Clinical trial NCT04973085: Neck Cooling as a Non-Invasive Method to Lower Brain Temperature in Healthy Adults
Official title: Effect of a Novel Cooling Device on Brain Temperature
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: targeted temperature management
brain temperature
brain cooling
neck cooling
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: Becton, Dickinson and Company
First posted: 2021-07-22
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Brain Temperature
timeFrame: 60 minutes
Secondary outcomes:
measure: Modified Bedside Shivering Assessment
timeFrame: 120 minutes
measure: Systolic Blood Pressure
timeFrame: 120 minutes
measure: Diastolic Blood Pressure
timeFrame: 120 minutes
measure: Heart Rate
timeFrame: 120 minutes
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont & State Agricultural College
state: Vermont
Study officials:
affiliation: University of Vermont
name: Adam S Sprouse Blum, MD
role: PRINCIPAL_INVESTIGATOR
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