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TerminatedNCT03487705Updated Nov 18, 2021

Essential Tremor in Children and Adolescent

An interventional study of electromyographic essential tremor in Essential Tremor, sponsored by University Hospital, Montpellier. Terminated at 1 site in France. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2021-11-18.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Other

Why this study was terminated
Halted Prematurely due to difficulties in inclusion.
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
3 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Essential Tremor
03

Who can participate

Ages eligible
3 Years to 18 Years
Sexes eligible
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 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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Other
    child essential tremor

    electromyogram with accelerometer

    Other: electromyographic essential tremor

Interventions

  • Otherelectromyographic 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.

05

What researchers measure

Primary outcomes

  1. characteristics of TE

    échelle Fahn-Marin- Tolosa FMT

    Time frame: 1 day

Secondary outcomes

  1. determine the electrophysiological characteristics impact of TE functional questionnaire, an electromyogram with accelerometer.

    electromyogram with accelerometer

    Time frame: 1 day

06

Study locations

1 site
  • CHU Gui de Chauliac
    Montpellier, 34295, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03487705
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Apr 4, 2018
Start date
Jul 1, 2018
Primary completion
Jul 2, 2021
Completion
Jul 2, 2021
Last update
Nov 18, 2021

Study contacts

Agathe ROUBERTIE, Pr
principal investigator · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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