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CompletedNCT03380676DOMUpdated Dec 21, 2017

Study of Speech Disorders , Voice and Swallowing in Primary Dystonia Oromandibular

An observational study in Dystonia, Primary, Dysarthria and Dysphonia, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 8 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-21.

Sponsored by University Hospital, Lille · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
28
Ages
8 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies in Dystonic Disorders with a site in France — 2 open to participants now, 2 under way, none of them phase 3. Dystonic Disorders · France.

Started
2014
with 1 other
Observational
5 of 13
1 open now
Registered
7th of 13
by date
Lead sponsor
2 of 13
University Hospital, Lille

Among the 13 studies in Dystonic Disorders with a site in France, this one is one of 2 that started in 2014, is one of 5 observational ones, and was the 7th registered.

By phase

13 studies; the count open now beside each. This study's row is marked.

No phase8 · 1 open
Observationalthis study5 · 1 open

By the year they started

First in 2014; this study’s year is marked. 2 started in 2014.

Size and results

Median enrollment 40 across the 8 interventional studies, 28 across the 5 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.

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02

Study summary

To better define the clinical characteristics of oromandibular dystonia, we aimed to study voice, speech and swallowing disorders in idiopathic oromandibular We planned to include consecutive patients followed in Lille Movement disorders department for idiopathic oromandibular dystonia and matched, healthy control subjects. Voice and speech disorders had to be assessed with the phonetic analysis, perceptive analysis and motor examination modules of the "Batterie d'Evaluation Clinique de la Dysarthrie" (Clinical Evaluation of Dysarthria), the Grade, Rough, Breathy, Asthenic, Strained scale, and a computer recording. Activities of daily living had to be assessed with the Oromandibular Dystonia Questionnaire, the Voice Handicap Index and the Deglutition Handicap Index.

03

Conditions studied

  • Dystonia, Primary
  • Dysarthria
  • Dysphonia
  • Dysphagia
04

Who can participate

Ages eligible
8 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

  • Oromandibular dystonia group
  • Healthy controls group

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Both groups: Man or woman Age > 18 years French social security French speaking: fluent
  • Oromandibular dystonia group: Idiopathic oromandibular dystonia (focal or associated to other dystonic symptoms)
  • Healthy controls group: Same age +/- 2 years than a patient from the oromandibular dystonia group Normal clinical examination

Exclusion criteria

Exclusion Criteria:

  • Both groups: Any pathology making the orthophonic evaluation difficult Property protection regime Deprivation of liberty -Oromandibular dystonia group: Abnormal neurological examination, except dystonic features
  • Healthy controls group: History of brain lesion Abnormal neurological examination Swallowing difficulties
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
28 participants (actual)
Patient registry
No

Groups and cohorts

  • Oromandibular dystonia group

    Patients with idiopathic oromandibular dystonia, either focal or associated to other dystonic features including generalized dystonia

  • Healthy subjects

    Healthy subjects (normal neurological examination), each being age-matched to a subjet of the oromandibular dystonia group

06

What researchers measure

Primary outcomes

  1. French scale "Batterie d'Evaluation Clinique de la Dysarthrie" (Clinical Evaluation of Dysarthria) phonetic analysis.

    To describe the clinical characteristics of dysarthria in idiopathic oromandibular dystonia. Composite score (min=best=0; max=worst=151) including three subscales: phonetic production (min=worst=0; max=best=33); simple words (min=worst=0; max=best=88); complex words (min=wost=0; max=best=30).

    Time frame: 10 minutes at baseline

Secondary outcomes

  1. French software "Logiciel d'Evaluation Vocale Assistée" (Computer-Assisted Voice Assessment): maximum phonation time

    To describe the clinical characteristics of voice impairment in idiopathic oromandibular dystonia. Maximum phonation time was measured in seconds.

    Time frame: 1 minute at baseline

  2. French software "Logiciel d'Evaluation Vocale Assistée" (Computer-Assisted Voice Assessment): frequency variations

    To describe the clinical characteristics of voice impairment in idiopathic oromandibular dystonia. Frequency variations were measured in Hz.

