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| Name | Class |
|---|---|
| Becton, Dickinson and Company | INDUSTRY |
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The objective of this study was to clarify whether neck cooling can be used to non-invasively lower brain temperature in healthy adults.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cold circulated water | Experimental | Cold water circulated through an adhesive wrap applied to the front of the neck. |
|
| Body-temperature circulated water | Active Comparator | Body-temperature water circulated through an adhesive wrap applied to the front of the neck. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold circulated water | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Bedside Shivering Assessment | 120 minutes | |
| Systolic Blood Pressure | Change in systolic blood pressure during the intervention. | 120 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam S Sprouse Blum, MD | University of Vermont | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vermont & State Agricultural College | Burlington | Vermont | 05401-1704 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25339859 | Background | Wang H, Wang B, Normoyle KP, Jackson K, Spitler K, Sharrock MF, Miller CM, Best C, Llano D, Du R. Brain temperature and its fundamental properties: a review for clinical neuroscientists. Front Neurosci. 2014 Oct 8;8:307. doi: 10.3389/fnins.2014.00307. eCollection 2014. | |
| 7631955 | Background | Wass CT, Lanier WL, Hofer RE, Scheithauer BW, Andrews AG. Temperature changes of > or = 1 degree C alter functional neurologic outcome and histopathology in a canine model of complete cerebral ischemia. Anesthesiology. 1995 Aug;83(2):325-35. doi: 10.1097/00000542-199508000-00013. |
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Subjects were randomized to either the cold or body-temperature water arm at the MRI research center immediately prior to their first intervention.
22 subjects were screened for study eligibility between July, 2021 and February, 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cold (Intervention 1) Then Body-temperature (Intervention 2) Circulated Water | Participants first underwent the intervention with cold circulated water. Then, on a separate day, they repeated the intervention with body-temperature water. |
| FG001 | Body-temperature (Intervention 1) Then Cold (Intervention 2) Circulated Water | Participants first underwent the intervention with body-temperature circulated water. Then, on a separate day, they repeated the intervention with cold water. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
|
| ||||||||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Analyzed Participants | All analyzed participants. |
| BG001 | Participants Used to Modify MRI Protocol | Participants whose data was used to modify the MRI protocol. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Median | 95% Confidence Interval | degrees Celsius | 60 minutes |
|
120 minutes
Adverse event information was collected immediately after each intervention, by asking participants: "Did you experience any adverse effects during the intervention? If yes, please explain."
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cold Circulated Water | Adverse events occurring during the cold intervention. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Claustrophobia in the MRI scanner | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Sprouse Blum, MD | University of Vermont | 8028478050 | Adam.Sprouse-Blum@uvmhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2021 | Jul 28, 2023 | Prot_SAP_000.pdf |
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|
| Body-temperature circulated water | Device | 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). |
|
| Diastolic Blood Pressure | 120 minutes |
| Heart Rate | 120 minutes |
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| 17184193 | Background | Jiang JY, Xu W, Yang PF, Gao GY, Gao YG, Liang YM, Yin XL, Zhu C. Marked protection by selective cerebral profound hypothermia after complete cerebral ischemia in primates. J Neurotrauma. 2006 Dec;23(12):1847-56. doi: 10.1089/neu.2006.23.1847. |
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| 23989182 | Background | Geurts M, Macleod MR, Kollmar R, Kremer PH, van der Worp HB. Therapeutic hypothermia and the risk of infection: a systematic review and meta-analysis. Crit Care Med. 2014 Feb;42(2):231-42. doi: 10.1097/CCM.0b013e3182a276e8. |
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| 28830757 | Background | Kurisu K, Yenari MA. Therapeutic hypothermia for ischemic stroke; pathophysiology and future promise. Neuropharmacology. 2018 May 15;134(Pt B):302-309. doi: 10.1016/j.neuropharm.2017.08.025. Epub 2017 Aug 19. |
| 17212971 | Background | Ohta H, Terao Y, Shintani Y, Kiyota Y. Therapeutic time window of post-ischemic mild hypothermia and the gene expression associated with the neuroprotection in rat focal cerebral ischemia. Neurosci Res. 2007 Mar;57(3):424-33. doi: 10.1016/j.neures.2006.12.002. Epub 2007 Jan 8. |
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| 24578693 | Background | Nybo L, Wanscher M, Secher NH. Influence of intranasal and carotid cooling on cerebral temperature balance and oxygenation. Front Physiol. 2014 Feb 27;5:79. doi: 10.3389/fphys.2014.00079. eCollection 2014. |
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| 23171713 | Background | Harris B, Andrews PJ, Murray GD, Forbes J, Moseley O. Systematic review of head cooling in adults after traumatic brain injury and stroke. Health Technol Assess. 2012;16(45):1-175. doi: 10.3310/hta16450. |
| COMPLETED |
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| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Participants undergoing the intervention with body-temperature circulated water. |
|
|
|
| Secondary | Modified Bedside Shivering Assessment | Posted | Count of Participants | Participants | 120 minutes |
|
|
|
| Secondary | Systolic Blood Pressure | Change in systolic blood pressure during the intervention. | Posted | Median | 95% Confidence Interval | mmHg | 120 minutes |
|
|
|
| Secondary | Diastolic Blood Pressure | Posted | Median | 95% Confidence Interval | mmHg | 120 minutes |
|
|
|
| Secondary | Heart Rate | Posted | Median | 95% Confidence Interval | beats per minute | 120 minutes |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 5 |
| 22 |
| EG001 | Body-temperature Circulated Water | Adverse events occurring during the body-temperature intervention. | 0 | 21 | 0 | 21 | 2 | 21 |
| Skin discomfort | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Stiff neck | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Ear and labyrinth disorders | Systematic Assessment |
|
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| Number of participants with BSAS score = 2 (moderate) |
|
| Number of participants with BSAS score = 3 (severe) |
|