NCT00066911

Brief Summary

Some voice disorders are caused by uncontrolled muscle actions that affect the larynx or voice box. The purpose of this study is to understand 1) how the brain controls voice production; 2) how changes in sensation within the voice box affect brain control of the voice box; 3) how the central nervous system is affected when people have motor or sensory abnormalities that affect the voice box; and 4) whether patients with voice disorders differ from people without voice disorders in the way the brain controls the voice box. By better understanding these concepts, researchers hope to develop improved treatments for patients with voice disorders. Forty-five healthy adult volunteers and 90 patients with voice disorders will participate in this study. Participants must be between the ages of 20 and 70. The study will involve two visits to the Clinical Center. During the first visit, participants will undergo a medical history and physical exam. During the second visit, investigators will perform the following procedures on study participants: 1) look at the voice box with a nasolaryngoscope, a fine tube through the nose; 2) use MRI \[magnetic resonance imaging\] to record brain activity while participants use their voice to speak; 3) changing sensation in the voice box by dripping a topical anesthetic onto the vocal folds; and 4) using MRI to again record brain activity during speech immediately after applying the topical anesthetic. Participants will receive up to $700 in compensation for their involvement in this study.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
174

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 2, 2003

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2003

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2009

Completed
Last Updated

July 2, 2017

Status Verified

November 5, 2009

Enrollment Period

6.3 years

First QC Date

August 6, 2003

Last Update Submit

June 30, 2017

Conditions

Keywords

Functional Magnetic Resonance ImagingVocalizationSpasmodic DysphoniaMuscular Tension DysphoniaTopical LidocaineVoice DisordersVocal TremorHealthy VolunteerHV

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Intermittent strained hoarseness, uncontrolled voice breaks or changes in pitch are present during vowels, liquids (r \& l) and semi-vowels (w \& y), during speech for adductor SD or prolonged voiceless consonants producing breathy breaks for abductor SD;
  • Less prominent symptoms during whisper, singing or falsetto,
  • Normal voice and vocal fold movement for protective and emotional laryngeal function, such as cough, laugh or cry;
  • A diagnosis of adductor or adductor spasmodic dysphonia based on voice testing and fiberoptic nasolaryngoscopy by a board certified otolaryngologist and Speech-Language Pathologist during the initial interview;
  • Increased phonatory muscle tension in the paralaryngeal and suprahyoid muscles on palpation;
  • A consistent hypertonic laryngeal posture for phonation, such as either an anterior-posterior squeeze (pin-hole posture) or ventricular hyper adduction and an absence of SD or vocal tremor as determined by a Speech-Language Pathologist and the staff otolaryngologist;
  • Vocal tremor during vocalization that primarily involves laryngeal structures;
  • Any individual with a history of one or more of the following contraindications will be excluded from the study:
  • Airway obstruction, smoking or tobacco use;
  • Pulmonary, or neurological disease;
  • Pregnancy as reported by the volunteer or a positive pregnancy result from a urine sample obtained on the day of testing;
  • Psychiatric disorder, under psychiatric care, or on medication for psychiatric disorders. Examples of psychiatric disorders to be excluded are: somatoform disorders, conversion disorders, major depression, schizophrenia or a bipolar disorder. A history of a previous episode of minor reactive depression would not exclude a person from participation;
  • Speech or hearing problems as determined by medical history and examination by the otolaryngologist. A 30 dB HL hearing screening between 500 and 3000 Hz will be conducted if subjects report difficulty following spoken instructions or significant noise exposure;
  • A reduction in the range of vocal fold movement during non-speech tasks such as whistling suggesting either paralysis or paresis, joint abnormality or neoplasm as determined by videolaryngoscopic examination by the staff otolaryngologist;
  • Complete aphonia, a history of airway obstruction or structural abnormalities affect the larynx such as vocal fold nodules, polyps, carcinoma, cysts, contact ulcers, chronic laryngitis as determined by videolaryngoscopic examination by the staff otolaryngologist;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Ludlow CL, Schulz GM, Yamashita T, Deleyiannis FW. Abnormalities in long latency responses to superior laryngeal nerve stimulation in adductor spasmodic dysphonia. Ann Otol Rhinol Laryngol. 1995 Dec;104(12):928-35. doi: 10.1177/000348949510401203.

    PMID: 7492063BACKGROUND
  • Dworkin JP, Meleca RJ, Simpson ML, Garfield I. Use of topical lidocaine in the treatment of muscle tension dysphonia. J Voice. 2000 Dec;14(4):567-74. doi: 10.1016/s0892-1997(00)80012-0.

    PMID: 11130113BACKGROUND
  • Jurgens U. Neural pathways underlying vocal control. Neurosci Biobehav Rev. 2002 Mar;26(2):235-58. doi: 10.1016/s0149-7634(01)00068-9.

    PMID: 11856561BACKGROUND

MeSH Terms

Conditions

Voice DisordersDysphonia

Condition Hierarchy (Ancestors)

Laryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

August 6, 2003

First Posted

August 7, 2003

Study Start

August 2, 2003

Primary Completion

November 5, 2009

Last Updated

July 2, 2017

Record last verified: 2009-11-05

Locations