Intranasal Cooling for Cluster Headache and Migraine

NCT01898455 | Completed

• 1 other identifier: CPFT001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Cluster Headache

Keywords

Migraine; Cluster headache; headache

Outcome Measures

Primary Outcomes (1)

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

  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.

  20 minutes

Secondary Outcomes (2)

• Tolerance to Rhinochill cooling during maximum 20 minutes treatment

  20 minutes

• Adverse events noted throughout treatment phase and during follow up

  1 year

Study Arms (1)

Intranasal Cooling

EXPERIMENTAL

RhinoChill Intranasal cooling, administered for 20 minutes. 10 treatment sessions per participant.

Device: RhinoChill intranasal cooling

Interventions

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.

Also known as: RhinoChill, Intranasal cooling, transnasal cooling

Intranasal Cooling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• \< 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%

Sponsors & Collaborators

• Cumbria Partnership NHS Foundation Trust: lead
• BeneChill, Inc: collaborator

Study Sites (1)

Neurosciences department, Penrith Hospital, Cumbria Partnership NHS Foundation Trust

Penrith, Cumbria, CA11 8HX, United Kingdom

Location

Related Publications (1)

• Vanderpol J, Bishop B, Matharu M, Glencorse M. Therapeutic effect of intranasal evaporative cooling in patients with migraine: a pilot study. J Headache Pain. 2015 Jan 26;16:5. doi: 10.1186/1129-2377-16-5.

  PMID: 25623151 DERIVED

MeSH Terms

Conditions

Migraine Disorders; Cluster Headache; Headache

Condition Hierarchy (Ancestors)

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

Study Officials

• Jitka Vanderpol, MD

  Cumbria Partnership NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2013
• First Posted: July 12, 2013
• Study Start: August 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 4, 2014

Record last verified: 2014-12

Locations

GB (1)