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Intranasal Cooling for Cluster Headache and Migraine

NCT ID: NCT01898455

Last Updated: 2014-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Migraine Cluster Headache

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intranasal Cooling

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

Group Type EXPERIMENTAL

RhinoChill intranasal cooling

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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RhinoChill Intranasal cooling transnasal cooling

Eligibility Criteria

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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%
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BeneChill, Inc

INDUSTRY

Sponsor Role collaborator

Cumbria Partnership NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jitka Vanderpol, MD

Role: PRINCIPAL_INVESTIGATOR

Cumbria Partnership NHS Foundation Trust

Locations

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Neurosciences department, Penrith Hospital, Cumbria Partnership NHS Foundation Trust

Penrith, Cumbria, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 25623151 (View on PubMed)

Other Identifiers

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CPFT001

Identifier Type: -

Identifier Source: org_study_id