    Time frame: 1 minute at baseline

  3. French software "Logiciel d'Evaluation Vocale Assistée" (Computer-Assisted Voice Assessment): number of pauses.

    To describe the clinical characteristics of voice impairment in idiopathic oromandibular dystonia. The number of pauses was counted.

    Time frame: 1 minute at baseline

  4. French software "Logiciel d'Evaluation Vocale Assistée" (Computer-Assisted Voice Assessment): total lecture time.

    To describe the clinical characteristics of voice impairment in idiopathic oromandibular dystonia. Total lecture time was measured in seconds.

    Time frame: 1 minute at baseline

  5. French software "Logiciel d'Evaluation Vocale Assistée" (Computer-Assisted Voice Assessment): pauses duration

    To describe the clinical characteristics of voice impairment in idiopathic oromandibular dystonia. Pauses duration was measured in seconds.

    Time frame: 1 minute at baseline

  6. French software "Logiciel d'Evaluation Vocale Assistée" (Computer-Assisted Voice Assessment): fundamental frequency

    To describe the clinical characteristics of voice impairment in idiopathic oromandibular dystonia. Fundamental frequency was measured in Hz

    Time frame: 1 minute at baseline

  7. French software "Logiciel d'Evaluation Vocale Assistée" (Computer-Assisted Voice Assessment): repetitions.

    To describe the clinical characteristics of voice impairment in idiopathic oromandibular dystonia. Repetitions were measured in seconds.

    Time frame: 2 minutes at baseline

  8. French software "Logiciel d'Evaluation Vocale Assistée" (Computer-Assisted Voice Assessment): mean vocal intensity

    To describe the clinical characteristics of voice impairment in idiopathic oromandibular dystonia. Mean vocal intensity was measured in dB

    Time frame: 1 minute at baseline

  9. Voice handicap index

    To describe impairment of daily living activities in idiopathic oromandibular (min=best=0; max=worst=120)

    Time frame: 10 minutes at baseline

  10. Tohara swallowing test

    To describe the clinical characteristics of swallowing difficulties in idiopathic oromandibular dystonia. Min=best=0; max=worst=4

    Time frame: 5 minutes at baseline

  11. Deglutition Handicap Index

    To describe impairment of daily living activities in idiopathic oromandibular dystonia. Qualitative: 30 questions (possible answers: never; almost never; sometimes; often; always)

    Time frame: 10 minutes at baseline

  12. Oromandibular dystonia questionnaire

    To describe impairment of daily living activities in idiopathic oromandibular dystonia. Qualitative: 25 questions (possible answers: never; almost never; sometimes; often; always)

    Time frame: 10 minutes at baseline

  13. Grade Rough Breathy Asthenic Strained scale

    To describe dysphonia: from 0 (normal) to 3 (severe)

    Time frame: 5 minutes at baseline

  14. French scale "Batterie d'Evaluation Clinique de la Dysarthrie" (Clinical Evaluation of Dysarthria) phonetics characteristics

    Phonetic characteristics of voice: nine items, each quoted from A (normal) to E (strongly abnormal).

    Time frame: 5 minutes at baseline

  15. French scale "Batterie d'Evaluation Clinique de la Dysarthrie" (Clinical Evaluation of Dysarthria) perceptive analysis.

    To describe the clinical characteristics of dysarthria in idiopathic oromandibular dystonia. Perceptive score (min=best=0; max=worst=20)

    Time frame: 5 minutes at baseline

07

Study locations

1 site
  • Hôpital Roger Salengro, CHRU
    Lille, France
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2014, a primary completion of May 2014 and a completion of Jun 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 8, 2017
First posted
Dec 21, 2017
Start
Feb 2014
Primary completionActual
May 2014
CompletionActual
Jun 2014
Last update
Dec 21, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03380676
Responsible party
Sponsor
First posted
Dec 21, 2017
Start date
Feb 2014
Primary completion
May 2014
Completion
Jun 2014
Last update
Dec 21, 2017

Study contacts

Alexandre Kreisler, MD
principal investigator · University Hospital, Lille

Oversight

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

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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