protocolSection identificationModule nctId: NCT06370403, orgStudyIdInfo id: LithuanianSportsU-21, briefTitle: Effects of Head and Neck Cooling and Heating on Fatigue in Multiple Sclerosis and Healthy Men, statusModule overallStatus: COMPLETED, startDateStruct date: 2014-02-04, primaryCompletionDateStruct date: 2016-03-01, completionDateStruct date: 2017-01-08, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Lithuanian Sports University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: PREVENTION, maskingInfo masking: NONE, maskingDescription: The researchers who analyzed the venous blood samples were blinded., enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Cooling of the head and neck, interventions name: Heating of the head and neck, outcomesModule primaryOutcomes measure: Body weight (kg), primaryOutcomes measure: Body fat (%), primaryOutcomes measure: Body free fat mass (kg), primaryOutcomes measure: Body mass index (kg/m2), primaryOutcomes measure: Change in muscle temperature (°C), primaryOutcomes measure: Change in plasma cortisol (nmol/L) concentrations, primaryOutcomes measure: Change in plasma dopamine (nmol/L) concentrations, primaryOutcomes measure: Change in plasma prolactin (ng/mL) concentrations, primaryOutcomes measure: Change in subjective rating of perceived exertion, primaryOutcomes measure: Change in muscle activity (mV), primaryOutcomes measure: Change in muscle activity (Hz), primaryOutcomes measure: Change in voluntary torque (Nm), primaryOutcomes measure: Change in involuntary torque (Nm), primaryOutcomes measure: Change in muscle contraction and relaxation (ms), primaryOutcomes measure: Change in central activation ratio (percent), primaryOutcomes measure: Change in constant error, primaryOutcomes measure: Change in absolute error, secondaryOutcomes measure: Height (m), eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Lithuanian Sports University, city: Kaunas, zip: LT 44221, country: Lithuania, geoPoint lat: 54.90272, lon: 23.90961, hasResults: False