Neck Cooling as a Non-Invasive Method to Lower Brain Temperature in Healthy Adults
NCT ID: NCT04973085
Last Updated: 2023-09-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2021-07-22
2022-03-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Cold circulated water
Cold water circulated through an adhesive wrap applied to the front of the neck.
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).
Body-temperature circulated water
Body-temperature water circulated through an adhesive wrap applied to the front of the neck.
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).
Interventions
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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).
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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
18 Years
65 Years
ALL
Yes
Sponsors
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Becton, Dickinson and Company
INDUSTRY
University of Vermont
OTHER
Responsible Party
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Adam Sprouse Blum
Assistant Professor of Neurological Sciences
Principal Investigators
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Adam S Sprouse Blum, MD
Role: PRINCIPAL_INVESTIGATOR
University of Vermont
Locations
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University of Vermont & State Agricultural College
Burlington, Vermont, United States
Countries
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References
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Geocadin RG, Wijdicks E, Armstrong MJ, Damian M, Mayer SA, Ornato JP, Rabinstein A, Suarez JI, Torbey MT, Dubinsky RM, Lazarou J. Practice guideline summary: Reducing brain injury following cardiopulmonary resuscitation: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. 2017 May 30;88(22):2141-2149. doi: 10.1212/WNL.0000000000003966. Epub 2017 May 10.
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STUDY00001312
Identifier Type: -
Identifier Source: org_study_id
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