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Sponsored by: |
National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00001922 |
This research study is designed to improve understanding about voice disorders that are due to uncontrolled muscle contractions affecting the voice box. The type of voice disorder depends on which muscles of the voice box are involved. Abductor spasmodic dysphonia may lead to a weak voice. Adductor spasmodic dysphonia may result in a strangled voice. Muscular tension dysphonia may lead to a strained voice. Some of the major goals of the study are to;
Researchers believe that by understanding better how sensations of the voice box are presented and how the muscles in the larynx respond to those sensations they will be able to develop better treatments for patients suffering from voice disorders. ...
Condition |
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Phonation Disorder Spastic Dysphonia Voice Disorder |
Study Type: | Observational |
Official Title: | Sensory Function in Idiopathic Voice Disorders |
Estimated Enrollment: | 370 |
Study Start Date: | November 1998 |
Study Aim One: To develop and validate objective procedures for quantifying efferent responses to non-invasive laryngeal mechanical and aerodynamic stimulation.
Study Aim Two: To develop and validate an objective test of brain stem evoked responses to laryngeal stimulation using electrical stimulation of the superior laryngeal nerve.
Study Aim Three: To determine whether individuals with idiopathic voice disorders have abnormal conditioning of their responses to laryngeal mechanical and aerodynamic stimulation.
Study Aim Four: To determine whether individuals with idiopathic voice disorders have abnormal brain stem responses to laryngeal stimuli.
Study Aim Five: To evaluate whether sensory input plays a role in symptom generation in laryngeal motor control disorders, temporary bilateral ISLN blockade will be used in idiopathic voice disorders.
Study Aim Six: To evaluate whether the central pathophysiology involved in motor responses to sensory stimulation are altered by botulinum toxin injection in individuals with spasmodic dysphonia.
Study Aim Seven: To evaluate central responses to laryngeal afferent stimulation in normal volunteers and patients with idiopathic voice disorders at rest and during vocalization using magnetoencephalography.
These studies will develop improved non-invasive techniques for the diagnosis of laryngeal sensory disorders and will determine if abnormalities in sensory feedback modulation are involved in idiopathic voice disorders. Such findings will lead to improved understanding of the pathophysiology and differential diagnosis of idiopathic voice disorders and may ultimately improve treatment approaches to these disorders.
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
EXCLUSION CRITERIA - Normal Volunteers:
Any individual with: 1) an implant or surgical clip - implanted neural stimulator, implanted cardiac pacemaker or autodefibrillator, cochlear implant, ocular implant, aneurysm clip, artificial heart valve, insulin pump, orthopedic pins or prosthesis: 2) a foreign body - metal shavings, shrapnel, orthodontic braces, tattoos or permanent eye liner; and/or, 3) any other implanted device or foreign body not listed above that is possibly ferromagnetic will also be excluded from study seven because of contraindications for magnetic resonance imaging.
INCLUSION CRITERIA - Patients with Spasmodic Dysphonia:
EXCLUSION CRITERIA - Patients with Spasmodic Dysphonia:
INCLUSION CRITERIA - Patients with Adductor SD:
INCLUSION CRITERIA - Patients with Abductor SD:
EXCLUSION CRITERIA - Patients with Adductor SD:
EXCLUSION CRITERIA - Patients with Abductor SD:
INCLUSION CRITERIA - Patients with Muscular Tension Dysphonia:
EXCLUSION CRITERIA - Patients with Muscular Tension Dysphonia:
OTHER EXCLUSION CRITERIA:
Subjects will be excluded if they have a history of rheumatic fever, mitral valve prolapse or cardiac arrhythmias, as determined by medical history, physical and EKG.
Individuals who might be at risk for endocarditis will be excluded.
All patients over the age of 40 years of age will have an electrocardiogram on the day of the study and if there are any abnormalities they will not be allowed to participate.
Pregnancy.
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 990009, 99-N-0009 |
Study First Received: | November 3, 1999 |
Last Updated: | November 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00001922 |
Health Authority: | United States: Federal Government |
Evoked Response Spasmodic Dysphonia Aerodynamic Vibration Laryngeal |
Voice Disorders Laryngeal Brainstem Evoked Responses Long-latency Responses Muscular Tension Dysphonia |
Spasmodic dysphonia Signs and Symptoms Otorhinolaryngologic Diseases Respiratory Tract Diseases |
Spastic dysphonia Neurologic Manifestations Laryngeal Diseases Voice Disorders |
Pathologic Processes Disease Nervous System Diseases |