- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02375789
Intranasal Cooling for Symptomatic Relief of Migraine (COOLHEAD2)
Intranasal Evaporative COOLing for the Symptomatic Relief of Migraine HEADache - A Randomized, Double Blind, Placebo Controlled Study"
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a multi centre, double blinded, randomized, prospective, parallel placebo controlled trial for demonstrating the effectiveness of the RhinoChill System for the symptomatic relief of migraine headache.
The specific study design consists of:
- Participant identification from neurology clinic records and gaining initial consent to transfer contact details to the trial team.
- Telephone contact or direct clinic contact with potential participants to describe the COOLHEAD 2 trial and to seek expressions of interest.
- Initial meetings with potential participants and discussion of trial, provision of patient information leaflets. Informed Consent taking.
- Initial 30 day prospective data collection period (minimum of 2 migraine attacks, longer period if needed)
- Randomisation to either placebo or active RhinoChill
- Device Delivery and training session for the use of the RhinoChill device, self administration, and record keeping.
- Treatment period for the treatment of 2 separate migraines with the RhinoChill.
During an initial screening visit or phonecall, the trial will be discussed with the potential participant and the inclusion/exclusion checklist will be completed.
If the patient meets all inclusion criteria and none of the exclusion criteria, they will be asked for permission to pass on contact details to a member of the trial team for further contact.
Arrangements will then be made for a meeting with the patient either at the clinic or in their own home to further discuss the trial and to consider enrolling into the study. At this time, they will be provided with a patient information sheet and will be shown the RhinoChill device. The patient will be given the opportunity to fully consider all aspects of participation in this trial and to discuss it with family members if they so wish before being being consented into the trial by a member of the study team.
At the time of consent, the researcher will also collect data for the baseline CRF and provide initial instruction on completion of the first stage data collection forms (further described below)
At the baseline visit, the patient will first be given the opportunity to ask any questions they may have about the research. A member of the research team will take informed consent and gain signatures on the consent form. Baseline data will then be collected, including history of migraine headache, frequency, severity of symptoms, medication and therapies currently ongoing or taken in the past. Base line vital signs will also be recorded at this time. Once completed, a short training session on completion of the prospective data collection forms for phase 1 of the trial will given and use of the supplied blood pressure machine and pulse oxymeter machine. Once the baseline visit has been completed the patient will begin a 30 day period of self data collection based on their migraine experience during that time frame and using data capture forms provided by the research nurse (a minimum of 2 migraine attacks are required, therefore if 2 have not occurred during the 30 days, further time will be given to allow the second migraine to occur).
If a patient has not had a single migraine in the first 30 days, then they will not be able to continue to the treatment phase as they have not met the inclusion criteria of at least 1 migraine per month. Following the conclusion to this initial period, the treatment phase will then begin.
After the end of the prospective data collection period, the patient will be randomised to either active treatment or placebo treatment. Randomisation will be provided by sealed envelopes held by E&E CRO services (Vienna) who are also acting as independent monitors of the trial. Randomisation was performed via the online system www.sealedenvelope.com.
Training will be undertaken to ensure that the patient is fully competent and safe in the use of the RhinoChill intranasal cooling device.
The patient will be instructed on:
- Preparation of the device
- Insertion of the nasal catheter
- Selecting correct flow rate
- Positioning during treatment
- Cleaning and storage of the nasal catheters
- Trial documentation
- 24 hour contact numbers for additional supplies, troubleshooting and practical support.
The patient will also be left with a reference booklet for issues around the trial and the practical use of the RhinoChill device.
At the onset of migraine headache (or as soon as possible thereafter), the patient will start to complete the 'Treatment' CRF.
Each step of the treatment procedure is to be completed in order and as described to the patient. Patients are instructed that there is no scope for any alteration in the treatment order or requirements of the trial unless a safety issue becomes evident. If a patient does deviate from the standard procedures as outlined below, they are required to contact the 24 hour COOLHEAD 2 mobile phone to report the incident so that it can be reviewed and logged as a protocol deviation and reviewed by the site/principal investigator at the earliest opportunity. The RhinoChill device is then prepared for use and treatment can be administered.
