Essential TremorNCT03487705
Essential Tremor in Children and Adolescent
A study testing electromyographic essential tremor in people with Essential Tremor, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Essential Tremor
- What is being tested?
- electromyographic essential tremor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2018to 2 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Electrophysiological Characterization of Essential Tremor in Children and Adolescents
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.
- Conditions
- Essential Tremor
- Being tested
- electromyographic essential tremor
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electromyographic essential tremorOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| child essential tremor | Other | electromyogram with accelerometer Receives: Other: electromyographic essential tremor |
What is being measured
The primary outcome is the main question the study is designed to answer.
characteristics of TE
échelle Fahn-Marin- Tolosa FMT
Measured: 1 day
Secondary outcomes (1)
determine the electrophysiological characteristics impact of TE functional questionnaire, an electromyogram with accelerometer.
electromyogram with accelerometer
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start1 Jul 2018
- Primary completion2 Jul 2021
- Study completion2 Jul 2021
Why it stopped: Halted Prematurely due to difficulties in inclusion.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agathe ROUBERTIE, Pr, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487705
- Sponsor's protocol ID
- UF9770
- Status last verified
- Sep 2021
- First submitted
- 1 Feb 2018
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Electrophysiological Characterization of Essential Tremor in Children and Adolescents
- ClinicalTrials.gov ID
- NCT03487705
- Acronym / sponsor ID
- UF9770
- Conditions
- Essential Tremor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Halted Prematurely due to difficulties in inclusion.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 2 Jul 2021 (actual)
- First posted
- 4 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| child essential tremor | Other | Other: electromyographic essential tremorelectromyogram with accelerometer |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electromyographic 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. | Other | child essential tremor |
Primary outcome
characteristics of TE
Time frame: 1 day
échelle Fahn-Marin- Tolosa FMT
1 secondary outcome
determine the electrophysiological characteristics impact of TE functional questionnaire, an electromyogram with accelerometer.
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Halted Prematurely due to difficulties in inclusion.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Essential Tremor
Active, not recruitingObservational study
Identifying Markers of Disease Subtypes and Disease Progression in the Syndrome of Essential Tremor
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Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Essential Tremor
Upper Limb Essential Tremor
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Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
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Phenotype/Genotype Correlations in Movement Disorders
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Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agathe ROUBERTIE, Pr principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electromyographic essential tremor in people with Essential Tremor, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Halted Prematurely due to difficulties in inclusion.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
characteristics of TE (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021.