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

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ClinicalTrials.gov Identifier: NCT04973085
Recruitment Status : Not yet recruiting
First Posted : July 22, 2021
Last Update Posted : July 22, 2021
Sponsor:
Collaborator:
Becton, Dickinson and Company
Information provided by (Responsible Party):
Adam Sprouse Blum, University of Vermont

Brief Summary:
The objective of this study is to attempt to non-invasively cool the brain by applying surface cooling to the neck. Cooling will be achieved by circulating cold water through an adhesive wrap applied to the front of the neck. The neck wrap will be connected, via a set of tubes, to a water circulation device. Brain temperature will be measured non-invasively using magnetic resonance imaging (MRI). Subjects who take part in this study will be asked to complete two research visits to the MRI Research Center, ideally within 7 days of each other. During one of the visits, cold water (experimental group) would be circulated through the wrap. During the other visit, body temperature water (active comparator) would be circulated through the wrap. In both cases, the duration of water circulation would be 2 hours.

Condition or disease Intervention/treatment Phase
Healthy Device: Cold or body temperature circulated water Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of a Novel Cooling Device on Brain Temperature
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: Cold circulated water
Research staff will help position the participant on the bed of the MRI scanner. An adhesive wrap will be applied to the front of the participant's neck. Participants will be in constant communication with study personnel throughout the intervention by means of a 2-way intercom. When ready, the water circulation machine will be turned on. Water will circulate from the machine, through a long set of tubes, to the neck wrap, then back to the machine in a closed-loop system. At the beginning of the intervention, body temperature water will be circulated through the neck wrap. Over 5-10 minutes, the study coordinator and the participant will work together to slowly lower the temperature of the circulated water to identify the lowest tolerable temperature. The participant will be maintained at the lowest tolerable temperature for the remainder of the 2 hour intervention, and can adjust the temperature of the circulated water as often as desired throughout the study.
Device: Cold or body temperature circulated water

Water will be circulated through an adhesive wrap, applied to the front of the participant's neck, for 2 hours in either the cold (experimental) or body temperature (active comparator) study arm.

Subject's will be randomized to one study arm, then cross over to the other study arm after completion of their first intervention.


Active Comparator: Body temperature circulated water
The procedure for the body temperature study arm is identical to the cold study arm, except the water temperature will be kept at body temperature for the duration of the 2 hour intervention.
Device: Cold or body temperature circulated water

Water will be circulated through an adhesive wrap, applied to the front of the participant's neck, for 2 hours in either the cold (experimental) or body temperature (active comparator) study arm.

Subject's will be randomized to one study arm, then cross over to the other study arm after completion of their first intervention.





Primary Outcome Measures :
  1. Change in brain temperature [ Time Frame: 120 minutes ]
    During each intervention, core brain temperature will be measured non-invasively, in one-minute increments, using MR thermometry.


Secondary Outcome Measures :
  1. Effect of body mass index (BMI) on change in brain temperature [ Time Frame: Through study completion, an average of 1 week. ]
    Prior to each intervention, height will be measured to the nearest 1/10th of a centimeter using a stadiometer, weight will be measured to the nearest 1/10th of a kilogram using a hospital scale.

  2. Effect of neck circumference on change in brain temperature [ Time Frame: Through study completion, an average of 1 week. ]
    Prior to each intervention, neck circumference will be measured to the nearest 1/10th of a centimeter using a self-retracting inelastic tape measure.

  3. Effect of distance from skin surface to carotid artery on change in brain temperature [ Time Frame: Through study completion, an average of 1 week. ]
    Prior to each intervention, distance from skin surface to carotid artery will be measured to the nearest 1/10th of a centimeter on MRI cross section as the shortest distance from the wall of the common carotid artery to the skin, measured 2 cm below the carotid bifurcation.

  4. Tolerability of the intervention [ Time Frame: Through study completion, an average of 1 week. ]
    After each intervention, subjects will be asked: "On a scale of 0 to 10, where 0 means no discomfort at all and 10 means intolerable discomfort, please rate your overall discomfort during the test."

  5. Adverse effects [ Time Frame: Through study completion, an average of 1 week. ]
    After each intervention, subjects will be asked: "Did you experience any adverse effects during the intervention?" YES NO. If yes, please explain.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults age 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04973085


Contacts
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Contact: Adam S Sprouse Blum, MD 802-847-8050 Adam.Sprouse-Blum@uvmhealth.org
Contact: Donna Silver, CIP 802-656-5040 Donna.Silver@uvm.edu

Locations
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United States, Vermont
University of Vermont & State Agricultural College
Burlington, Vermont, United States, 05401-1704
Contact: Adam S Sprouse Blum, MD    802-847-8050    Adam.Sprouse-Blum@uvmhealth.org   
Sponsors and Collaborators
University of Vermont
Becton, Dickinson and Company
Investigators
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Principal Investigator: Adam S Sprouse Blum, MD University of Vermont
Publications:
Hall, L. D., & Talagala, S. L. (1985). Mapping of pH and temperature distribution using chemical-shift-resolved tomography. Journal of Magnetic Resonance (1969), 65(3), 501-505.

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Responsible Party: Adam Sprouse Blum, Assistant Professor of Neurological Sciences, University of Vermont
ClinicalTrials.gov Identifier: NCT04973085    
Other Study ID Numbers: STUDY00001312
First Posted: July 22, 2021    Key Record Dates
Last Update Posted: July 22, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Adam Sprouse Blum, University of Vermont:
targeted temperature management
prehospital cooling
brain cooling
neck cooling