NCT03487705

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 4, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2021

Completed
Last Updated

November 18, 2021

Status Verified

September 1, 2021

Enrollment Period

3 years

First QC Date

February 1, 2018

Last Update Submit

November 10, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • characteristics of TE

    échelle Fahn-Marin- Tolosa FMT

    1 day

Secondary Outcomes (1)

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

    1 day

Study Arms (1)

child essential tremor

OTHER

electromyogram with accelerometer

Other: electromyographic essential tremor

Interventions

* 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.

child essential tremor

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Subject whose age is between 3 and 18 years
  • Subject affiliated to a social security scheme
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Gui de Chauliac

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Agathe ROUBERTIE, Pr

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2018

First Posted

April 4, 2018

Study Start

July 1, 2018

Primary Completion

July 2, 2021

Study Completion

July 2, 2021

Last Updated

November 18, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations