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

NCT04973085 | Completed Results FDA Device

• 1 other identifier: STUDY00001312
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

targeted temperature management; brain temperature; brain cooling; neck cooling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Modified Bedside Shivering Assessment

  120 minutes

• Systolic Blood Pressure

  120 minutes

• Diastolic Blood Pressure

  120 minutes

• Heart Rate

  120 minutes

Study Arms (2)

Cold circulated water

EXPERIMENTAL

Cold water circulated through an adhesive wrap applied to the front of the neck.

Device: Cold circulated water

Body-temperature circulated water

ACTIVE COMPARATOR

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

Device: Body-temperature circulated water

Interventions

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).

Cold circulated water

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).

Body-temperature circulated water

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults aged 18-65 years

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Vermont: lead
• Becton, Dickinson and Company: collaborator

Study Sites (1)

University of Vermont & State Agricultural College

Burlington, Vermont, 05401-1704, United States

Location

Related Publications (37)

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  BACKGROUND

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Results Point of Contact

• Title: Adam Sprouse Blum, MD
• Organization: University of Vermont

Adam.Sprouse-Blum@uvmhealth.org

8028478050

Study Officials

• Adam S Sprouse Blum, MD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurological Sciences

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 22, 2021
• Study Start: July 22, 2021
• Primary Completion: March 3, 2022
• Study Completion: March 3, 2022
• Last Updated: September 13, 2023
• Results First Posted: September 13, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)