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

Lithuanian Sports University

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Other: Heating of the head and neck; Other: Cooling of the head and neck

Study type: Interventional

Funder types: Other

Identifiers

NCT06370403

LithuanianSportsU-21

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

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

Experimental group

Description:

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).

Treatment:

Other: Cooling of the head and neck

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

Experimental group

Description:

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).

Treatment:

Other: Heating of the head and neck