Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT06573918
Status:
COMPLETED
Last Update Posted:
2024-08-27
First Post:
2024-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EMG-Assessed Paratonia: A New Approach to Response Inhibition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-23', 'studyFirstSubmitDate': '2024-08-23', 'studyFirstSubmitQcDate': '2024-08-23', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuromuscular excitation of the Biceps Brachii (paratonia assessed by EMG) during passive elbow flexion and extension', 'timeFrame': 'Throughout the duration of the evaluation, which lasts about 120 seconds', 'description': 'Amplitude of electromyography value (Root Mean Square in microvolt) measured for Biceps Brachii muscle'}, {'measure': 'Neuromuscular excitation of the Triceps Brachii (paratonia assessed by EMG) during passive elbow flexion and extension', 'timeFrame': 'Throughout the duration of the evaluation, which lasts about 120 seconds', 'description': 'Amplitude of electromyography value (Root Mean Square in microvolt) measured for Triceps Brachii muscle'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Electromyography Physical activity', 'Motor inhibition', 'Frontal circuits', 'Sport-specific'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Paratonia is the inability to relax muscles during the assessment of muscle tone in the absence of spasticity and parkinsonian rigidity. It can be evaluated qualitatively using clinical scales and objectively through surface electromyography (EMG-assessed paratonia). It is widely accepted that paratonia represents a manifestation of impaired motor response inhibition due to frontal lobe dysfunction.\n\nTraditionally, motor response inhibition has been assessed using experimental protocols such as go/no-go and stop-signal tasks. Research has shown that athletes, particularly those engaged in open-skill sports, demonstrate superior motor response inhibition compared to sedentary individuals. Even amateur athletes exhibit better motor response inhibition than sedentary individuals, though to a lesser extent than professional athletes.\n\nGiven that the etiology of paratonia involves a defect in motor response inhibition, it is hypothesized that EMG-assessed paratonia could become a novel approach for evaluating motor response inhibition. The present study was designed to validate this hypothesis. Specifically, we first tested whether EMG-assessed paratonia in healthy subjects can reveal a well-known aspect of motor response inhibition, namely its correlation with the level of physical activity.', 'detailedDescription': 'EMG-assessed paratonia was analyzed and compared to assess motor response efficiency in three groups of healthy young adults with different levels of physical activity: professional athletes engaged in closed and open skills sports, amateurs, and sedentary individuals. To analyze EMG-assessed paratonia, two surface electrodes were attached to the biceps and triceps brachii muscles during passive flexion-extension movements of the elbow while the participant remained in a state of maximum relaxation. Any EMG activity detected during these movements was attributed to an inability to relax, thereby reflecting their degree of paratonia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSedentary Individuals: Defined as those engaging in less than 16.67 metabolic equivalent of task (MET) hours per week.\n\nAmateur Athletes: Defined as individuals who engage in 16.67 to 25 MET hours per week.\n\nProfessional Athletes: Defined as individuals who engage in more than 25 MET hours per week.\n\nExclusion Criteria:\n\nPresence of any pathology or pain in the flexor or extensor muscles of the arm. Use of muscle stimulants, relaxants, steroids, tobacco, alcohol, or any other drugs.'}, 'identificationModule': {'nctId': 'NCT06573918', 'briefTitle': 'EMG-Assessed Paratonia: A New Approach to Response Inhibition', 'organization': {'class': 'OTHER', 'fullName': 'Universita degli Studi di Genova'}, 'officialTitle': 'EMG-Assessed Paratonia: A Novel Approach to Investigating Motor Response Inhibition in Healthy Subjects', 'orgStudyIdInfo': {'id': 'EMG-DINOGMI-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EMG-assessed paratonia group', 'description': "The study evaluated EMG-assessed paratonia to measure motor response efficiency across three groups of healthy young adults with varying physical activity levels: professional athletes (in both open and closed skills sports), amateurs, and sedentary individuals. Surface electrodes were placed on the biceps and triceps brachii muscles during passive elbow movements while participants remained relaxed. EMG activity detected during these movements was used to quantify the level of paratonia, indicating the participants' ability to relax their muscles.", 'interventionNames': ['Diagnostic Test: EMG-based assessment of paratonia']}], 'interventions': [{'name': 'EMG-based assessment of paratonia', 'type': 'DIAGNOSTIC_TEST', 'description': 'EMG-assessed paratonia was analyzed and compared to assess motor response efficiency in three groups of healthy young adults with different levels of physical activity: professional athletes engaged in closed and open skills sports, amateurs, and sedentary individuals. To analyze EMG-assessed paratonia, two surface electrodes were attached to the biceps and triceps brachii muscles during passive flexion-extension movements of the elbow while the participant remained in a state of maximum relaxation. Any EMG activity detected during these movements was attributed to an inability to relax, thereby reflecting their degree of paratonia.', 'armGroupLabels': ['EMG-assessed paratonia group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16122', 'city': 'Genova', 'country': 'Italy', 'facility': 'Università degli Studi di Genova', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universita degli Studi di Genova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigatior', 'investigatorFullName': 'Luca Puce', 'investigatorAffiliation': 'Universita degli Studi di Genova'}}}}