MigraineCOOLHEADNCT01898455
Intranasal Cooling for Cluster Headache and Migraine
A study testing RhinoChill intranasal cooling in people with Migraine and Cluster Headache, run by Cumbria Partnership NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, Cluster Headache
- What is being tested?
- RhinoChill intranasal cooling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- < 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%
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Neurosciences department, Penrith Hospital, Cumbria Partnership NHS Foundation Trust
Penrith, Cumbria, CA11 8HX
About this study
Official title: IntraNasal Evaporative Cooling for the Symptomatic Relief of Migraine and Cluster Headache
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
- Being tested
- RhinoChill intranasal cooling
- Keywords
- Migraine, Cluster headache, headache
- Medical subject headings
- Migraine Disorders, Cluster Headache, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RhinoChill intranasal coolingDevice
Also called RhinoChill, Intranasal cooling, transnasal 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.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Cooling | Experimental | RhinoChill Intranasal cooling, administered for 20 minutes. 10 treatment sessions per participant. Receives: Device: RhinoChill intranasal cooling |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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.
Measured: 20 minutes
Secondary outcomes (2)
Tolerance to Rhinochill cooling during maximum 20 minutes treatment
Visual/analogue pain score and visual/analogue discomfort score
Measured: 20 minutes
Adverse events noted throughout treatment phase and during follow up
- Any adverse events noted during the treatment or following treatment and during routine follow up will be recorded and analysed.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumbria Partnership NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- BeneChill, Inc
- Responsible party
- Sponsor
- Investigators
- Jitka Vanderpol, MD, Principal investigator, Cumbria Partnership NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898455
- Sponsor's protocol ID
- CPFT001
- Acronym
- COOLHEAD
- Status last verified
- Dec 2014
- First submitted
- 10 Jul 2013
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25623151
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IntraNasal Evaporative Cooling for the Symptomatic Relief of Migraine and Cluster Headache
- ClinicalTrials.gov ID
- NCT01898455
- Acronym / sponsor ID
- COOLHEAD / CPFT001
- Conditions
- Migraine, Cluster Headache
- Keywords
- Migraine, Cluster headache, headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Cumbria Partnership NHS Foundation TrustUniversity, hospital or other
- Collaborators
- BeneChill, Inc
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 12 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intranasal Cooling | Experimental | Device: RhinoChill intranasal coolingRhinoChill Intranasal cooling, administered for 20 minutes. 10 treatment sessions per participant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >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
Key exclusion criteria (5 listed)
- < 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RhinoChill intranasal coolingAlso: RhinoChill, Intranasal cooling, transnasal coolingThe 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. | Device | Intranasal Cooling |
Primary outcome
• 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.
2 secondary outcomes
Tolerance to Rhinochill cooling during maximum 20 minutes treatment
Time frame: 20 minutes
Adverse events noted throughout treatment phase and during follow up
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
- Derived from this study: PubMed 25623151Vanderpol 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.
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jitka Vanderpol, MD principal investigator
Cumbria Partnership NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RhinoChill intranasal cooling in people with Migraine and Cluster Headache, run by Cumbria Partnership NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Reduction of pain score and overall symptoms from baseline in Migraine/cluster headache sufferers (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01898455, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2014.