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

August 14, 2023 updated by: Adam Sprouse Blum, University of Vermont

Effect of a Novel Cooling Device on Brain Temperature

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Vermont
      • Burlington, Vermont, United States, 05401-1704
        • University of Vermont & State Agricultural College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cold circulated water
Cold water circulated through an adhesive wrap applied to the front of the neck.
Device: Cold circulated water
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).
Active Comparator: Body-temperature circulated water
Body-temperature water circulated through an adhesive wrap applied to the front of the neck.
Device: Body-temperature circulated water
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Collaborators

Becton, Dickinson and Company

Investigators

  • Principal Investigator: Adam S Sprouse Blum, MD, University of Vermont

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2021

Primary Completion (Actual)

March 3, 2022

Study Completion (Actual)

March 3, 2022

Study Registration Dates

First Submitted

June 28, 2021

First Submitted That Met QC Criteria

July 20, 2021

First Posted (Actual)

July 22, 2021

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00001312

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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