The RhinoChill Migraine Intranasal catheters are then inserted and the 10 minute treatment is commenced on Low Flow. following these steps for each individual treatment:
It is recognised that participants in this study will already be taking medication for their migraine headache. Normal prophylaxis will be allowed as part of the trial and will be recorded in the initial screening interview. No change in prophylaxis is allowed within three months of the start of the trial or while the patient is participating in the trial.
However, acute treatments such as triptans are allowed to be taken but must be withheld until at least two hours following completion of treatment with the RhinoChill to allow assessment of the intervention. Any rescue medication taken after this point will be recorded in the associated trial documentation. A full medication history along with other therapies (including alternative therapies) will also be recorded.
No new treatment or therapy will start while the participant is enrolled in this trial.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Middlesborough, United Kingdom, TS4 3BW
- The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust
-
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Cumbria
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Penrith, Cumbria, United Kingdom, CA11 8HX
- Neurosciences department, Penrith Hospital, Cumbria Partnership NHS Foundation Trust
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Tyne and Wear
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Sunderland, Tyne and Wear, United Kingdom, SR4 7TP
- CITY HOSPITALS SUNDERLAND NHS FOUNDATION TRUST, 11 Norfolk Street, Sunderland SR1 1EA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 Years or over and ≤70 years of age.
- Migraine diagnosis of at least 1 year.
- Migraine attacks between 1 and 15 per month.
- Onset of first migraine < 50 years of age.
- Migraine prophylaxis medication unchanged for 3 months prior to enrollment
- Meets International Classification for Headache Disorders (2nd Edition) criteria for diagnosis of Episodic Migraine with or without aura
- Able to attend and understand a short training session on the practical use of the RhinoChill device and agrees to only use the device as instructed and as laid out in the official instructions for use.
Exclusion Criteria:
- < 18 and >70 years of age
- Known oxygen dependency to maintain SaO2 >95%
- Diagnosed Hypertensive and currently uncontrolled with Systolic BP > 140mmHg and Diastolic BP > 90mmHg on baseline assessment.
- Marked nasal septal deviation, recurrent epistaxis or chronic Rhino-Sinusitis
- Intranasal obstruction preventing full insertion of nasal catheter
- Known acute base of skull fracture or facial trauma
- Concurrent sinus/intranasal surgery
- Diagnosed with thromobocytopenia.
- Previous Stroke or Myocardial Infarction
- Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity
- Previously enrolled into the COOLHEAD 1 trial
- No recorded migraine following initial 30 day data collection period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active RhinoChill
Following the initial 30 days (and minimum of 2 separate migraine attacks) of data collection the patient will be trained in the use and self administration of the RhinoChill device. At the onset of an acute migraine, the patient will insert the RhinoChill Migraine Intranasal catheters and commence a 10 minute treatment on the Low Flow setting of the device. During this time the patient will complete the basic data record sheets to document current symptoms and changes in severity throughout the period of treatment and then at specific time points thereafter. The patient remains in the trial until two separate migraines have been treated. |
The device is intended for use for the reduction of temperature via the nasal cavity. The RhinoChill® System is a British Standards Institution Kite-Marked device that is currently commercially available in Europe. The RhinoChill® device is intended for temperature reduction in patients via the nasal cavity.
Other Names:
|
Placebo Comparator: Placebo RhinoChill
The same procedure will be followed for the placebo comparator as in the active comparator. The RhinoChill device looks identical and functions in a very similar way to the active device however through some minor design changes the device has been altered to provide a sufficient placebo treatment. At the onset of an acute migraine headache the patient will insert the RhinoChill Migraine Intranasal catheters and the 10 minute treatment is commenced on Low Flow. During this time the patient will complete the basic data record sheets to document current symptoms and changes in severity throughout the period of treatment and then at specific time points thereafter. The patient remains in the trial until two separate migraines have been treated. |
The placebo RhinoChill device looks and functions in an identical way to the active RhinoChill.
