Neck Cooling as a Non-Invasive Method to Lower Brain Temperature in Healthy Adults

Study Overview
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Brief Summary
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The objective of this study was to clarify whether neck cooling can be used to non-invasively lower brain temperature in healthy adults.

Detailed Description
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Healthy adults were randomized to undergo an intervention in which either cold or body-temperature water was circulated through an adhesive wrap applied to the front of their necks, overlying the carotid arteries, for 120 minutes. After their first intervention, subjects crossed over (i.e., cold went to body-temperature, and vice-versa) on a separate day. Brain temperature was measured in one-minute intervals using MR thermometry.

Official Title
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Effect of a Novel Cooling Device on Brain Temperature

Conditions
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Healthy

Intervention / Treatment
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* Device: Cold circulated water
* Device: Body-temperature circulated water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults aged 18-65 years Exclusion Criteria: Pregnancy Contraindications to MRI (e.g. claustrophobia, metallic implants, etc.) Signs of ulcerations, burns, hives or rash where the neck wrap is applied History of Raynaud's disease, venous or arterial occlusive disease (e.g. carotid stenosis), cryoprecipitation disorders (e.g. cryoglobulinemia) and pernio (also known as chilblains)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cold circulated water<br>Cold water circulated through an adhesive wrap applied to the front of the neck. | Device: Cold circulated water<br>* Cold water was circulated through an adhesive wrap applied to the front of the neck, overlying the carotid arteries, for 120 minutes. MR thermometry was used to measure core brain temperature in 1-minute intervals throughout the intervention. On a different day, subjects crossed over and repeated the intervention in the other study arm (i.e., cold went to body-temperature, and vice-versa).<br>|
| Active Comparator: Body-temperature circulated water<br>Body-temperature water circulated through an adhesive wrap applied to the front of the neck. | Device: Body-temperature circulated water<br>* Body-temperature water was circulated through an adhesive wrap applied to the front of the neck, overlying the carotid arteries, for 120 minutes. MR thermometry was used to measure core brain temperature in 1-minute intervals throughout the intervention. On a different day, subjects crossed over and repeated the intervention in the other study arm (i.e., cold went to body-temperature, and vice-versa).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Brain Temperature | During each intervention, core brain temperature was measured non-invasively, in one-minute increments, using MR thermometry. The change in brain temperature was calculated as the difference of differences between the cold and body-temperature interventions, after 1 hour. | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Bedside Shivering Assessment |  | 120 minutes | 
| Systolic Blood Pressure | Change in systolic blood pressure during the intervention. | 120 minutes | 
| Diastolic Blood Pressure |  | 120 minutes | 
| Heart Rate |  | 120 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain temperature, targeted temperature management, brain cooling, neck cooling