NCT04973085

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

Effect of a Novel Cooling Device on Brain Temperature

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University of Vermont · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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).
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).

Timeline

• Start date: 2021-07-22
• Primary completion: 2022-03-03
• Completion: 2022-03-03
• First posted: 2021-07-22
• Last updated: 2023-09-13
• Results posted: 2023-09-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study