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Examining the Spasmodic Dysphonia Diagnosis and Assessment Procedure (SD-DAP) for Measuring Symptom Change

NCT ID: NCT02061943

Last Updated: 2016-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-04-30

Brief Summary

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This is a study of patients with spasmodic dysphonia to determine how best to measure the severity of the disorder in patients. It addresses which characteristics of speech are the best indicator of whether or not a particular treatment has benefited a person with spasmodic dysphonia. We hope to recruit 20 participants each at 2 different centers. The evaluation for each participant will be done on a two visits, one just before and another several weeks after treatment.

Detailed Description

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This is a study of changes in voice and laryngeal function with treatment recorded using the Spasmodic Dysphonia Diagnosis and Assessment Procedure (SD-DAP). Persons with adductor spasmodic dysphonia will complete a questionnaire on the Voice Handicap Index (VHI) and ratings of speech effort as well as have their speech recorded and receive a nasolaryngoscopy examination prior to their usual treatment with botulinum toxin injection into the laryngeal muscles for their voice disorder. They will return for re-examination several weeks later after their injection and repeat each of the examinations. The purpose is to determine which items on the SD-DAP are sensitive to changes in the severity of their voice disorder. The items that show sensitivity would be those that would be useful for assessing voice outcomes in clinical trials. Some of the questions this study is trying to answer are

* What is the best way to measure the severity of spasmodic dysphonia?
* How does treatment of spasmodic dysphonia by botulinum toxin injection affect voice for communication in regular daily life in spasmodic dysphonia
* Is change in speaking effort related to the change in severity of spasmodic dysphonia with botulinum toxin injection?

Each participant in this study will be asked to do the following:

* Provide a copy of medical records and medical history relating to the diagnosis of spasmodic dysphonia.
* Have an examination by an otolaryngologist with a medical periscope inserted in the throat to view the voice box in action. The examination will be so it can be reviewed later by several different experts.
* Complete questionnaires regarding the severity of their disorder before and after receiving their usual treatment; an injection of botulinum toxin into the laryngeal muscles.
* Repeat a speech recording and laryngeal examination before and after treatment

Conditions

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Spasmodic Dysphonia Laryngeal Dystonia

Keywords

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Spasmodic dysphonia Laryngeal dystonia Dystonia Severity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* be clinically diagnosed with primary spasmodic dysphonia (laryngeal dystonia)
* be 18 years of age or older

Exclusion Criteria

* be diagnosed with secondary spasmodic dysphonia (laryngeal dystonia)
* be younger than 18 years of age
* unable to complete questionnaires
* not able to have a nasolaryngoscopy (examination of the voice box with a medical periscope)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Office of Rare Diseases (ORD)

NIH

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Hyder A. Jinnah, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christy Ludlow, PhD

Role: PRINCIPAL_INVESTIGATOR

James Madison University

Locations

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Emory University

Atlanta, Georgia, United States

Site Status

Washington University in St. Louis

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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U54NS065701

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00068259

Identifier Type: -

Identifier Source: org_study_id