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Completed

NCT Number: NCT03380676

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

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.

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Key information

Conditions

Dystonia, Primary Articulation Disorders Central Nervous System Diseases Communication Disorders Deglutition Disorders Digestive System Diseases Dysarthria Dysphagia Dysphonia Dystonic Disorders Esophageal Diseases Gastrointestinal Diseases Language Disorders Laryngeal Diseases Movement Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Respiratory Tract Diseases Signs and Symptoms Speech Disorders Voice Disorders

Age range

8 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Roger Salengro, CHRU

Lille, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Primary outcomes

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

    Time frame: 10 minutes at baseline

    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).

Secondary outcomes

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

    Time frame: 1 minute at baseline

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

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

    Time frame: 1 minute at baseline

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

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

    Time frame: 1 minute at baseline

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

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

    Time frame: 1 minute at baseline

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

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

    Time frame: 1 minute at baseline

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

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

    Time frame: 1 minute at baseline

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

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

    Time frame: 2 minutes at baseline

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

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

    Time frame: 1 minute at baseline

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

  9. Voice handicap index

    Time frame: 10 minutes at baseline

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

  10. Tohara swallowing test

    Time frame: 5 minutes at baseline

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

  11. Deglutition Handicap Index

    Time frame: 10 minutes at baseline

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

  12. Oromandibular dystonia questionnaire

    Time frame: 10 minutes at baseline

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

  13. Grade Rough Breathy Asthenic Strained scale

    Time frame: 5 minutes at baseline

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

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

    Time frame: 5 minutes at baseline

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

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

    Time frame: 5 minutes at baseline

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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: DOM

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 21, 2017
Registry last updated
Dec 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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