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OpenTrials
Completed

NCT Number: NCT01898455

Intranasal Cooling for Cluster Headache and Migraine

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Cluster Headache Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Trigeminal Autonomic Cephalalgias

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurosciences department, Penrith Hospital, Cumbria Partnership NHS Foundation Trust

Penrith, Cumbria, CA11 8HX, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

RhinoChill intranasal cooling

Device

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

Primary outcomes

  1. • 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.

Secondary outcomes

  1. Tolerance to Rhinochill cooling during maximum 20 minutes treatment

    Time frame: 20 minutes

    Visual/analogue pain score and visual/analogue discomfort score

  2. 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.

Sponsors and collaborators

Lead sponsor

Cumbria Partnership NHS Foundation Trust

Other

Collaborators

  • BeneChill, Inc

Registry information

Official study title

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

Acronym: COOLHEAD

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 12, 2013
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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