search
Back to results

Characterization of Corticospinal Excitability During Progressive Skin Cooling

Primary Purpose

Hypothermia Due to Cold Environment

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cold Stress
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypothermia Due to Cold Environment focused on measuring Body Temperature, Skin Temperature, Cooling

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • 211 Max Bell Centre, University of Manitoba

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Condition

Cold Condition

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Change in Skin Temperature
Mean skin temperature of 7 sites
Change in Core Temperature
Esophageal temperature is the most accurate method representing the temperature of the heart.
Change in Metabolic Heat Production
Metabolic heat production serves as an objective way to quantify shivering thermogenesis.

Full Information

First Posted
November 26, 2019
Last Updated
December 2, 2022
Sponsor
University of Manitoba
search

1. Study Identification

Unique Protocol Identification Number
NCT04253730
Brief Title
Characterization of Corticospinal Excitability During Progressive Skin Cooling
Official Title
Characterization of Corticospinal Excitability During Progressive Skin Cooling
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
August 22, 2019 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia Due to Cold Environment
Keywords
Body Temperature, Skin Temperature, Cooling

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Repeat Measures
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Condition
Arm Type
No Intervention
Arm Description
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.
Arm Title
Cold Condition
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cold Stress
Intervention Description
60-90 mins of cooling via a liquid perfused suit circulating ~4-10°C liquid.
Primary Outcome Measure Information:
Title
Change in Corticospinal Excitability
Description
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
Time Frame
at 0, 20, 40, 60 and 90 minutes
Secondary Outcome Measure Information:
Title
Change in Spinal Excitability
Description
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
Time Frame
at 0, 20, 40, 60 and 90 minutes
Title
Change in Skin Temperature
Description
Mean skin temperature of 7 sites
Time Frame
at 0, 20, 40, 60 and 90 minutes
Title
Change in Core Temperature
Description
Esophageal temperature is the most accurate method representing the temperature of the heart.
Time Frame
at 0, 20, 40, 60 and 90 minutes
Title
Change in Metabolic Heat Production
Description
Metabolic heat production serves as an objective way to quantify shivering thermogenesis.
Time Frame
at 0, 20, 40, 60 and 90 minutes
Other Pre-specified Outcome Measures:
Title
Change in Peripheral nerve excitability
Description
Excitability of the peripheral nerve measured via EMG at the biceps brachia ( the maximal compound motor action potential (Mmax).
Time Frame
at 0, 20, 40, 60 and 90 minutes
Title
Change in Maximal Voluntary Contraction of Elbow Flexors
Description
Maximal Isometric Force of elbow flexors measured in kg of force
Time Frame
at 0, 20, 40, 60 and 90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordon Giesbrecht, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
211 Max Bell Centre, University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3T 2N2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34582724
Citation
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.
Results Reference
derived

Learn more about this trial

Characterization of Corticospinal Excitability During Progressive Skin Cooling

We'll reach out to this number within 24 hrs