HealthyNCT04973085

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

A study testing Cold circulated water and Body-temperature circulated water in people with Healthy, run by University of Vermont at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study was to clarify whether neck cooling can be used to non-invasively lower brain temperature in healthy adults. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Cold circulated water and Body-temperature circulated water
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited States
Study dates: 22 Jul 2021to 3 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy adults aged 18-65 years

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Vermont & State Agricultural College
Burlington, Vermont, 05401-1704

Other trials in United States

About this study

Official title: Effect of a Novel Cooling Device on Brain Temperature

The objective of this study was to clarify whether neck cooling can be used to non-invasively lower brain temperature in healthy adults.

Read the 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.

Conditions: Healthy
Being tested: Cold circulated water, Body-temperature circulated water
Keywords: targeted temperature management, brain temperature, brain cooling, neck cooling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cold circulated waterDevice
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 waterDevice
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).

Study groups in NCT04973085
Study group	Role	What they receive
Cold circulated water	Experimental	Cold water circulated through an adhesive wrap applied to the front of the neck. Receives: Device: Cold circulated water
Body-temperature circulated water	Active comparator	Body-temperature water circulated through an adhesive wrap applied to the front of the neck. Receives: Device: Body-temperature circulated water

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 60 minutes

Secondary outcomes (4)

Modified Bedside Shivering Assessment
Measured: 120 minutes
Systolic Blood Pressure
Change in systolic blood pressure during the intervention.
Measured: 120 minutes
Diastolic Blood Pressure
Measured: 120 minutes
Heart Rate
Measured: 120 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jul 20213 Mar 2022

First posted22 Jul 2021
Study start22 Jul 2021
Primary completion3 Mar 2022
Study completion3 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (37)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04973085
Sponsor's protocol ID: STUDY00001312
Status last verified: Aug 2023
First submitted: 28 Jun 2021
Last updated: 13 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 25339859
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.
PubMed 7631955
Arrich J, Holzer M, Havel C, Mullner M, Herkner H. Hypothermia for neuroprotection in adults after cardiopulmonary resuscitation. Cochrane Database Syst Rev. 2016 Feb 15;2(2):CD004128. doi: 10.1002/14651858.CD004128.pub4.
PubMed 26878327
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.
PubMed 17184193
Natale JA, D'Alecy LG. Protection from cerebral ischemia by brain cooling without reduced lactate accumulation in dogs. Stroke. 1989 Jun;20(6):770-7. doi: 10.1161/01.str.20.6.770.
PubMed 2728044
Noguchi Y, Nishio S, Kawauchi M, Asari S, Ohmoto T. A new method of inducing selective brain hypothermia with saline perfusion into the subdural space: effects on transient cerebral ischemia in cats. Acta Med Okayama. 2002 Dec;56(6):279-86. doi: 10.18926/AMO/31690.
PubMed 12685856
Davidson JO, Wassink G, Yuill CA, Zhang FG, Bennet L, Gunn AJ. How long is too long for cerebral cooling after ischemia in fetal sheep? J Cereb Blood Flow Metab. 2015 May;35(5):751-8. doi: 10.1038/jcbfm.2014.259. Epub 2015 Jan 21.
PubMed 25605291
Kuluz JW, Gregory GA, Yu AC, Chang Y. Selective brain cooling during and after prolonged global ischemia reduces cortical damage in rats. Stroke. 1992 Dec;23(12):1792-6; discussion 1797. doi: 10.1161/01.str.23.12.1792.
PubMed 1448830
Dumitrascu OM, Lamb J, Lyden PD. Still cooling after all these years: Meta-analysis of pre-clinical trials of therapeutic hypothermia for acute ischemic stroke. J Cereb Blood Flow Metab. 2016 Jul;36(7):1157-64. doi: 10.1177/0271678X16645112. Epub 2016 Apr 18.
PubMed 27089911
Torok E, Klopotowski M, Trabold R, Thal SC, Plesnila N, Scholler K. Mild hypothermia (33 degrees C) reduces intracranial hypertension and improves functional outcome after subarachnoid hemorrhage in rats. Neurosurgery. 2009 Aug;65(2):352-9; discussion 359. doi: 10.1227/01.NEU.0000345632.09882.FF.
PubMed 19625915
Dietrich WD, Bramlett HM. Therapeutic hypothermia and targeted temperature management for traumatic brain injury: Experimental and clinical experience. Brain Circ. 2017 Oct-Dec;3(4):186-198. doi: 10.4103/bc.bc_28_17. Epub 2017 Dec 29.
PubMed 30276324
Bennett AE, Hoesch RE, DeWitt LD, Afra P, Ansari SA. Therapeutic hypothermia for status epilepticus: A report, historical perspective, and review. Clin Neurol Neurosurg. 2014 Nov;126:103-9. doi: 10.1016/j.clineuro.2014.08.032. Epub 2014 Sep 4.
PubMed 25240131
Schwab M, Bauer R, Zwiener U. Mild hypothermia prevents the occurrence of cytotoxic brain edema in rats. Acta Neurobiol Exp (Wars). 1998;58(1):29-35. doi: 10.55782/ane-1998-1256.
PubMed 9583185
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.
PubMed 28490655
Jacobs SE, Berg M, Hunt R, Tarnow-Mordi WO, Inder TE, Davis PG. Cooling for newborns with hypoxic ischaemic encephalopathy. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD003311. doi: 10.1002/14651858.CD003311.pub3.
PubMed 23440789

