Effects of Head and Neck Cooling and Heating on Fatigue in Multiple Sclerosis and Healthy Men

NCT ID: NCT06370403

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-04
• Study Completion Date: 2017-01-08

Brief Summary

Local head and neck cooling strategies can help reduce multiple sclerosis-related fatigue, while heating can exacerbate heat-related fatigue. However, no study has detailed the peripheral and central responses to head and neck cooling (at 18°C) and heating (at 43 ± 1°C next to the scalp and neck skin) during fatiguing isometric exercise in non-challenging ambient temperature in multiple sclerosis and healthy male subjects. In addition, there is a lack of data describing the effects of head and neck cooling/heating and strenuous exercise on blood markers, muscle temperature, motor accuracy, and rate of perceived exertion. The investigators hypothesized that: (i) men with multiple sclerosis would be more affected by central and peripheral fatigue compared to healthy subjects; (ii) local cooling will result in greater central fatigue but will be associated with greater peripheral fatigue, whereas heating will result in greater central and peripheral fatigue in multiple sclerosis men; (iv) local cooling and heating will have a greater effect on the release of stress hormones, rate of perceived exertion and motor accuracy compared to the control condition in both multiple sclerosis and healthy groups.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Cooling of the head and neck in multiple sclerosis and healthy subjects

Multiple sclerosis and healthy male subjects participated in the head and neck cooling program. During cooling procedure, the participant performed fatiguing isometric motor task with a head and neck cooling helmet at (18°C next to the head and neck skin).

Group Type: EXPERIMENTAL

Cooling of the head and neck

Intervention Type: OTHER

Cooling of the head and neck at 18°C next to the head and neck skin in multiple sclerosis and healthy subjects

Heating of the head and neck in multiple sclerosis and healthy subjects

Multiple sclerosis and healthy male subjects participated in the head and heating program. During heating procedure, the participant performed fatiguing isometric motor task with a head and neck heating helmet at (43°C± 1°C next to the head and neck skin).

Group Type: EXPERIMENTAL

Heating of the head and neck

Intervention Type: OTHER

Heating of the head and neck at 43 ± 1°C next to the head and neck skin in multiple sclerosis

Interventions

Cooling of the head and neck

Cooling of the head and neck at 18°C next to the head and neck skin in multiple sclerosis and healthy subjects

Intervention Type: OTHER

Heating of the head and neck

Heating of the head and neck at 43 ± 1°C next to the head and neck skin in multiple sclerosis

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Relapsing-remitting multiple sclerosis disease course according to McDonald criteria
• Expanded Disability Status Scale less than 4 points and Fatigue Severity Scale score greater than 5 points in participants with multiple sclerosis
• Males
• Age between 18 and 45 years
• Sufficient tolerance to electrical stimulation

Exclusion Criteria

• Physical limitations that would impair the ability to perform neuromuscular testing
• Mental disorders, such as depression or anxiety, due to their recognized association with fatigue
• Involvement in temperature manipulation program for ≥ 3 months
• Attending any excessive physical exercise or sports programs
• With blood/needle phobia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Lithuanian Sports University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gintarė Daukšaitė

Role: PRINCIPAL_INVESTIGATOR

Lithuanian Sports University

Locations

Lithuanian Sports University

Kaunas, , Lithuania

Countries

Lithuania

Other Identifiers

LithuanianSportsU-21

Identifier Type: -

Identifier Source: org_study_id