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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: Cold circulated water; Device: Body-temperature circulated water

• Registration Number: NCT04973085
• Lead Sponsor: University of Vermont

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-06-28
• Study First Submitted QC: 2021-07-20
• Study Start: 2021-07-22
• Study First Posted: 2021-07-22
• Primary Completion: 2022-03-03
• Study Completion: 2022-03-03
• Status Verified: 2023-08
• Results First Submitted: 2023-08-14
• Results First Submitted QC: 2023-08-14
• Last Update Submitted: 2023-08-14
• Results First Posted: 2023-09-13
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Healthy adults aged 18-65 years

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cold circulated water	Cold circulated water	Cold water circulated through an adhesive wrap applied to the front of the neck.
Body-temperature circulated water	Body-temperature circulated water	Body-temperature water circulated through an adhesive wrap applied to the front of the neck.

Primary Outcome Measures

Name	Time	Method
Change in Brain Temperature	60 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Diastolic Blood Pressure	120 minutes
Heart Rate	120 minutes
Modified Bedside Shivering Assessment	120 minutes
Systolic Blood Pressure	120 minutes	Change in systolic blood pressure during the intervention.

Trial Locations

Locations (1)

University of Vermont & State Agricultural College; 🇺🇸 Burlington, Vermont, United States