COOLHEAD: Intranasal Cooling for Cluster Headache and Migraine

Sponsor

Cumbria Partnership NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT01898455

Collaborator

BeneChill, Inc (Industry)

Enrollment

Location

Arm

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Migraine Cluster Headache	Device: RhinoChill intranasal cooling	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

• Reduction of pain score and overall symptoms from baseline in Migraine/cluster headache sufferers [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 Outcome Measures

Tolerance to Rhinochill cooling during maximum 20 minutes treatment [20 minutes]
Visual/analogue pain score and visual/analogue discomfort score
Adverse events noted throughout treatment phase and during follow up [1 year]
• Any adverse events noted during the treatment or following treatment and during routine follow up will be recorded and analysed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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%