Healthy
Conditions
Keywords
targeted temperature management, brain temperature, brain cooling, neck cooling
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.
Interventions
DEVICECold 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).
DEVICEBody-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).
Sponsors
Becton, Dickinson and Company
University of Vermont
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brain Temperature | 60 minutes | During each intervention, core brain temperature was measured non-invasively, in one-minute increments, using MR thermometry. The change in brain temperature was calculated as the difference of differences between the cold and body-temperature interventions, after 1 hour. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Bedside Shivering Assessment | 120 minutes | — |
| Systolic Blood Pressure | 120 minutes | Change in systolic blood pressure during the intervention. |
| Diastolic Blood Pressure | 120 minutes | — |
| Heart Rate | 120 minutes | — |
Countries
United States
Participant flow
Recruitment details
22 subjects were screened for study eligibility between July, 2021 and February, 2022.
Pre-assignment details
Subjects were randomized to either the cold or body-temperature water arm at the MRI research center immediately prior to their first intervention.
Participants by arm
| Arm | Count |
|---|---|
| Analyzed Participants All analyzed participants. | 17 |
| Participants Used to Modify MRI Protocol Participants whose data was used to modify the MRI protocol. | 5 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Claustrophobia in the MRI machine. | 1 | 0 |
Baseline characteristics
| Characteristic | Analyzed Participants | Participants Used to Modify MRI Protocol | Total |
|---|---|---|---|
| Age, Continuous | 31.1 years STANDARD_DEVIATION 10.9 | 21.1 years STANDARD_DEVIATION 1.8 | 28.9 years STANDARD_DEVIATION 10.5 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 10 Participants | 2 Participants | 12 Participants |
| Sex: Female, Male Male | 7 Participants | 3 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 21 |
| other Total, other adverse events | 5 / 22 | 2 / 21 |
| serious Total, serious adverse events | 0 / 22 | 0 / 21 |
Outcome results
Primary
Change in Brain Temperature
During each intervention, core brain temperature was measured non-invasively, in one-minute increments, using MR thermometry. The change in brain temperature was calculated as the difference of differences between the cold and body-temperature interventions, after 1 hour.
Time frame: 60 minutes
Population: Two participants were excluded from the analyses, including one who was not able to complete the interventions due to claustrophobia, and one who had incomplete data due to documented head movement.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cold Circulated Water | Change in Brain Temperature | -0.23 degrees Celsius |
| Body-temperature Circulated Water | Change in Brain Temperature | -0.03 degrees Celsius |
p-value: 0.02t-test, 2 sided
Secondary
Diastolic Blood Pressure
Time frame: 120 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cold Circulated Water | Diastolic Blood Pressure | 2.8 mmHg |
| Body-temperature Circulated Water | Diastolic Blood Pressure | 0.8 mmHg |
Secondary
Heart Rate
Time frame: 120 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cold Circulated Water | Heart Rate | -2.0 beats per minute |
| Body-temperature Circulated Water | Heart Rate | 0.2 beats per minute |
Secondary
Modified Bedside Shivering Assessment
Time frame: 120 minutes
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cold Circulated Water | Modified Bedside Shivering Assessment | Number of participants with BSAS score = 0 (none) | 15 Participants |
| Cold Circulated Water | Modified Bedside Shivering Assessment | Number of participants with BSAS score = 1 (mild) | 0 Participants |
| Cold Circulated Water | Modified Bedside Shivering Assessment | Number of participants with BSAS score = 2 (moderate) | 0 Participants |
| Cold Circulated Water | Modified Bedside Shivering Assessment | Number of participants with BSAS score = 3 (severe) | 0 Participants |
| Body-temperature Circulated Water | Modified Bedside Shivering Assessment | Number of participants with BSAS score = 3 (severe) | 0 Participants |
| Body-temperature Circulated Water | Modified Bedside Shivering Assessment | Number of participants with BSAS score = 0 (none) | 15 Participants |
| Body-temperature Circulated Water | Modified Bedside Shivering Assessment | Number of participants with BSAS score = 2 (moderate) | 0 Participants |
| Body-temperature Circulated Water | Modified Bedside Shivering Assessment | Number of participants with BSAS score = 1 (mild) | 0 Participants |
Secondary
Systolic Blood Pressure
Change in systolic blood pressure during the intervention.
Time frame: 120 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cold Circulated Water | Systolic Blood Pressure | -1.7 mmHg |
| Body-temperature Circulated Water | Systolic Blood Pressure | 2.9 mmHg |