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Completed

NCT Number: NCT04973085

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

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

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Vermont & State Agricultural College

Burlington, Vermont, 05401-1704, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cold circulated water

Device

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).

Body-temperature circulated water

Device

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).

Primary outcomes

  1. Change in Brain Temperature

    Time frame: 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 outcomes

  1. Modified Bedside Shivering Assessment

    Time frame: 120 minutes

  2. Systolic Blood Pressure

    Time frame: 120 minutes

    Change in systolic blood pressure during the intervention.

  3. Diastolic Blood Pressure

    Time frame: 120 minutes

  4. Heart Rate

    Time frame: 120 minutes

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • Becton, Dickinson and Company

Registry information

Official study title

Effect of a Novel Cooling Device on Brain Temperature

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 22, 2021
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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