Intranasal Cooling for Cluster Headache and Migraine (COOLHEAD)
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 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|
- • 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.
- 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.
|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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01898455
|Contact: Barbara E Bishopfirstname.lastname@example.org|
|Neurosciences department, Penrith Hospital, Cumbria Partnership NHS Foundation Trust||Not yet recruiting|
|Penrith, Cumbria, United Kingdom, CA11 8HX|
|Contact: Jitka Vanderpol, MD 01768245667 email@example.com|
|Principal Investigator: Jitka Vanderpol, MD FRCP|
|Principal Investigator:||Jitka Vanderpol, MD||Cumbria Partnership NHS Foundation Trust|