NCT02061943

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2015

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2014

Completed
1.6 years until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 30, 2016

Status Verified

May 1, 2016

Enrollment Period

6 months

First QC Date

February 11, 2014

Last Update Submit

May 27, 2016

Conditions

Spasmodic DysphoniaLaryngeal Dystonia

Keywords

Spasmodic dysphoniaLaryngeal dystoniaDystoniaSeverity

Outcome Measures

Primary Outcomes (1)

  • SD-DAP

    Identify items within the SD-DAP that are sensitive to symptom reduction when participants with spasmodic dysphonia are treated with botulinum toxin.

    2-4 weeks

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with spasmodic dysphonia are eligible for this study.

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emory University

Atlanta, Georgia, 30322, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

DysphoniaDystonia

Condition Hierarchy (Ancestors)

Voice DisordersLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDyskinesias

Study Officials

  • Christy Ludlow, PhD

    James Madison University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 11, 2014

First Posted

February 13, 2014

Study Start

October 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 30, 2016

Record last verified: 2016-05

Locations

US(2)