Characterization of Corticospinal Excitability During Progressive Skin Cooling

Hypothermia Due to Cold Environment Clinical Trial

Official title:

Characterization of Corticospinal Excitability During Progressive Skin Cooling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04253730
• Other study ID #: E2018:047 (HS21827)
• Status: Completed
• Phase: N/A
• Start date: August 22, 2019
• Est. completion date: June 1, 2022

Study information

• Verified date: December 2022
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia Due to Cold Environment

Intervention

Other:
• Cold Stress
60-90 mins of cooling via a liquid perfused suit circulating ~4-10°C liquid.

Locations

Country	Name	City	State
Canada	211 Max Bell Centre, University of Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Peripheral nerve excitability	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
Other	Change in Maximal Voluntary Contraction of Elbow Flexors	Maximal Isometric Force of elbow flexors measured in kg of force	at 0, 20, 40, 60 and 90 minutes
Primary	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	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	at 0, 20, 40, 60 and 90 minutes
Secondary	Change in Skin Temperature	Mean skin temperature of 7 sites	at 0, 20, 40, 60 and 90 minutes
Secondary	Change in Core Temperature	Esophageal temperature is the most accurate method representing the temperature of the heart.	at 0, 20, 40, 60 and 90 minutes
Secondary	Change in Metabolic Heat Production	Metabolic heat production serves as an objective way to quantify shivering thermogenesis.	at 0, 20, 40, 60 and 90 minutes