Effects of Head and Neck Cooling and Heating on Fatigue in Multiple Sc

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

CompletedNot a drug-phase studyRelapsing MSNCT06370403

What it found

No results found

We found no results in the registry or in papers.

This trial finished 10 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Cooling of the head and neck
  • Heating of the head and neck

What it measured

Main measures

  • Body weight (kg)

    Every time in all conditions at the baseline

    Physical function

  • Body fat (%)

    Every time in all conditions at the baseline

    Physical function

  • Body free fat mass (kg)

    Every time in all conditions at the baseline

    Physical function

  • Body mass index (kg/m2)

    Every time in all conditions at the baseline

  • Change in muscle temperature (°C)

    Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

  • Change in plasma cortisol (nmol/L) concentrations

    Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

  • Change in plasma dopamine (nmol/L) concentrations

    Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

  • Change in plasma prolactin (ng/mL) concentrations

    Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

  • Change in subjective rating of perceived exertion

    Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

  • Change in muscle activity (mV)

    Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

  • Change in muscle activity (Hz)

    Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

  • Change in voluntary torque (Nm)

    Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

    Physical function

  • Change in involuntary torque (Nm)

    Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

    Physical function

  • Change in muscle contraction and relaxation (ms)

    Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

  • Change in central activation ratio (percent)

    Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

  • Change in constant error

    Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

  • Change in absolute error

    Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

Other measures (1)

  • Height (m)

    Every time in all conditions at the baseline

Who could take part

Relapsing MS · 18 to 45

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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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History

    1. Started

      Feb 2014

    2. Main results due

      Mar 2016

    3. Finished

      Jan 2017

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