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

Dysphagia Clinical Trial

— DOM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03380676
• Other study ID #: 2013_34
• Secondary ID: 2013-A01299-36
• Status: Completed
• Phase: N/A
• First received: November 8, 2017
• Last updated: December 20, 2017
• Start date: February 2014
• Est. completion date: June 2014

Study information

• Verified date: December 2017
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dysarthria
• Dysphagia
• Dysphonia
• Dystonia
• Dystonia, Primary
• Dystonic Disorders
• Speech Disorders

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHRU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	10 minutes at baseline
Secondary	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.	1 minute at baseline
Secondary	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.	1 minute at baseline
Secondary	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.	1 minute at baseline
Secondary	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.	1 minute at baseline
Secondary	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.	1 minute at baseline
Secondary	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	1 minute at baseline
Secondary	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.	2 minutes at baseline
Secondary	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	1 minute at baseline
Secondary	Voice handicap index	To describe impairment of daily living activities in idiopathic oromandibular (min=best=0; max=worst=120)	10 minutes at baseline
Secondary	Tohara swallowing test	To describe the clinical characteristics of swallowing difficulties in idiopathic oromandibular dystonia. Min=best=0; max=worst=4	5 minutes at baseline
Secondary	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)	10 minutes at baseline
Secondary	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)	10 minutes at baseline
Secondary	Grade Rough Breathy Asthenic Strained scale	To describe dysphonia: from 0 (normal) to 3 (severe)	5 minutes at baseline
Secondary	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).	5 minutes at baseline
Secondary	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)	5 minutes at baseline