Description:
Controls will undergo same treatment with the medical device, but it will be a sham treatment
Primary Purpose: Treatment
Official Title: Nasal Cavity Cooling for the Symptomatic Relief of Migraine Headache - A Randomized, Double Blind, Placebo Controlled Study" , the BrainCool-Migraine Study

Resource links provided by NLM:


Further study details as provided by Cumbria Partnership NHS Foundation Trust:

Primary Outcome Measures:
  • Participant is pain free at two hours following trial device treatment The patients' first treatment will be used for analysis of the superiority of the rate of patients pain free at two hours following treatment for those receiving the standard R [ Time Frame: two hours ]
    The first treatment with the RhinoChill device will be used for analysis of the superiority of the rate of participants who are pain free at two hours following treatment for those receiving the standard RhinoChill® treatment. This will be compared to those participants who are randomised to receive sham device treatment. Likert scale questionnaire will record the outcome


Secondary Outcome Measures:
  • Percentage of patients pain free immediately after treatment (10 minutes), at 1 hour, and 24 hours following treatment [ Time Frame: 10 minutes, 1 hour, 24 hours ]
    Likert scale questionnaire will record the outcome

  • Headache response [ Time Frame: 10 min, 1 hour, 2 hours, 24 hours ]
    Improvement of pain from severe/moderate to mild/none immediately following treatment (10 minutes), at 1 hour, 2 hours, and 24 hours following treatment. Likert scale questionnaire will record the outcome

  • relapse incidence [ Time Frame: 2 hours, 48 hours ]
    frequency of headache return between 2 and 48 hours after the intervention. Binary outcome questionnaire

  • Sustained pain freedom [ Time Frame: 2 hours, 48 hours ]
    pain free at 2 hours with no use of rescue medication or relapse within toal of 48 hours after treatment commenced. Likert scale questionnaire will record the outcome

  • Total migraine freedom [ Time Frame: 2 hours ]
    absence of pain, nausea, photophobia and phonophobia at 2 hours. Likert scale questionnaire will record the outcome


Estimated Enrollment: 90
Actual Study Start Date: May 8, 2017
Estimated Study Completion Date: November 30, 2018
Estimated Primary Completion Date: September 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Rhinochill
Intranasal cooling device , using nasal cannula
Device: Active RhinoChill

Participants will be provided with a RhinoChill® device (Active) and an Intranasal Migraine catheter. Once they have the RhinoChill® device, they are asked to treat the next two of your migraines with the device. This requires a maximum of 10 minute intra-nasal treatment as soon as possible after the start of your migraine.

The participation in the trial will last until 3 migraine headaches have been treated with the RhinoChill® device.

Sham Comparator: Control Rhinochill
Intranasal cooling device , using nasal cannula (difference with active device not disclosed to maintain blindness)
Device: Control Rhinochill

Participants will be provided with a RhinoChill® device (Sham) and an Intranasal Migraine catheter. Once they have the RhinoChill® device, they are asked to treat the next two of your migraines with the device. This requires a maximum of 10 minute intra-nasal treatment as soon as possible after the start of your migraine.

The participation in the trial will last until 3 migraine headaches have been treated with the RhinoChill® device.


  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • 18 Years old 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 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 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
  Contacts and Locations
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): NCT03167060


Contacts
Contact: Leon Jonker, PhD 07717225725 leon.jonker@cumbria.nhs.uk

Locations
United Kingdom
Neurosciences department, Penrith Hospital, Cumbria Partnership NHS Foundation Trust Recruiting
Penrith, Cumbria, United Kingdom, CA11 8HX
Contact: Jitka Vanderpol, MD    01768245667    jitka.vanderpol@cumbria.nhs.uk   
Principal Investigator: Jitka Vanderpol, MD FRCP         
South tees Hospital Recruiting
Middlesbrough, United Kingdom
Contact: Adrienn Petreczky, MD         
The Newcastle upon Tyne Hospitals Recruiting
Newcastle upon Tyne, United Kingdom
Contact: Paul Dorman, MD         
City Hospital, Sunderland, UK Recruiting
Sunderland, United Kingdom
Contact: Gina Kennedy, MD         
Sponsors and Collaborators
Cumbria Partnership NHS Foundation Trust
BrainCool AB
Investigators
Principal Investigator: Jitka Vanderpol, MD Cumbria Partnership NHS Foundation Trust
  More Information

Publications:
Responsible Party: Cumbria Partnership NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03167060     History of Changes
Other Study ID Numbers: CP1628
First Submitted: May 19, 2017
First Posted: May 25, 2017
Last Update Posted: November 8, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases