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BrainCool-Migraine Intranasal Cooling Trial

NCT03167060 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2019-02-11

No results posted yet for this study

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

Interventions

DEVICE

Active RhinoChill

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.

DEVICE

Control Rhinochill

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.

Sponsors & Collaborators

  • BrainCool AB

    collaborator UNKNOWN

  • Cumbria Partnership NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Jitka Vanderpol, MD · Cumbria Partnership NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-08
Primary Completion
2019-01-31
Completion
2019-02-06

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03167060 on ClinicalTrials.gov