All components are used, however through some minor changes in the design of the device it now provides a sufficient placebo treatment to the patient.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain free at two hours following treatment
Time Frame: Two hours following treatment
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Percentage of patients who are pain free two hours following treatment
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Two hours following treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients pain free
Time Frame: 10 mins, 1 hour, 2 hours, 24 hours
|
Percentage of patients scoring a pain intensity score of None
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10 mins, 1 hour, 2 hours, 24 hours
|
Headache response
Time Frame: 10 mins, 1 hour, 24 hours
|
Headache response - Improvement of pain from Severe/Moderate to mild/none immediately following treatment and at one hour and 24 hours following treatment.
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10 mins, 1 hour, 24 hours
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Pain response
Time Frame: 10 mins, 1 hour, 2 hours, 24 hours
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Change in pain score (Visual Analogue Score of 0-10) immediately following treatment and at one hour, 2 hours and 24 hours following treatment.
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10 mins, 1 hour, 2 hours, 24 hours
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Relapse Incidence
Time Frame: Between 2 and 48 hours after the intervention
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Relapse Incidence - Frequency of headache return between 2 and 48 hours after the intervention
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Between 2 and 48 hours after the intervention
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Sustained Pain Freedom
Time Frame: Between 1 and 24 hours after the intervention
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Pain free at 2 hours with no use of rescue medication or relapse within the subsequent 46 hours
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Between 1 and 24 hours after the intervention
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Total Migraine Freedom
Time Frame: Between 1 and 24 hours after the intervention
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Absence of pain, nausea, photophobia and phonophobia at 2 hours
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Between 1 and 24 hours after the intervention
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Change in Headache Intensity during treatment.
Time Frame: 5 mins and 10 mins
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Change in Headache Intensity during treatment.
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5 mins and 10 mins
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Change in Headache Intensity 2 hours following treatment
Time Frame: 2 hours following treatment.
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Change in Headache Intensity 2 hours following treatment
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2 hours following treatment.
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Time to meaningful relief
Time Frame: Between 10 mins and 24 hours after the intervention
|
Time to meaningful relief.
Time to meaningful relief Time to freedom from pain
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Between 10 mins and 24 hours after the intervention
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Time to freedom from pain
Time Frame: Between 10 mins and 24 hours after the intervention
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Time to freedom from pain Time to meaningful relief Time to freedom from pain
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Between 10 mins and 24 hours after the intervention
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Percentage of patients taking rescue medication at 2 hours after treatment
Time Frame: 2 hours after treatment
|
Percentage of patients taking rescue medication at 2 hours after treatment
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2 hours after treatment
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Global Impression of Change
Time Frame: to be completed at the end of trial period, an average of 8-10 weeks
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Global Impression of Change
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to be completed at the end of trial period, an average of 8-10 weeks
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Global impact on disability.
Time Frame: to be completed at the end of trial period, an average of 12 weeks
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Global impact on disability.
Global impact on disability and Quality of life
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to be completed at the end of trial period, an average of 12 weeks
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Global impact on quality of life
Time Frame: to be completed at the end of trial period, an average of 12 weeks
|
Global impact on quality of life Global impact on disability and Quality of life
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to be completed at the end of trial period, an average of 12 weeks
|
Impact on migraine associated symptoms
Time Frame: To be measured at 10 mins, 1 hour, 2 hours, 24 hours
|
Impact on migraine associated symptoms: Nausea Photophobia Phonophobia |
To be measured at 10 mins, 1 hour, 2 hours, 24 hours
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Migraine pain scores, pre intervention data collection period versus treatment with the intervention.
Time Frame: to be completed at the end of trial period, an average of 12 weeks
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Migraine pain score, pre intervention data collection period versus treatment with the intervention.
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to be completed at the end of trial period, an average of 12 weeks
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Comparison of symptoms scores between pre intervention data collection period and treatment with the intervention.
Time Frame: to be completed at the end of trial period, an average of 12 weeks
|
Comparison of symptoms scores between pre intervention data collection period and treatment with the intervention.
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to be completed at the end of trial period, an average of 12 weeks
|
Adverse events
Time Frame: From day one of the intervention period until 48 hours post 2nd trial treatment
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Adverse events noted throughout the treatment phase and during follow up
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From day one of the intervention period until 48 hours post 2nd trial treatment
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jitka Vanderpol, MD FRCP, Cumbria Partnership NHS Foundation Trust
Publications and helpful links
General Publications
- Castren M, Nordberg P, Svensson L, Taccone F, Vincent JL, Desruelles D, Eichwede F, Mols P, Schwab T, Vergnion M, Storm C, Pesenti A, Pachl J, Guerisse F, Elste T, Roessler M, Fritz H, Durnez P, Busch HJ, Inderbitzen B, Barbut D. Intra-arrest transnasal evaporative cooling: a randomized, prehospital, multicenter study (PRINCE: Pre-ROSC IntraNasal Cooling Effectiveness). Circulation. 2010 Aug 17;122(7):729-36. doi: 10.1161/CIRCULATIONAHA.109.931691. Epub 2010 Aug 2.
- Tfelt-Hansen P, Pascual J, Ramadan N, Dahlof C, D'Amico D, Diener HC, Hansen JM, Lanteri-Minet M, Loder E, McCrory D, Plancade S, Schwedt T; International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of drugs in migraine: third edition. A guide for investigators. Cephalalgia. 2012 Jan;32(1):6-38. doi: 10.1177/0333102411417901. No abstract available.
- Abou-Chebl A, Sung G, Barbut D, Torbey M. Local brain temperature reduction through intranasal cooling with the RhinoChill device: preliminary safety data in brain-injured patients. Stroke. 2011 Aug;42(8):2164-9. doi: 10.1161/STROKEAHA.110.613000. Epub 2011 Jun 16.
- Friedman MH, Peterson SJ, Behar CF, Zaidi Z. Intraoral chilling versus oral sumatriptan for acute migraine. Heart Dis. 2001 Nov-Dec;3(6):357-61. doi: 10.1097/00132580-200111000-00003.
- Sprouse-Blum AS, Gabriel AK, Brown JP, Yee MH. Randomized controlled trial: targeted neck cooling in the treatment of the migraine patient. Hawaii J Med Public Health. 2013 Jul;72(7):237-41.
- Zanchin G, Maggioni F, Granella F, Rossi P, Falco L, Manzoni GC. Self-administered pain-relieving manoeuvres in primary headaches. Cephalalgia. 2001 Sep;21(7):718-26. doi: 10.1046/j.1468-2982.2001.00199.x.
- Diamond S, Freitag FG. Cold as an adjunctive therapy for headache. Postgrad Med. 1986 Jan;79(1):305-9. doi: 10.1080/00325481.1986.11699255.
- Tsai MS, Barbut D, Tang W, Wang H, Guan J, Wang T, Sun S, Inderbitzen B, Weil MH. Rapid head cooling initiated coincident with cardiopulmonary resuscitation improves success of defibrillation and post-resuscitation myocardial function in a porcine model of prolonged cardiac arrest. J Am Coll Cardiol. 2008 May 20;51(20):1988-90. doi: 10.1016/j.jacc.2007.12.057. No abstract available.
- Ucler S, Coskun O, Inan LE, Kanatli Y. Cold Therapy in Migraine Patients: Open-label, Non-controlled, Pilot Study. Evid Based Complement Alternat Med. 2006 Dec;3(4):489-93. doi: 10.1093/ecam/nel035. Epub 2006 Jun 15.
- Robbins LD. Cryotherapy for headache. Headache. 1989 Oct;29(9):598-600. doi: 10.1111/j.1526-4610.1989.hed2909598.x.
- Lance JW. The controlled application of cold and heat by a new device (Migra-lief apparatus) in the treatment of headache. Headache. 1988 Aug;28(7):458-61. doi: 10.1111/j.1526-4610.1988.hed2807458.x. No abstract available.
