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

NCT03380676 | Completed DMC

• 2 other identifiers: 2013_342013-A01299-36
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Dystonia, Primary; Dysarthria; Dysphonia; Dysphagia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• French software "Logiciel d'Evaluation Vocale Assistée" (Computer-Assisted Voice Assessment): maximum phonation time

  1 minute at baseline

• French software "Logiciel d'Evaluation Vocale Assistée" (Computer-Assisted Voice Assessment): frequency variations

  1 minute at baseline

• French software "Logiciel d'Evaluation Vocale Assistée" (Computer-Assisted Voice Assessment): number of pauses.

  1 minute at baseline

• French software "Logiciel d'Evaluation Vocale Assistée" (Computer-Assisted Voice Assessment): total lecture time.

  1 minute at baseline

• French software "Logiciel d'Evaluation Vocale Assistée" (Computer-Assisted Voice Assessment): pauses duration

  1 minute at baseline

Study Arms (2)

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

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Oromandibular dystonia group * Healthy controls group

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Roger Salengro, CHRU

Lille, France

Location

MeSH Terms

Conditions

Dystonic Disorders; Dysarthria; Dysphonia; Deglutition Disorders

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Articulation Disorders; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases

Study Officials

• Alexandre Kreisler, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: December 21, 2017
• Study Start: February 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 21, 2017

Record last verified: 2017-12

Locations

FR (1)