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of a Novel Cooling Device on Brain Temperature
ClinicalTrials.gov ID: NCT04973085
Acronym / sponsor ID: STUDY00001312
Conditions: Healthy
Keywords: targeted temperature management, brain temperature, brain cooling, neck cooling
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: University of VermontUniversity, hospital or other
Collaborators: Becton, Dickinson and Company
Study start: 22 Jul 2021 (actual)
Primary completion: 3 Mar 2022 (actual)
Study completion: 3 Mar 2022 (actual)
First posted: 22 Jul 2021 (actual)
Results: Posted 13 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cold circulated water	Experimental	Device: Cold circulated waterCold water circulated through an adhesive wrap applied to the front of the neck.
Body-temperature circulated water	Active comparator	Device: Body-temperature circulated waterBody-temperature water circulated through an adhesive wrap applied to the front of the neck.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Healthy adults aged 18-65 years

Key exclusion criteria (4 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cold circulated waterCold 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).	Device	Cold circulated water
Body-temperature circulated waterBody-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).	Device	Body-temperature circulated water

Primary outcome

Change in Brain Temperature
Time frame: 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.

4 secondary outcomes

Modified Bedside Shivering Assessment
Time frame: 120 minutes
Systolic Blood Pressure
Time frame: 120 minutes
Diastolic Blood Pressure
Time frame: 120 minutes
Heart Rate
Time frame: 120 minutes

Results and safety

Results posted to the registry on 13 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cold (Intervention 1) Then Body-temperature (Intervention 2) Circulated Water	10	9
Body-temperature (Intervention 1) Then Cold (Intervention 2) Circulated Water	12	12

Primary outcome: Change in Brain Temperature

Time frame: 60 minutes. Median (95% Confidence Interval). Unit: degrees Celsius

Measure	Cold Circulated Water n = 15	Body-temperature Circulated Water n = 15
Value	-0.23 (-0.37 to -0.10)	-0.03 (-0.14 to 0.09)

Cold Circulated Water vs Body-temperature Circulated Water: p = 0.02, t-test, 2 sided

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 120 minutes. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cold Circulated Water	0 of 22 (0%)	5 of 22 (22.7%)	0 of 22
Body-temperature Circulated Water	0 of 21 (0%)	2 of 21 (9.5%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25339859Wang 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.
Background: PubMed 7631955Wass 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.
Background: PubMed 26878327Arrich J, Holzer M, Havel C, Mullner M, Herkner H. Hypothermia for neuroprotection in adults after cardiopulmonary resuscitation. Cochrane Database Syst Rev. 2016 Feb 15;2(2):CD004128. doi: 10.1002/14651858.CD004128.pub4.
Background: PubMed 17184193Jiang 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.
Background: PubMed 2728044Natale JA, D'Alecy LG. Protection from cerebral ischemia by brain cooling without reduced lactate accumulation in dogs. Stroke. 1989 Jun;20(6):770-7. doi: 10.1161/01.str.20.6.770.
Background: PubMed 12685856Noguchi Y, Nishio S, Kawauchi M, Asari S, Ohmoto T. A new method of inducing selective brain hypothermia with saline perfusion into the subdural space: effects on transient cerebral ischemia in cats. Acta Med Okayama. 2002 Dec;56(6):279-86. doi: 10.18926/AMO/31690.
Background: PubMed 25605291Davidson JO, Wassink G, Yuill CA, Zhang FG, Bennet L, Gunn AJ. How long is too long for cerebral cooling after ischemia in fetal sheep? J Cereb Blood Flow Metab. 2015 May;35(5):751-8. doi: 10.1038/jcbfm.2014.259. Epub 2015 Jan 21.
Background: PubMed 1448830Kuluz JW, Gregory GA, Yu AC, Chang Y. Selective brain cooling during and after prolonged global ischemia reduces cortical damage in rats. Stroke. 1992 Dec;23(12):1792-6; discussion 1797. doi: 10.1161/01.str.23.12.1792.
Background: PubMed 27089911Dumitrascu OM, Lamb J, Lyden PD. Still cooling after all these years: Meta-analysis of pre-clinical trials of therapeutic hypothermia for acute ischemic stroke. J Cereb Blood Flow Metab. 2016 Jul;36(7):1157-64. doi: 10.1177/0271678X16645112. Epub 2016 Apr 18.
Background: PubMed 19625915Torok E, Klopotowski M, Trabold R, Thal SC, Plesnila N, Scholler K. Mild hypothermia (33 degrees C) reduces intracranial hypertension and improves functional outcome after subarachnoid hemorrhage in rats. Neurosurgery. 2009 Aug;65(2):352-9; discussion 359. doi: 10.1227/01.NEU.0000345632.09882.FF.
Background: PubMed 30276324Dietrich WD, Bramlett HM. Therapeutic hypothermia and targeted temperature management for traumatic brain injury: Experimental and clinical experience. Brain Circ. 2017 Oct-Dec;3(4):186-198. doi: 10.4103/bc.bc_28_17. Epub 2017 Dec 29.
Background: PubMed 25240131Bennett AE, Hoesch RE, DeWitt LD, Afra P, Ansari SA. Therapeutic hypothermia for status epilepticus: A report, historical perspective, and review. Clin Neurol Neurosurg. 2014 Nov;126:103-9. doi: 10.1016/j.clineuro.2014.08.032. Epub 2014 Sep 4.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Adam S Sprouse Blum, MD principal investigator

University of Vermont

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cold circulated water and Body-temperature circulated water in people with Healthy, run by University of Vermont at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Brain Temperature (time frame: 60 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04973085, which also lists 37 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.