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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03487705
Other study ID # UF9770
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date July 1, 2018
Est. completion date July 2, 2021

Study information

Verified date September 2021
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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. Each child will benefit from an examination and a neurological and general clinical examination, a functional questionnaire, an electromyogram with accelerometer. Will 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. Patients with tremor who meet the inclusion and exclusion criteria will be selected retrospectively or prospectively from the active queue of patients at each center.


Recruitment information / eligibility

Status Terminated
Enrollment 18
Est. completion date July 2, 2021
Est. primary completion date July 2, 2021
Accepts healthy volunteers No
Gender All
Age group 3 Years to 18 Years
Eligibility Inclusion Criteria: - Subject whose age is between 3 and 18 years - Subject affiliated to a social security scheme - 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. - 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. - Availability of an electromyogram for retrospective inclusions. Exclusion Criteria: - Abnormal neurological examination outside tremor - Family history or personal dysthyroidism - Existence of a global psychomotor or motor developmental delay - Taking medication that may induce tremor - known poisoning by heavy metals, bismuth, mercury, methyl bromide - Severe appearance of the tremor - Tremor suggestive of a psychogenic origin - Abnormal or non-existent brain MRI if family case

Study Design


Related Conditions & MeSH terms


Intervention

Other:
electromyographic essential tremor
Making a recording electromyographic recording of the essential tremors in each child included at prospective. Collect an electromyographic recording of essential tremors already made in each child included at retrospective.

Locations

Country Name City State
France CHU Gui de Chauliac Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary characteristics of TE échelle Fahn-Marin- Tolosa FMT 1 day
Secondary determine the electrophysiological characteristics impact of TE functional questionnaire, an electromyogram with accelerometer. electromyogram with accelerometer 1 day
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