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Neuropathology of Spasmodic Dysphonia
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), May 2008
Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00118586
  Purpose

This study will look for abnormalities in a brain of persons affected with spasmodic dysphonia, a form of movement disorder that involves involuntary "spasms" of the muscles in the vocal folds causing breaks of speech and affecting voice quality. The causes of this disorder are not known. The study will compare results of magnetic resonance imaging (MRI) in people with spasmodic dysphonia and in healthy volunteers.

People with adductor or abductor spasmodic dysphonia and healthy volunteers may be eligible for this study. Candidates are screened with a medical history, physical examination, and a test called nasolaryngoscopy. For this test, the inside of the subject's nose is sprayed with a decongestant, and a small, flexible tube called a nasolaryngoscope is passed through the nose to the back of the throat to allow examination of the larynx (voice box). During this procedure, the subject is asked to perform tasks such as talking, singing, whistling, and saying prolonged vowels. The nasolaryngoscope is connected to a camera to record the movements of the vocal folds during these tasks.

Eligible participants then undergo MRI of the brain. MRI uses a strong magnetic field and radio waves instead of x-rays to obtain images of body organs and tissues. For this test, the subject lies on a table that slides into the MRI scanner, a narrow metal cylinder, wearing ear plugs to muffle loud knocking sound that occurs during the scan. During MRI anatomical images of the brain are obtained. Subject may be asked to participate in up to two scanning sessions. Each session takes about 1-1/2 hours.

Participants may also be asked to volunteer for a brain donation program which is optional. Information gained from donated tissue may lead to better treatments and potential cures for spasmodic dysphonia.


Condition
Voice Disorders

Genetics Home Reference related topics: early-onset primary dystonia
MedlinePlus related topics: Voice Disorders
U.S. FDA Resources
Study Type: Observational
Official Title: Neuropathological Basis of Spasmodic Dysphonia and Related Voice Disorders

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 360
Study Start Date: July 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Healthy research volunteers and patients with SD, MTD, and VT from 21 years of age will be eligible for the study.

SD PATIENTS:

  • A diagnosis of adductor or abductor SD will be based on voice testing and fiberoptic nasolaryngoscopy conducted during the initial interview by an otolaryngologist and speech-language pathologist according to following criteria:

    1. Intermittent strained hoarseness, uncontrolled voice breaks or changes in pitch during vowels, liquids (r & l), semivowels (w & y), during speech are present in adductor SD, or
    2. Prolonged voiceless consonants producing breathy breaks are present in abductor SD,
    3. Less prominent symptoms during whisper, singing or falsetto,
    4. Normal voice and vocal fold movement for protective and emotional laryngeal function, such as cough, laugh or cry.
  • Postmortem brain and larynx tissue from SD patients deceased from other than neurological, psychiatric, laryngological causes which would not affect our study as determined by medical history.

MTD PATIENTS:

  • 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 hyperadduction and an absence of SD or vocal tremor as determined by a Speech-Language Pathologist and the staff otolaryngologist;
  • Exclusion of other laryngeal pathologies based on a fiberoptic nasolaryngoscopic examination conducted during the initial interview by the staff otolaryngologist.

VT PATIENTS:

  • Vocal tremor during vocalization that primarily involves laryngeal structures;
  • Exclusion of other laryngeal pathologies based on a fiberoptic nasolaryngoscopic examination conducted during the initial interview by the staff otolaryngologist.

CONTROLS:

  • Normal vocal function refers to normal voice quality with a negative history of voice or laryngeal disorders.
  • Research volunteers without neurological, psychiatric, otolaryngological problems as determined by medical history and examination by a physician.

EXCLUSION CRITERIA:

  • Pregnant women will be excluded from the study until a time when they are no longer pregnant.
  • Any individual with a medical history or postmortem diagnoses of one or more of the following contraindications will be excluded from the study:

SD, MTD, AND VT PATIENTS:

  • Other laryngeal pathologies as determined by medical history and fiberoptic nasolaryngoscopic examination conducted during the initial screening by the otolaryngologist and speech-language pathologist, such as:

    1. Vocal fold paralysis, paresis, joint abnormality, or neoplasm;
    2. Vocal fold nodules, polyps, carcinoma, cysts, contact ulcers, or chronic laryngitis;
    3. Swallowing problems; airway obstruction
  • Speech problems as determined by medical history and examination by the otolaryngologist and speech-language pathologist.
  • Neurological diseases and disorders such as stroke affecting the brain regions of interest, movement disorders (e.g., Huntington disease, chorea, myoclonus, Gilles de la Tourette syndrome, Parkinson's disease, progressive supranuclear palsy, and neuroleptic-induced syndromes), brain tumors, traumatic brain injury with loss of consciousness, genetic diseases of the CNS, chronic infections of the nervous system, ataxias, myopathies, myasthenia gravis, demyelinating diseases, epilepsy, alcoholism, and drug dependence.
  • Psychiatric diseases and disorders such as schizophrenia, major and/or bipolar depression, and obsessive-compulsive disorder.

CONTROLS:

  • Laryngeal pathologies as determined by medical history and fiberoptic nasolaryngoscopic examination conducted during the initial screening by the otolaryngologist and speech-language pathologist, such as:

    1. Spasmodic dysphonia, muscular tension dysphonia, voice tremor;
    2. Vocal fold paralysis, paresis, joint abnormality, or neoplasm;
    3. Vocal fold nodules, polyps, carcinoma, cysts, contact ulcers, or chronic laryngitis;
    4. Swallowing problems;
  • Speech problems as determined by medical history and examination by the otolaryngologist and a speech-language pathologist.
  • Neurological diseases and disorders such as stroke affecting the brain regions of interest, movement disorders (e.g., Huntington disease, chorea, myoclonus, Gilles de la Tourette syndrome, essential tremor, Parkinson's disease, progressive supranuclear palsy, and neuroleptic-induced syndromes), tumors involving the brain region of interest, genetic diseases of the CNS, traumatic brain injury with loss of consciousness chronic infections of the nervous system, ataxias, myopathies, myasthenia gravis, demyelinating diseases, epilepsy, alcoholism, and drug dependence.
  • Psychiatric diseases and disorders such as schizophrenia, major and/or bipolar depression, and obsessive-compulsive disorder.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00118586

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: 050189, 05-N-0189
Study First Received: July 8, 2005
Last Updated: July 18, 2008
ClinicalTrials.gov Identifier: NCT00118586  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Neuroanatomy
Brain Damage
Dystonia
Pathology
Brain Imaging
Spasmodic Dysphonia
SD
Focal Dystonia
Healthy Volunteer
HV

Study placed in the following topic categories:
Dystonic Disorders
Otorhinolaryngologic Diseases
Spastic dysphonia
Dystonia
Healthy
Signs and Symptoms
Spasmodic dysphonia
Respiratory Tract Diseases
Neurologic Manifestations
Voice Disorders
Laryngeal Diseases
Brain Injuries
Focal dystonia

Additional relevant MeSH terms:
Pathologic Processes
Disease
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009