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Completed

NCT Number: NCT06370403

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fatigue Immune System Diseases Motor Activity Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Lithuanian Sports University

Kaunas, LT 44221, Lithuania

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cooling of the head and neck

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

Other

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

Primary outcomes

  1. Body weight (kg)

    Time frame: Every time in all conditions at the baseline

    Body weight (kg) was evaluated using Tanita Body Composition Analyzer (Japan).

  2. Body fat (%)

    Time frame: Every time in all conditions at the baseline

    Body fat (%) was assessed using Tanita Body Composition Analyzer (Japan).

  3. Body free fat mass (kg)

    Time frame: Every time in all conditions at the baseline

    Body free fat mass (kg) was evaluated using Tanita Body Composition Analyzer (Japan).

  4. Body mass index (kg/m2)

    Time frame: Every time in all conditions at the baseline

    The body mass index (in kg/m2) was defined as the body mass divided by the square of the body height.

  5. Change in muscle temperature (°C)

    Time frame: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

    Muscle temperature was measured using a needle microprobe (Intramuscular Probe MKA, thermometer model DM-852, Ellab) inserted approximately 3 cm beneath the skin surface into the vastus lateralis muscle of the right leg.

  6. Change in plasma cortisol (nmol/L) concentrations

    Time frame: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

    Plasma cortisol concentrations (nmol/L) were measured using an AIA-2000 automated enzyme immunoassay analyser (Tosoh Corp, Tokyo, Japan).

  7. Change in plasma dopamine (nmol/L) concentrations

    Time frame: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

    Dopamine concentrations (nmol/L) were measured using a kit for dopamine enzyme-linked immunosorbent assay (ELISA) (IBL, Hamburg, Germany).

  8. Change in plasma prolactin (ng/mL) concentrations

    Time frame: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

    Prolactin levels (ng/mL) were measured using a kit for prolactin ELISA (IBL) and Gemini analyzer (Stratec Biomedical GmbH, Germany).

  9. Change in subjective rating of perceived exertion

    Time frame: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

    Perceived exertion was assessed using the Borg scale, ranging from 6 (no exertion) to 20 (maximum exertion).

  10. Change in muscle activity (mV)

    Time frame: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

    Vastus medialis and vastus lateralis electromyographic (EMG) amplitude (in mV) parameters of muscular activity were measured using surface EMG (Biometrics, UK) thorough neuromuscular function assessment.

  11. Change in muscle activity (Hz)

    Time frame: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

    Vastus medialis and vastus lateralis muscles electromyographic (EMG) frequency (in Hz) parameters of muscular activity were measured using surface EMG (Biometrics, UK) thorough neuromuscular function assessment.

  12. Change in voluntary torque (Nm)

    Time frame: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

    Isometric and isokinetic voluntary torques (in Nm) of the quadriceps muscles were measured using an isokinetic dynamometer (Biodex Medical Systems, USA).

  13. Change in involuntary torque (Nm)

    Time frame: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

    Involuntary torque of the quadriceps muscles were measured using an isokinetic dynamometer (Biodex Medical Systems, USA) and a high-voltage stimulator (Digitimer DS7A, Digitimer, UK). Peak torques (in Nm) induced by electrical stimulation at 20 Hz,at 100 Hz, and at TT100 were measured.

  14. Change in muscle contraction and relaxation (ms)

    Time frame: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

    The contraction and half-relaxation time (in ms) were measured in 100Hz stimulated contractions.

  15. Change in central activation ratio (percent)

    Time frame: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

    To evaluate central activation ratio (CAR), a TT-100 Hz stimuli was superimposed on the maximal voluntary contraction (MVC), and the CAR was computed using the following equation: CAR = MVC/(MVC+TT-100 Hz) × 100percent, where where a CAR of 100 percent indicates complete activation of the exercising muscle and a CAR < 100 percent indicates central activation failure or inhibition.

  16. Change in constant error

    Time frame: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

    The accuracy of the intermittent isometric contraction tasks was calculated as a constant error. Constant error = ∑(xi - T)/n where xi is the motor task performed (N·m); T is the target quantity, i.e., the motor task required; n is the number of trials; and Σ indicates the mean that was calculated considering the algebraic symbols (±).

  17. Change in absolute error

    Time frame: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

    The absolute error specifies the absolute deviation from the required target force. Absolute error = ∑|xi - T|/n where xi is the motor task performed (N·m); T is the target quantity, i.e., the motor task required; n is the number of trials; and vertical brackets Σ | | indicate the mean that was calculated without considering the algebraic symbols (±).

Secondary outcomes

  1. Height (m)

    Time frame: Every time in all conditions at the baseline

    Height (in m) was measured using a Harpenden anthropometer set (Holtain Ltd, UK)

Sponsors and collaborators

Lead sponsor

Lithuanian Sports University

Other

Registry information

Official study title

Effects of Head and Neck Cooling and Heating on Central and Peripheral Fatigue, Motor Accuracy and Blood Markers of Stress in Multiple Sclerosis and Healthy Men

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Apr 17, 2024
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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