- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03487705
Essential Tremor in Children and Adolescent
Clinical and Electrophysiological Characterization of Essential Tremor in Children and Adolescents
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Montpellier, France, 34295
- CHU Gui de Chauliac
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: child essential tremor
electromyogram with accelerometer
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
characteristics of TE
Time Frame: 1 day
|
échelle Fahn-Marin- Tolosa FMT
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
determine the electrophysiological characteristics impact of TE functional questionnaire, an electromyogram with accelerometer.
Time Frame: 1 day
|
electromyogram with accelerometer
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Agathe ROUBERTIE, Pr, University Hospital, Montpellier
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UF9770
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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