Multiple SclerosisNCT06370403
Effects of Head and Neck Cooling and Heating on Fatigue in Multiple Sclerosis and Healthy Men
A study testing Cooling of the head and neck and Heating of the head and neck in people with Multiple Sclerosis, run by Lithuanian Sports University at 1 site in Lithuania.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Cooling of the head and neck and Heating of the head and neck
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteLithuania
- Study dates
- 4 Feb 2014to 8 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Cooling of the head and neck, Heating of the head and neck
- Keywords
- Multiple sclerosis, Cooling, Heating, Fatigue, Exercise
- Medical subject headings
- Multiple Sclerosis, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooling of the head and neckOther
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 neckOther
Heating of the head and neck at 43 ± 1°C next to the head and neck skin in multiple sclerosis
| Study group | Role | What they receive |
|---|---|---|
| Cooling of the head and neck in multiple sclerosis and healthy subjects | Experimental | 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). Receives: Other: Cooling of the head and neck |
| Heating of the head and neck in multiple sclerosis and healthy subjects | Experimental | 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). Receives: Other: Heating of the head and neck |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight (kg)
Body weight (kg) was evaluated using Tanita Body Composition Analyzer (Japan).
Measured: Every time in all conditions at the baseline
Body fat (%)
Body fat (%) was assessed using Tanita Body Composition Analyzer (Japan).
Measured: Every time in all conditions at the baseline
Body free fat mass (kg)
Body free fat mass (kg) was evaluated using Tanita Body Composition Analyzer (Japan).
Measured: Every time in all conditions at the baseline
Body mass index (kg/m2)
The body mass index (in kg/m2) was defined as the body mass divided by the square of the body height.
Measured: Every time in all conditions at the baseline
Change in muscle temperature (°C)
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.
Measured: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Change in plasma cortisol (nmol/L) concentrations
Plasma cortisol concentrations (nmol/L) were measured using an AIA-2000 automated enzyme immunoassay analyser (Tosoh Corp, Tokyo, Japan).
Measured: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Change in plasma dopamine (nmol/L) concentrations
Dopamine concentrations (nmol/L) were measured using a kit for dopamine enzyme-linked immunosorbent assay (ELISA) (IBL, Hamburg, Germany).
Measured: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Change in plasma prolactin (ng/mL) concentrations
Prolactin levels (ng/mL) were measured using a kit for prolactin ELISA (IBL) and Gemini analyzer (Stratec Biomedical GmbH, Germany).
Measured: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Change in subjective rating of perceived exertion
Perceived exertion was assessed using the Borg scale, ranging from 6 (no exertion) to 20 (maximum exertion).
Measured: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Change in muscle activity (mV)
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.
Measured: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Change in muscle activity (Hz)
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.
Measured: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Change in voluntary torque (Nm)
Isometric and isokinetic voluntary torques (in Nm) of the quadriceps muscles were measured using an isokinetic dynamometer (Biodex Medical Systems, USA).
Measured: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Change in involuntary torque (Nm)
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.
Measured: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Change in muscle contraction and relaxation (ms)
The contraction and half-relaxation time (in ms) were measured in 100Hz stimulated contractions.
Measured: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Change in central activation ratio (percent)
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.
Measured: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Change in constant error
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 (±).
Measured: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Change in absolute error
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 (±).
Measured: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Secondary outcomes (1)
Height (m)
Height (in m) was measured using a Harpenden anthropometer set (Holtain Ltd, UK)
Measured: Every time in all conditions at the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start4 Feb 2014
- Primary completion1 Mar 2016
- Study completion8 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian Sports University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gintarė Daukšaitė, Principal investigator, Lithuanian Sports University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370403
- Sponsor's protocol ID
- LithuanianSportsU-21
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06370403
- Acronym / sponsor ID
- LithuanianSportsU-21
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Cooling, Heating, Fatigue, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lithuanian Sports UniversityUniversity, hospital or other
- Study start
- 4 Feb 2014 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 8 Jan 2017 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cooling of the head and neck in multiple sclerosis and healthy subjects | Experimental | Other: Cooling of the head and neckMultiple 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). |
| Heating of the head and neck in multiple sclerosis and healthy subjects | Experimental | Other: Heating of the head and neckMultiple 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). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cooling of the head and neckCooling of the head and neck at 18°C next to the head and neck skin in multiple sclerosis and healthy subjects | Other | Cooling of the head and neck in multiple sclerosis and healthy subjects |
| Heating of the head and neckHeating of the head and neck at 43 ± 1°C next to the head and neck skin in multiple sclerosis | Other | Heating of the head and neck in multiple sclerosis and healthy subjects |
Primary outcome
Body weight (kg)
Time frame: Every time in all conditions at the baseline
Body weight (kg) was evaluated using Tanita Body Composition Analyzer (Japan).
Body fat (%)
Time frame: Every time in all conditions at the baseline
Body fat (%) was assessed using Tanita Body Composition Analyzer (Japan).
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).
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.
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.
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).
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).
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).
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).
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.
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.
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).
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.
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.
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.
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 (±).
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 (±).
1 secondary outcome
Height (m)
Time frame: Every time in all conditions at the baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gintarė Daukšaitė principal investigator
Lithuanian Sports University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooling of the head and neck and Heating of the head and neck in people with Multiple Sclerosis, run by Lithuanian Sports University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (kg) (time frame: Every time in all conditions at the baseline). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.