- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04253730
Characterization of Corticospinal Excitability During Progressive Skin Cooling
December 2, 2022 updated by: Dr.Gordon Giesbrecht, University of Manitoba
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3T 2N2
- 211 Max Bell Centre, University of Manitoba
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy adult
- Right Handed
- Pass Magnetic Stimulation Safety Checklist
- Pass Medical Screening Questionnaire
Exclusion Criteria:
- Left Handed
- Any adverse responses to cold exposure (Raynaud's Syndrome)
- Cardiorespiratory Disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Condition
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.
|
|
Experimental: Cold Condition
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.
|
60-90 mins of cooling via a liquid perfused suit circulating ~4-10°C liquid.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
at 0, 20, 40, 60 and 90 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Spinal Excitability
Time Frame: at 0, 20, 40, 60 and 90 minutes
|
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
|
at 0, 20, 40, 60 and 90 minutes
|
Change in Skin Temperature
Time Frame: at 0, 20, 40, 60 and 90 minutes
|
Mean skin temperature of 7 sites
|
at 0, 20, 40, 60 and 90 minutes
|
Change in Core Temperature
Time Frame: at 0, 20, 40, 60 and 90 minutes
|
Esophageal temperature is the most accurate method representing the temperature of the heart.
|
at 0, 20, 40, 60 and 90 minutes
|
Change in Metabolic Heat Production
Time Frame: at 0, 20, 40, 60 and 90 minutes
|
Metabolic heat production serves as an objective way to quantify shivering thermogenesis.
|
at 0, 20, 40, 60 and 90 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Peripheral nerve excitability
Time Frame: at 0, 20, 40, 60 and 90 minutes
|
Excitability of the peripheral nerve measured via EMG at the biceps brachia ( the maximal compound motor action potential (Mmax).
|
at 0, 20, 40, 60 and 90 minutes
|
Change in Maximal Voluntary Contraction of Elbow Flexors
Time Frame: at 0, 20, 40, 60 and 90 minutes
|
Maximal Isometric Force of elbow flexors measured in kg of force
|
at 0, 20, 40, 60 and 90 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gordon Giesbrecht, PhD, University of Manitoba
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 22, 2019
Primary Completion (Actual)
March 1, 2022
Study Completion (Actual)
June 1, 2022
Study Registration Dates
First Submitted
November 26, 2019
First Submitted That Met QC Criteria
January 31, 2020
First Posted (Actual)
February 5, 2020
Study Record Updates
Last Update Posted (Estimate)
December 6, 2022
Last Update Submitted That Met QC Criteria
December 2, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E2018:047 (HS21827)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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