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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

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.

02

Conditions studied

  • Dystonia, Primary
  • Dysarthria
  • Dysphonia
  • Dysphagia
03

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

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
04

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

05

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

06

Study locations

1 site
  • Hôpital Roger Salengro, CHRU
    Lille, France
07

Registry details

Key details

Study ID
NCT03380676
Lead sponsor
University Hospital, Lille
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
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