BrainCool-Migraine Intranasal Cooling Trial

NCT03167060 | Completed

• 1 other identifier: CP1628
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 4

Brief Summary

This study will be a randomised placebo controlled trial examining the effectiveness of using an intranasal evaporative cooling device (the RhinoChill intransal device) in providing relief of pain and symptoms of acute migraine.The treatment works by introducing cooling into the passageways of the nose through two small cannulas thereby cooling the local nasal tissue and the blood vessels which supply blood to the brain. This cooling effect will cause the blood vessels to constrict as well as stimulating special cold receptors that are thought to be involved in the relief of migraine, thereby providing both pain and associated symptomatic relief. In total, 90 patients randomised in a 1:1 fashio n will be recruited from three different NHS Trusts. The patients will have a 30-day period of data collection for their current migraine frequency, treatment and response to medication (with a minimum of 2 migraine attacks recorded) before starting the treatment phase with the RhinoChill Device. Treatment will be for 3 migraine attacks. Only a single treatment is allowed for the first attack, but on the second attack the patient may deliver 2 treatments with a gap of at least 2 hours between treatments, if indicated.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Participant is pain free at two hours following trial device treatment The patients' first treatment will be used for analysis of the superiority of the rate of patients pain free at two hours following treatment for those receiving the standard R

  The first treatment with the RhinoChill device will be used for analysis of the superiority of the rate of participants who are pain free at two hours following treatment for those receiving the standard RhinoChill® treatment. This will be compared to those participants who are randomised to receive sham device treatment. Likert scale questionnaire will record the outcome

  two hours

Secondary Outcomes (5)

• Percentage of patients pain free immediately after treatment (10 minutes), at 1 hour, and 24 hours following treatment

  10 minutes, 1 hour, 24 hours

• Headache response

  10 min, 1 hour, 2 hours, 24 hours

• relapse incidence

  2 hours, 48 hours

• Sustained pain freedom

  2 hours, 48 hours

• Total migraine freedom

  2 hours

Study Arms (2)

Active Rhinochill

ACTIVE COMPARATOR

Intranasal cooling device , using nasal cannula

Device: Active RhinoChill

Control Rhinochill

SHAM COMPARATOR

Intranasal cooling device , using nasal cannula (difference with active device not disclosed to maintain blindness)

Device: Control Rhinochill

Interventions

Active RhinoChill DEVICE

Participants will be provided with a RhinoChill® device (Active) and an Intranasal Migraine catheter. Once they have the RhinoChill® device, they are asked to treat the next two of your migraines with the device. This requires a maximum of 10 minute intra-nasal treatment as soon as possible after the start of your migraine. The participation in the trial will last until 3 migraine headaches have been treated with the RhinoChill® device.

Active Rhinochill

Control Rhinochill DEVICE

Participants will be provided with a RhinoChill® device (Sham) and an Intranasal Migraine catheter. Once they have the RhinoChill® device, they are asked to treat the next two of your migraines with the device. This requires a maximum of 10 minute intra-nasal treatment as soon as possible after the start of your migraine. The participation in the trial will last until 3 migraine headaches have been treated with the RhinoChill® device.

Control Rhinochill

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Years old 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 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

You may not qualify if:

• \< 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 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

Sponsors & Collaborators

• Cumbria Partnership NHS Foundation Trust: lead
• BrainCool AB: collaborator

Study Sites (4)

Neurosciences department, Penrith Hospital, Cumbria Partnership NHS Foundation Trust

Penrith, Cumbria, CA11 8HX, United Kingdom

Location

South tees Hospital

Middlesbrough, United Kingdom

Location

The Newcastle upon Tyne Hospitals

Newcastle upon Tyne, United Kingdom

Location

City Hospital, Sunderland, UK

Sunderland, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 11975819 BACKGROUND

• 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.

  PMID: 23901394 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 11594999 BACKGROUND

• 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.

  PMID: 3941818 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jitka Vanderpol, MD

  Cumbria Partnership NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Controls will undergo same treatment with the medical device, but it will be a sham treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Post-market clinical study of one or more CE marked devices within intended purposes, involving a change to standard care or randomisation between groups

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: May 25, 2017
• Study Start: May 8, 2017
• Primary Completion: January 31, 2019
• Study Completion: February 6, 2019
• Last Updated: February 11, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)