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

December 20, 2017 updated by: University Hospital, Lille
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • Hôpital Roger Salengro, CHRU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • Oromandibular dystonia group
  • Healthy controls group

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
10 minutes at baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 minute at baseline
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.
1 minute at baseline
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.
1 minute at baseline
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.
1 minute at baseline
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.
1 minute at baseline
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
1 minute at baseline
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.
2 minutes at baseline
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
1 minute at baseline
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 minutes at baseline
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
5 minutes at baseline
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)
10 minutes at baseline
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)
10 minutes at baseline
Grade Rough Breathy Asthenic Strained scale
Time Frame: 5 minutes at baseline
To describe dysphonia: from 0 (normal) to 3 (severe)
5 minutes at baseline
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).
5 minutes at baseline
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)
5 minutes at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Alexandre Kreisler, MD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

November 8, 2017

First Submitted That Met QC Criteria

December 20, 2017

First Posted (ACTUAL)

December 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 21, 2017

Last Update Submitted That Met QC Criteria

December 20, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013_34
  • 2013-A01299-36 (OTHER: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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