- ABRAMSON DI. PHYSIOLOGIC BASIS FOR THE USE OF PHYSICAL AGENTS IN PERIPHERAL VASCULAR DISORDERS. Arch Phys Med Rehabil. 1965 Mar;46:216-44. No abstract available.
- Swenson C, Sward L, Karlsson J. Cryotherapy in sports medicine. Scand J Med Sci Sports. 1996 Aug;6(4):193-200. doi: 10.1111/j.1600-0838.1996.tb00090.x.
- Dolan MG, Thornton RM, Fish DR, Mendel FC. Effects of cold water immersion on edema formation after blunt injury to the hind limbs of rats. J Athl Train. 1997 Jul;32(3):233-7.
- Deal DN, Tipton J, Rosencrance E, Curl WW, Smith TL. Ice reduces edema. A study of microvascular permeability in rats. J Bone Joint Surg Am. 2002 Sep;84(9):1573-8.
- De Jong RH, Hershey WN, Wagman IH. Nerve conduction velocity during hypothermia in man. Anesthesiology. 1966 Nov-Dec;27(6):805-10. doi: 10.1097/00000542-196611000-00013. No abstract available.
- Merrick MA. Secondary injury after musculoskeletal trauma: a review and update. J Athl Train. 2002 Apr;37(2):209-17.
- Zachariassen KE. Hypothermia and cellular physiology. Arctic Med Res. 1991;50 Suppl 6:13-7.
- Numazaki M, Tominaga M. Nociception and TRP Channels. Curr Drug Targets CNS Neurol Disord. 2004 Dec;3(6):479-85. doi: 10.2174/1568007043336789.
- Zenker W, Kubik S. Brain cooling in humans--anatomical considerations. Anat Embryol (Berl). 1996 Jan;193(1):1-13. doi: 10.1007/BF00186829.
- Van den Brande P, De Coninck A, Lievens P. Skin microcirculation responses to severe local cooling. Int J Microcirc Clin Exp. 1997 Mar-Apr;17(2):55-60. doi: 10.1159/000179207.
- Boller M, Lampe JW, Katz JM, Barbut D, Becker LB. Feasibility of intra-arrest hypothermia induction: A novel nasopharyngeal approach achieves preferential brain cooling. Resuscitation. 2010 Aug;81(8):1025-30. doi: 10.1016/j.resuscitation.2010.04.005. Epub 2010 Jun 9.
- Wang H, Barbut D, Tsai MS, Sun S, Weil MH, Tang W. Intra-arrest selective brain cooling improves success of resuscitation in a porcine model of prolonged cardiac arrest. Resuscitation. 2010 May;81(5):617-21. doi: 10.1016/j.resuscitation.2010.01.027. Epub 2010 Mar 6.
- Yu T, Barbut D, Ristagno G, Cho JH, Sun S, Li Y, Weil MH, Tang W. Survival and neurological outcomes after nasopharyngeal cooling or peripheral vein cold saline infusion initiated during cardiopulmonary resuscitation in a porcine model of prolonged cardiac arrest. Crit Care Med. 2010 Mar;38(3):916-21. doi: 10.1097/CCM.0b013e3181cd1291.
- Guan J, Barbut D, Wang H, Li Y, Tsai MS, Sun S, Inderbitzen B, Weil MH, Tang W. A comparison between head cooling begun during cardiopulmonary resuscitation and surface cooling after resuscitation in a pig model of cardiac arrest. Crit Care Med. 2008 Nov;36(11 Suppl):S428-33. doi: 10.1097/ccm.0b013e31818a8876.
- Busch HJ, Eichwede F, Fodisch M, Taccone FS, Wobker G, Schwab T, Hopf HB, Tonner P, Hachimi-Idrissi S, Martens P, Fritz H, Bode Ch, Vincent JL, Inderbitzen B, Barbut D, Sterz F, Janata A. Safety and feasibility of nasopharyngeal evaporative cooling in the emergency department setting in survivors of cardiac arrest. Resuscitation. 2010 Aug;81(8):943-9. doi: 10.1016/j.resuscitation.2010.04.027. Epub 2010 Jun 2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3414
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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