Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-29 @ 5:46 PM
Study NCT ID:
NCT06370403
Status:
COMPLETED
Last Update Posted:
2024-04-19
First Post:
2024-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Head and Neck Cooling and Heating on Fatigue in Multiple Sclerosis and Healthy Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The researchers who analyzed the venous blood samples were blinded.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2017-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2024-04-11', 'studyFirstSubmitQcDate': '2024-04-14', 'lastUpdatePostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight (kg)', 'timeFrame': 'Every time in all conditions at the baseline', 'description': 'Body weight (kg) was evaluated using Tanita Body Composition Analyzer (Japan).'}, {'measure': 'Body fat (%)', 'timeFrame': 'Every time in all conditions at the baseline', 'description': 'Body fat (%) was assessed using Tanita Body Composition Analyzer (Japan).'}, {'measure': 'Body free fat mass (kg)', 'timeFrame': 'Every time in all conditions at the baseline', 'description': 'Body free fat mass (kg) was evaluated using Tanita Body Composition Analyzer (Japan).'}, {'measure': 'Body mass index (kg/m2)', 'timeFrame': 'Every time in all conditions at the baseline', 'description': 'The body mass index (in kg/m2) was defined as the body mass divided by the square of the body height.'}, {'measure': 'Change in muscle temperature (°C)', 'timeFrame': 'Baseline, up to 60 minutes, up to 120 minutes, after 180minutes', 'description': '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.'}, {'measure': 'Change in plasma cortisol (nmol/L) concentrations', 'timeFrame': 'Baseline, up to 60 minutes, up to 120 minutes, after 180minutes', 'description': 'Plasma cortisol concentrations (nmol/L) were measured using an AIA-2000 automated enzyme immunoassay analyser (Tosoh Corp, Tokyo, Japan).'}, {'measure': 'Change in plasma dopamine (nmol/L) concentrations', 'timeFrame': 'Baseline, up to 60 minutes, up to 120 minutes, after 180minutes', 'description': 'Dopamine concentrations (nmol/L) were measured using a kit for dopamine enzyme-linked immunosorbent assay (ELISA) (IBL, Hamburg, Germany).'}, {'measure': 'Change in plasma prolactin (ng/mL) concentrations', 'timeFrame': 'Baseline, up to 60 minutes, up to 120 minutes, after 180minutes', 'description': 'Prolactin levels (ng/mL) were measured using a kit for prolactin ELISA (IBL) and Gemini analyzer (Stratec Biomedical GmbH, Germany).'}, {'measure': 'Change in subjective rating of perceived exertion', 'timeFrame': 'Baseline, up to 60 minutes, up to 120 minutes, after 180minutes', 'description': 'Perceived exertion was assessed using the Borg scale, ranging from 6 (no exertion) to 20 (maximum exertion).'}, {'measure': 'Change in muscle activity (mV)', 'timeFrame': 'Baseline, up to 60 minutes, up to 120 minutes, after 180minutes', 'description': '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.'}, {'measure': 'Change in muscle activity (Hz)', 'timeFrame': 'Baseline, up to 60 minutes, up to 120 minutes, after 180minutes', 'description': '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.'}, {'measure': 'Change in voluntary torque (Nm)', 'timeFrame': 'Baseline, up to 60 minutes, up to 120 minutes, after 180minutes', 'description': 'Isometric and isokinetic voluntary torques (in Nm) of the quadriceps muscles were measured using an isokinetic dynamometer (Biodex Medical Systems, USA).'}, {'measure': 'Change in involuntary torque (Nm)', 'timeFrame': 'Baseline, up to 60 minutes, up to 120 minutes, after 180minutes', 'description': '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.'}, {'measure': 'Change in muscle contraction and relaxation (ms)', 'timeFrame': 'Baseline, up to 60 minutes, up to 120 minutes, after 180minutes', 'description': 'The contraction and half-relaxation time (in ms) were measured in 100Hz stimulated contractions.'}, {'measure': 'Change in central activation ratio (percent)', 'timeFrame': 'Baseline, up to 60 minutes, up to 120 minutes, after 180minutes', 'description': '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.'}, {'measure': 'Change in constant error', 'timeFrame': 'Baseline, up to 60 minutes, up to 120 minutes, after 180minutes', 'description': '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 (±).'}, {'measure': 'Change in absolute error', 'timeFrame': 'Baseline, up to 60 minutes, up to 120 minutes, after 180minutes', 'description': '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 (±).'}], 'secondaryOutcomes': [{'measure': 'Height (m)', 'timeFrame': 'Every time in all conditions at the baseline', 'description': 'Height (in m) was measured using a Harpenden anthropometer set (Holtain Ltd, UK)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple sclerosis', 'Cooling', 'Heating', 'Fatigue', 'Exercise'], 'conditions': ['Multiple Sclerosis']}, '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Relapsing-remitting multiple sclerosis disease course according to McDonald criteria\n* Expanded Disability Status Scale less than 4 points and Fatigue Severity Scale score greater than 5 points in participants with multiple sclerosis\n* Males\n* Age between 18 and 45 years\n* Sufficient tolerance to electrical stimulation\n\nExclusion Criteria:\n\n* Physical limitations that would impair the ability to perform neuromuscular testing\n* Mental disorders, such as depression or anxiety, due to their recognized association with fatigue\n* Involvement in temperature manipulation program for ≥ 3 months\n* Attending any excessive physical exercise or sports programs\n* With blood/needle phobia'}, 'identificationModule': {'nctId': 'NCT06370403', 'briefTitle': 'Effects of Head and Neck Cooling and Heating on Fatigue in Multiple Sclerosis and Healthy Men', 'organization': {'class': 'OTHER', 'fullName': 'Lithuanian Sports University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'LithuanianSportsU-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cooling of the head and neck in multiple sclerosis and healthy subjects', 'description': '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).', 'interventionNames': ['Other: Cooling of the head and neck']}, {'type': 'EXPERIMENTAL', 'label': 'Heating of the head and neck in multiple sclerosis and healthy subjects', 'description': '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).', 'interventionNames': ['Other: Heating of the head and neck']}], 'interventions': [{'name': 'Cooling of the head and neck', 'type': 'OTHER', 'description': 'Cooling of the head and neck at 18°C next to the head and neck skin in multiple sclerosis and healthy subjects', 'armGroupLabels': ['Cooling of the head and neck in multiple sclerosis and healthy subjects']}, {'name': 'Heating of the head and neck', 'type': 'OTHER', 'description': 'Heating of the head and neck at 43 ± 1°C next to the head and neck skin in multiple sclerosis', 'armGroupLabels': ['Heating of the head and neck in multiple sclerosis and healthy subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LT 44221', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Lithuanian Sports University', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}], 'overallOfficials': [{'name': 'Gintarė Daukšaitė', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lithuanian Sports University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lithuanian Sports University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}