NCT04253730

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

December 6, 2022

Status Verified

December 1, 2022

Enrollment Period

2.5 years

First QC Date

November 26, 2019

Last Update Submit

December 2, 2022

Conditions

Keywords

Body Temperature, Skin Temperature, Cooling

Outcome Measures

Primary Outcomes (1)

  • 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

    at 0, 20, 40, 60 and 90 minutes

Secondary Outcomes (4)

  • Change in Spinal Excitability

    at 0, 20, 40, 60 and 90 minutes

  • Change in Skin Temperature

    at 0, 20, 40, 60 and 90 minutes

  • Change in Core Temperature

    at 0, 20, 40, 60 and 90 minutes

  • Change in Metabolic Heat Production

    at 0, 20, 40, 60 and 90 minutes

Other Outcomes (2)

  • Change in Peripheral nerve excitability

    at 0, 20, 40, 60 and 90 minutes

  • Change in Maximal Voluntary Contraction of Elbow Flexors

    at 0, 20, 40, 60 and 90 minutes

Study Arms (2)

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.

Other: Cold Stress

Interventions

60-90 mins of cooling via a liquid perfused suit circulating \~4-10°C liquid.

Cold Condition

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult
  • Right Handed
  • Pass Magnetic Stimulation Safety Checklist
  • Pass Medical Screening Questionnaire

You may not qualify if:

  • Left Handed
  • Any adverse responses to cold exposure (Raynaud's Syndrome)
  • Cardiorespiratory Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

211 Max Bell Centre, University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Cold-Shock Response

Intervention Hierarchy (Ancestors)

Stress, PhysiologicalPhysiological Phenomena

Study Officials

  • Gordon Giesbrecht, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Repeat Measures
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 26, 2019

First Posted

February 5, 2020

Study Start

August 22, 2019

Primary Completion

March 1, 2022

Study Completion

June 1, 2022

Last Updated

December 6, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations