Clinical trial NCT03380676: Study of Speech Disorders , Voice and Swallowing in Primary Dystonia Oromandibular
Official title: Study of Speech Disorders , Voice and Swallowing in Primary Dystonia Oromandibular
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dystonia, Primary
Dysarthria
Dysphonia
Dysphagia
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 28
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Oromandibular dystonia group
* Healthy controls group

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.


Eligibility 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

Primary outcomes:
measure: French scale "Batterie d'Evaluation Clinique de la Dysarthrie" (Clinical Evaluation of Dysarthria) phonetic analysis.
timeFrame: 10 minutes at baseline
Secondary outcomes:
measure: French software "Logiciel d'Evaluation Vocale Assistée" (Computer-Assisted Voice Assessment): maximum phonation time
timeFrame: 1 minute at baseline
measure: French software "Logiciel d'Evaluation Vocale Assistée" (Computer-Assisted Voice Assessment): frequency variations
timeFrame: 1 minute at baseline
measure: French software "Logiciel d'Evaluation Vocale Assistée" (Computer-Assisted Voice Assessment): number of pauses.
timeFrame: 1 minute at baseline
measure: French software "Logiciel d'Evaluation Vocale Assistée" (Computer-Assisted Voice Assessment): total lecture time.
timeFrame: 1 minute at baseline
measure: French software "Logiciel d'Evaluation Vocale Assistée" (Computer-Assisted Voice Assessment): pauses duration
timeFrame: 1 minute at baseline
measure: French software "Logiciel d'Evaluation Vocale Assistée" (Computer-Assisted Voice Assessment): fundamental frequency
timeFrame: 1 minute at baseline
measure: French software "Logiciel d'Evaluation Vocale Assistée" (Computer-Assisted Voice Assessment): repetitions.
timeFrame: 2 minutes at baseline
measure: French software "Logiciel d'Evaluation Vocale Assistée" (Computer-Assisted Voice Assessment): mean vocal intensity
timeFrame: 1 minute at baseline
measure: Voice handicap index
timeFrame: 10 minutes at baseline
measure: Tohara swallowing test
timeFrame: 5 minutes at baseline
measure: Deglutition Handicap Index
timeFrame: 10 minutes at baseline
measure: Oromandibular dystonia questionnaire
timeFrame: 10 minutes at baseline
measure: Grade Rough Breathy Asthenic Strained scale
timeFrame: 5 minutes at baseline
measure: French scale "Batterie d'Evaluation Clinique de la Dysarthrie" (Clinical Evaluation of Dysarthria) phonetics characteristics
timeFrame: 5 minutes at baseline
measure: French scale "Batterie d'Evaluation Clinique de la Dysarthrie" (Clinical Evaluation of Dysarthria) perceptive analysis.
timeFrame: 5 minutes at baseline
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHRU
Study officials:
affiliation: University Hospital, Lille
name: Alexandre Kreisler, MD
role: PRINCIPAL_INVESTIGATOR
References: