Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT03487705
Status:
TERMINATED
Last Update Posted:
2021-11-18
First Post:
2018-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Essential Tremor in Children and Adolescent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020329', 'term': 'Essential Tremor'}], 'ancestors': [{'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'whyStopped': 'Halted Prematurely due to difficulties in inclusion.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-10', 'studyFirstSubmitDate': '2018-02-01', 'studyFirstSubmitQcDate': '2018-03-27', 'lastUpdatePostDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'characteristics of TE', 'timeFrame': '1 day', 'description': 'échelle Fahn-Marin- Tolosa FMT'}], 'secondaryOutcomes': [{'measure': 'determine the electrophysiological characteristics impact of TE functional questionnaire, an electromyogram with accelerometer.', 'timeFrame': '1 day', 'description': 'electromyogram with accelerometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Essential Tremor']}, 'descriptionModule': {'briefSummary': 'Essential tremor (TE) is the most common abnormal movement of the adult. His diagnosis is based on a bundle of clinical arguments (Movement Disorders Society, 1998). Well characterized in the adult, little data is available concerning child. The objective of this work is (1) to define the demographic and clinical characteristics of the TE of children and adolescents, (2) to determine the electrophysiological characteristics in the child, (3) evaluate the functional impact of TE, and assess the functional impact of TE, and assess the current management modalities of TE in children and adolescent.', 'detailedDescription': 'A multicenter, descriptive cross-sectional study will include children and adolescents whose diagnosis of TE has been retained by an abnormal movement specialist before the age of 18 years.\n\nEach child will benefit from an examination and a neurological and general clinical examination, a functional questionnaire, an electromyogram with accelerometer.\n\nWill be determined: demographic characteristics (age, sex and ethnicity), family history of essential tremor, age of onset of tremor, tremor characteristics (location, occurrence conditions, aggravating or precipitating factors, scalability); additional examinations carried out and the treatments proposed or taken by the child as well as the functional repercussions of TE in the child.\n\nPatients with tremor who meet the inclusion and exclusion criteria will be selected retrospectively or prospectively from the active queue of patients at each center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject whose age is between 3 and 18 years\n* Subject affiliated to a social security scheme\n* Parents or subjects who have been informed of the course and consequences of the study by an investigator and who have signed the informed consent form for prospective inclusion or who have given their non-opposition for retrospective inclusion.\n* Diagnosis of essential tremor established according to the diagnostic criteria of the Movement Disorders Society (1998), by a neuropediatrician or a neurologist, specialist in abnormal movements. The diagnosis is based on the presence of the following criteria: bilateral action tremor of the hands and forearms, absence of other neurological signs.\n* Availability of an electromyogram for retrospective inclusions.\n\nExclusion Criteria:\n\n* Abnormal neurological examination outside tremor\n* Family history or personal dysthyroidism\n* Existence of a global psychomotor or motor developmental delay\n* Taking medication that may induce tremor\n* known poisoning by heavy metals, bismuth, mercury, methyl bromide\n* Severe appearance of the tremor\n* Tremor suggestive of a psychogenic origin\n* Abnormal or non-existent brain MRI if family case'}, 'identificationModule': {'nctId': 'NCT03487705', 'briefTitle': 'Essential Tremor in Children and Adolescent', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Clinical and Electrophysiological Characterization of Essential Tremor in Children and Adolescents', 'orgStudyIdInfo': {'id': 'UF9770'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'child essential tremor', 'description': 'electromyogram with accelerometer', 'interventionNames': ['Other: electromyographic essential tremor']}], 'interventions': [{'name': 'electromyographic essential tremor', 'type': 'OTHER', 'description': '* Making a recording electromyographic recording of the essential tremors in each child included at prospective.\n* Collect an electromyographic recording of essential tremors already made in each child included at retrospective.', 'armGroupLabels': ['child essential tremor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU Gui de Chauliac', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Agathe ROUBERTIE, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}