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Trial record 11 of 330 for:    "Speech Disorders"

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

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ClinicalTrials.gov Identifier: NCT03380676
Recruitment Status : Completed
First Posted : December 21, 2017
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief 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.

Condition or disease
Dystonia, Primary Dysarthria Dysphonia Dysphagia

Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Study of Speech Disorders , Voice and Swallowing in Primary Dystonia Oromandibular
Study Start Date : February 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : June 2014


Group/Cohort
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



Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • Oromandibular dystonia group
  • Healthy controls group
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380676


Locations
France
Hôpital Roger Salengro, CHRU
Lille, France
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Alexandre Kreisler, MD University Hospital, Lille

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03380676     History of Changes
Other Study ID Numbers: 2013_34
2013-A01299-36 ( Other Identifier: ID-RCB number, ANSM )
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Speech Disorders
Dystonia
Dystonic Disorders
Dysphonia
Dysarthria
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Articulation Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations