Intranasal Cooling for Cluster Headache and Migraine (COOLHEAD)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by Cumbria Partnership NHS Foundation Trust
Sponsor:
Collaborator:
BeneChill, Inc
Information provided by (Responsible Party):
Cumbria Partnership NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01898455
First received: July 10, 2013
Last updated: NA
Last verified: July 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Migraine
Cluster Headache
Device: RhinoChill intranasal cooling

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: IntraNasal Evaporative Cooling for the Symptomatic Relief of Migraine and Cluster Headache

Resource links provided by NLM:


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

Primary Outcome Measures:
  • • Reduction of pain score and overall symptoms from baseline in Migraine/cluster headache sufferers [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Tolerance to Rhinochill cooling during maximum 20 minutes treatment [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    Visual/analogue pain score and visual/analogue discomfort score

  • Adverse events noted throughout treatment phase and during follow up [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    • Any adverse events noted during the treatment or following treatment and during routine follow up will be recorded and analysed.


Estimated Enrollment: 15
Study Start Date: August 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01898455

Contacts
Contact: Barbara E Bishop 01228602170 barbara.bishop@cumbria.nhs.uk

Locations
United Kingdom
Neurosciences department, Penrith Hospital, Cumbria Partnership NHS Foundation Trust Not yet recruiting
Penrith, Cumbria, United Kingdom, CA11 8HX
Contact: Jitka Vanderpol, MD    01768245667    jitka.vanderpol@cumbria.nhs.uk   
Principal Investigator: Jitka Vanderpol, MD FRCP         
Sponsors and Collaborators
Cumbria Partnership NHS Foundation Trust
BeneChill, Inc
Investigators
Principal Investigator: Jitka Vanderpol, MD Cumbria Partnership NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Cumbria Partnership NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01898455     History of Changes
Other Study ID Numbers: CPFT001
Study First Received: July 10, 2013
Last Updated: July 10, 2013
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee
United Kingdom: Department of Health

Keywords provided by Cumbria Partnership NHS Foundation Trust:
Migraine
Cluster headache
headache

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

ClinicalTrials.gov processed this record on September 22, 2014