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Essential Tremor in Children and Adolescent

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03487705
Recruitment Status : Recruiting
First Posted : April 4, 2018
Last Update Posted : July 8, 2019
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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.

Condition or disease Intervention/treatment Phase
Essential Tremor Other: electromyographic essential tremor Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Clinical and Electrophysiological Characterization of Essential Tremor in Children and Adolescents
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Arm Intervention/treatment
child essential tremor
electromyogram with accelerometer
Other: electromyographic essential tremor
Making a recording electromyographic essential tremor in each child

Primary Outcome Measures :
  1. characteristics of TE [ Time Frame: 1 day ]
    échelle Fahn-Marin- Tolosa FMT

Secondary Outcome Measures :
  1. determine the electrophysiological characteristics impact of TE functional questionnaire, an electromyogram with accelerometer. [ Time Frame: 1 day ]
    electromyogram with accelerometer

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 progress and consequences of the study by an investigator and have signed the informed consent form
  • 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03487705

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Contact: Agathe ROUBERTIE, Pr 04 67 33 01 82
Contact: Guillemette TACONNET DECKER

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CHU Gui de Chauliac Recruiting
Montpellier, France, 34295
Contact: Agathe ROUBERTIE, PU-PH    0467330182   
Sponsors and Collaborators
University Hospital, Montpellier
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Principal Investigator: Agathe ROUBERTIE, Pr University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier Identifier: NCT03487705     History of Changes
Other Study ID Numbers: UF9770
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Essential Tremor
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases