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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Lille

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 21, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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