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

April 18, 2024 updated by: Lithuanian Sports University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lithuania
      • Kaunas, Lithuania, LT 44221
        • Lithuanian Sports University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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).
Other: 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
Experimental: 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).
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Every time in all conditions at the baseline
Body weight (kg)
Time Frame: Every time in all conditions at the baseline
Body weight (kg) was evaluated using Tanita Body Composition Analyzer (Japan).
Every time in all conditions at the baseline
Body fat (%)
Time Frame: Every time in all conditions at the baseline
Body fat (%) was assessed using Tanita Body Composition Analyzer (Japan).
Every time in all conditions at the baseline
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).
Every time in all conditions at the baseline
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.
Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
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).
Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
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).
Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
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).
Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
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).
Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
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.
Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
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.
Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
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).
Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
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.
Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
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.
Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
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.
Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
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 (±).
Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
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 (±).
Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Every time in all conditions at the baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lithuanian Sports University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gintarė Daukšaitė, Lithuanian Sports University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 4, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 8, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LithuanianSportsU-21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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