Hypothermia Due to Cold EnvironmentNCT04253730
Characterization of Corticospinal Excitability During Progressive Skin Cooling
A study testing Cold Stress in people with Hypothermia Due to Cold Environment, run by University of Manitoba at 1 site in Canada.
Trial summary
This study characterizes the changes in corticospinal excitability that accompany basic cold stress via skin cooling that result in reduced skin or core temperature and shivering. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypothermia Due to Cold Environment
- What is being tested?
- Cold Stress
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 22 Aug 2019to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult
- Right Handed
- Pass Magnetic Stimulation Safety Checklist
- Pass Medical Screening Questionnaire
Who cannot join
- Left Handed
- Any adverse responses to cold exposure (Raynaud's Syndrome)
- Cardiorespiratory Disease
Trial locations and contacts
1 site in 1 country.
Canada1 site
211 Max Bell Centre, University of Manitoba
Winnipeg, Manitoba, R3T 2N2
About this study
This study characterizes the changes in corticospinal excitability that accompany basic cold stress via skin cooling that result in reduced skin or core temperature and shivering.
Read the detailed description
Cold stress is known to impair both fine and gross motor movement. Reductions in performance may have life threatening consequences in survival situations where maintenance of muscle control is necessary. Much of the effects cooling has on muscle performance is directly due to its effects on muscle tissue itself, whereas less is known about the effects on the central nervous system. Therefore, the purpose of the study was to characterize corticospinal excitability that accompanies basic cold stress via progressive skin cooling, resulting in reductions in skin (Tsk) or core (Tco) temperature and shivering.
- Conditions
- Hypothermia Due to Cold Environment
- Being tested
- Cold Stress
- Keywords
- Body Temperature, Skin Temperature, Cooling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold StressOther
60-90 mins of cooling via a liquid perfused suit circulating ~4-10°C liquid.
| Study group | Role | What they receive |
|---|---|---|
| Control Condition | No intervention | Subjects will sit at rest wearing a liquid perfused suit containing thermoneutral water for 60 min. The suit will not be turned on during this period. |
| Cold Condition | Experimental | Subjects will be cooled for 60-90 min at ~ 4-10°C using a liquid perfused suit. Subjects will then be rewarmed for 30 min at ~ 41°C using the liquid perfused suit. Receives: Other: Cold Stress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Corticospinal Excitability
Motor Evoked Potentials (MEP) as a percentage of the maximal compound muscle action potential (Mmax) measured via MEG at the Biceps Brachii will serve as the indices of Corticospinal excitbaility
Measured: at 0, 20, 40, 60 and 90 minutes
Secondary outcomes (4)
Change in Spinal Excitability
Cervicomedullary Motor Evoked Potentials (CMEP) as a percentage of the maximal compound muscle action potential (Mmax) measured via MEG at the Biceps Brachii will serve as the indices of spinal excitability
Measured: at 0, 20, 40, 60 and 90 minutes
Change in Skin Temperature
Mean skin temperature of 7 sites
Measured: at 0, 20, 40, 60 and 90 minutes
Change in Core Temperature
Esophageal temperature is the most accurate method representing the temperature of the heart.
Measured: at 0, 20, 40, 60 and 90 minutes
Change in Metabolic Heat Production
Metabolic heat production serves as an objective way to quantify shivering thermogenesis.
Measured: at 0, 20, 40, 60 and 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start22 Aug 2019
- Primary completion1 Mar 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypothermia Due to Cold EnvironmentStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Repeat Measures
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Gordon Giesbrecht, University of Manitoba
- Investigators
- Gordon Giesbrecht, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253730
- Sponsor's protocol ID
- E2018:047 (HS21827)
- Status last verified
- Dec 2022
- First submitted
- 26 Nov 2019
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hurrie DMG, Talebian Nia M, Power K, Stecina K, Gardiner P, Lockyer E, Giesbrecht GG. Spinal and corticospinal excitability in response to reductions in skin and core temperatures via whole-body cooling. Appl Physiol Nutr Metab. 2022 Feb;47(2):195-205. doi: 10.1139/apnm-2021-0370. Epub 2021 Sep 28.
PubMed 34582724
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Corticospinal Excitability During Progressive Skin Cooling
- ClinicalTrials.gov ID
- NCT04253730
- Acronym / sponsor ID
- E2018:047 (HS21827)
- Conditions
- Hypothermia Due to Cold Environment
- Keywords
- Body Temperature, Skin Temperature, Cooling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study characterizes the changes in corticospinal excitability that accompany basic cold stress via skin cooling that result in reduced skin or core temperature and shivering.
Detailed description
Cold stress is known to impair both fine and gross motor movement. Reductions in performance may have life threatening consequences in survival situations where maintenance of muscle control is necessary. Much of the effects cooling has on muscle performance is directly due to its effects on muscle tissue itself, whereas less is known about the effects on the central nervous system. Therefore, the purpose of the study was to characterize corticospinal excitability that accompanies basic cold stress via progressive skin cooling, resulting in reductions in skin (Tsk) or core (Tco) temperature and shivering.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Repeat Measures
| Arm | Type | Receives |
|---|---|---|
| Control Condition | No intervention | –Subjects will sit at rest wearing a liquid perfused suit containing thermoneutral water for 60 min. The suit will not be turned on during this period. |
| Cold Condition | Experimental | Other: Cold StressSubjects will be cooled for 60-90 min at ~ 4-10°C using a liquid perfused suit. Subjects will then be rewarmed for 30 min at ~ 41°C using the liquid perfused suit. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult
- Right Handed
- Pass Magnetic Stimulation Safety Checklist
- Pass Medical Screening Questionnaire
Key exclusion criteria (3 listed)
- Left Handed
- Any adverse responses to cold exposure (Raynaud's Syndrome)
- Cardiorespiratory Disease
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 Stress60-90 mins of cooling via a liquid perfused suit circulating ~4-10°C liquid. | Other | Cold Condition |
Primary outcome
Change in Corticospinal Excitability
Time frame: at 0, 20, 40, 60 and 90 minutes
Motor Evoked Potentials (MEP) as a percentage of the maximal compound muscle action potential (Mmax) measured via MEG at the Biceps Brachii will serve as the indices of Corticospinal excitbaility
4 secondary outcomes
Change in Spinal Excitability
Time frame: at 0, 20, 40, 60 and 90 minutes
Change in Skin Temperature
Time frame: at 0, 20, 40, 60 and 90 minutes
Change in Core Temperature
Time frame: at 0, 20, 40, 60 and 90 minutes
Change in Metabolic Heat Production
Time frame: at 0, 20, 40, 60 and 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Derived from this study: PubMed 34582724Hurrie DMG, Talebian Nia M, Power K, Stecina K, Gardiner P, Lockyer E, Giesbrecht GG. Spinal and corticospinal excitability in response to reductions in skin and core temperatures via whole-body cooling. Appl Physiol Nutr Metab. 2022 Feb;47(2):195-205. doi: 10.1139/apnm-2021-0370. Epub 2021 Sep 28.
- 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.
Gordon Giesbrecht, PhD principal investigator
University of Manitoba
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 Stress in people with Hypothermia Due to Cold Environment, run by University of Manitoba at 1 site in Canada.
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 4 inclusion and 3 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 6 Dec 2022. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Corticospinal Excitability (time frame: at 0, 20, 40, 60 and 90 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 NCT04253730, which also lists 1 linked publication.
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 6 Dec 2022.