N/A
N=22
Neck Cooling as a Non-Invasive Method to Lower Brain Temperature in Healthy Adults
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04973085 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Change in Brain Temperature — -0.23; -0.03 degrees Celsius — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cold circulated water (Device); Body-temperature circulated water (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Vermont
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Brain Temperature |
-0.23; -0.03 | 0.02 sig |
| SECONDARY Modified Bedside Shivering Assessment |
15; 15; 0; 0; 0; 0 | — |
| SECONDARY Systolic Blood Pressure |
-1.7; 2.9 | — |
| SECONDARY Diastolic Blood Pressure |
2.8; 0.8 | — |
| SECONDARY Heart Rate |
-2.0; 0.2 | — |
Summary
The objective of this study was to clarify whether neck cooling can be used to non-invasively lower brain temperature in healthy adults.
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)
Data sourced from ClinicalTrials.gov (NCT04973085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.