Essential Tremor in Children and Adolescent
Primary Purpose
Essential Tremor
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
electromyographic essential tremor
Sponsored by
About this trial
This is an interventional other trial for Essential Tremor
Eligibility Criteria
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
Sites / Locations
- CHU Gui de Chauliac
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
child essential tremor
Arm Description
electromyogram with accelerometer
Outcomes
Primary Outcome Measures
characteristics of TE
échelle Fahn-Marin- Tolosa FMT
Secondary Outcome Measures
determine the electrophysiological characteristics impact of TE functional questionnaire, an electromyogram with accelerometer.
electromyogram with accelerometer
Full Information
NCT ID
NCT03487705
First Posted
February 1, 2018
Last Updated
November 10, 2021
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT03487705
Brief Title
Essential Tremor in Children and Adolescent
Official Title
Clinical and Electrophysiological Characterization of Essential Tremor in Children and Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Halted Prematurely due to difficulties in inclusion.
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
July 2, 2021 (Actual)
Study Completion Date
July 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
child essential tremor
Arm Type
Other
Arm Description
electromyogram with accelerometer
Intervention Type
Other
Intervention Name(s)
electromyographic essential tremor
Intervention Description
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.
Primary Outcome Measure Information:
Title
characteristics of TE
Description
échelle Fahn-Marin- Tolosa FMT
Time Frame
1 day
Secondary Outcome Measure Information:
Title
determine the electrophysiological characteristics impact of TE functional questionnaire, an electromyogram with accelerometer.
Description
electromyogram with accelerometer
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agathe ROUBERTIE, Pr
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Gui de Chauliac
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Essential Tremor in Children and Adolescent
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