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Home > "S" Clinical Trials Conditions > Sensory Function in Idiopathic Voice Disorders  Sensory Function in Idiopathic Voice Disorders
Sensory Function in Idiopathic Voice Disorders
For Condition: Phonation Disorder,Spastic Dysphonia,Voice Disorder
Status: Recruiting
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) ,
Synopsis: 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; 1. understand how sensation from the voice box affects voice and speech production 2. develop better ways to diagnose sensation abnormalities affecting the voice box 3. determine if patients with voice disorders differ from persons without voice disorders in the way they respond to sensory information from their voice box 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.
Details: 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 idiopatic 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA - Normal Volunteers: - Normal volunteers between the ages of 18 and 80 years of age will be selected after a screening examination. - The normal volunteers will be without cardiac, pulmonary, neurological, otolaryngological, psychiatric or speech and hearing problems as determined by medical history and examination by the otolaryngologist. - None of the subjects included for study will have 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. EXCLUSION CRITERIA - Normal Volunteers: - No smokers or tobacco users will be included in the study. - Subjects with a history of a psychiatric disorder, under the care of a psychiatrist, or on medications for treatment of a psychiatric disorder will be excluded from study. Examples of psychiatric disorders to be excluded are: somatoform disorders, conversion disorders, currently under treatment for a major depression, or a history of schizophrenia or a bipolar disorder. However, a history of a previous episode of a minor reactive depression would not exclude a person from participation. INCLUSION CRITERIA - Patients with Spasmodic Dysphonia: - Symptoms present during speech and not apparent at rest. - Symptoms less evident during whisper, singing or falsetto. - Symptoms become worse with prolonged speaking, practice or anxiety. - Reflexive and emotional aspects of voice function are unaffected, such as coughing, laughter or crying. - Only individuals with regularly occurring symptoms on the order of no less than one voice break per sentence and no more than 5 or so per sentence will be included for study. EXCLUSION CRITERIA - Patients with Spasmodic Dysphonia: - Any patient with a history of airway obstruction will be excluded from the study. Structural abnormalities affecting the larynx such as vocal fold nodules, polyps, carcinoma, cysts, contact ulcers, or inflammation (laryngitis). - Reduction in vocal fold movement range during non-speech tasks such as whistling which would suggest either paralysis or paresis, joint abnormality or neoplasm. - No smokers or tobacco users will be included in the study. - Subjects with a history of a psychiatric disorder, under the care of a psychiatrist, or on medications for treatment of a psychiatric disorder will be excluded from study. Examples of psychiatric disorders to be excluded are: somatoform disorders, conversion disorders, currently under treatment for a major depression, or a history of schizophrenia or a bipolar disorder. However, a history of a previous episode of a minor reactive depression would not exclude a person from participation. - Patients whose symptoms vary during their initial interview, and/or who report periods of symptom remission and are atypical of spasmodic dysphonia will not be included. - Patients with whispering aphonia or complete aphonia will not be included. - Patients with a constant voice quality abnormality will not be included. - Patients with muscular tension dysphonia will be included in a separate subject group and not included in spasmodic dysphonia. - Spasmodic dysphonia and muscular tension dysphonia are disorders of adult onset usually first occurring after 40 years of age, therefore, we do not plan to include children in this study. INCLUSION CRITERIA - Patients with Adductor SD: - Intermittent strained hoarseness and uncontrolled voice breaks or changes in pitch during vowels in speech. - Symptoms most easily heard on vowels, liquids (r and l) or semivowel sounds (w and y). - Intermittent hyperadduction of the vocal folds interfering with air flow through the folds during vowels in speech, stopping vocal fold vibration, and resulting in voice interruptions or breaks. When the hyperadduction is less severe, voicing may become strained or a rapid change in pitch may occur. In the milder forms of the disorder, only intermittent irregular catches will be heard in the voice on a vowel every couple of sentences. In the moderate form, the voice is constantly breaking or bursting as the patient tries to force air through excessively tight vocal folds. The speech has intermittent hoarseness and reduced volume because very little air can be forced through the vocal folds. In such individuals voice may be heard only at the end of sentences as the vocal folds release at the end of speech phrases. The speech is excessively slow, tight and effortful. EXCLUSION CRITERIA - Patients with Adductor SD: - Any patient with a history of airway obstruction will be excluded from the study. - No smokers or tobacco users will be included in the study. - Patients with cardiac, pulmonary, neurological, otolaryngological, psychiatric or speech and hearing problems as determined by medical history and examination by a physician. - Structural abnormalities affecting the larynx such as vocal fold nodules, polyps, carcinoma, cysts, contact ulcers, or inflammation (laryngitis). - Reduction in vocal fold movement range during non-speech tasks such as whistling which would suggest either paralysis or paresis, joint abnormality or neoplasm. - Patients whose symptoms vary during their initial interview, and/or who report periods of symptom remission and are atypical of spasmodic dysphonia will not be included. - Patients with whispering aphonia or complete aphonia will not be included. - Patients with muscular tension dysphonia will be included in a separate subject group and not included in spasmodic dysphonia. INCLUSION CRITERIA - Patients with Abductor SD: - Prolonged vocal fold opening during voiceless consonants with excessive breathiness as individual experience difficulties in closing the vocal folds to produce vowels following voiceless consonants (p, t, k, s, f, h, th). Sounds such as (s, h or k) when coming just before open vowels such as (ah and uh) as in home, coffee and puppy are usually most affected. - A breathy voice quality, uncontrolled pitch elevations on vowel initiation, difficulty coordinating breathing with speech, and complaints of excessive air loss while speaking. These individuals usually have similar problems in singing but normal laughter and coughing. In the milder forms only intermittent prolongations of a few voiceless consonants are heard. In the more severe forms more voiceless consonants are affected, speech initiation becomes more difficult and voice becomes breathy. In the most severe forms of both adductor and abductor spasmodic dysphonia, individuals may resort to whispering which is less affected and much less effortful. EXCLUSION CRITERIA - Patients with Abductor SD: - Any patient with a history of airway obstruction will be excluded from the study. - No smokers or tobacco users will be included in the study. - Patients with cardiac, pulmonary, neurological, otolaryngological, psychiatric or speech and hearing problems as determined by medical history and examination by a physician. - Structural abnormalities affecting the larynx such as vocal fold nodules, polyps, carcinoma, cysts, contact ulcers, or inflammation (laryngitis). - Reduction in vocal fold movement range during non-speech tasks such as whistling which would suggest either paralysis or paresis, joint abnormality or neoplasm. - Patients whose symptoms vary during their initial interview, and/or who report periods of symptom remission and are atypical of spasmodic dysphonia will not be included. - Patients with whispering aphonia or complete aphonia will not be included. - Patients with muscular tension dysphonia will be included in a separate subject group and not included in spasmodic dysphonia. INCLUSION CRITERIA - Patients with Muscular Tension Dysphonia: 1) Increased phonatory muscle tension in the paralaryngeal and suprahyoid muscles on palpation. 2) Constant elevation of the larynx in the neck during speech. 3) A consistent hypertonic laryngeal posture for phonation, either an open posterior glottic chink between the arytenoid cartilages on phonation, an anterior-posterior squeeze (pin hole posture) or ventricular hyperadduction. 4) A normal appearing larynx. EXCLUSION CRITERIA - Patients with Muscular Tension Dysphonia: 1) Cardiac, pulmonary, neurological, otolaryngological, psychiatric or speech and hearing problems as determined by medical history and examination by an otolaryngologist, will be excluded from the study. 2) Reduction in the range of vocal fold movement during non-speech tasks such as whistling suggesting either paralysis or paresis, joint abnormality or neoplasm. 3) Intermittent symptoms during their initial interview, reports of periods of symptom remission or spasmodic breaks in voicing typical or either adductor or abductor spasmodic dysphonia. 4) A 30 dB HL screening between 500 and 3000 Hz will be conducted if subjects report difficulty following spoken instructions and a history of hearing loss or significant noise exposure. 5) No smokers or tobacco users will be included in the study. 6) Exclude mucosal changes such as vocal nodules or polyps. 7) Subjects with a history of a psychiatric disorder, under the care of a psychiatrist, or on medications for treatment of a psychiatric disorder will be excluded from study. Examples of psychiatric disorders to be excluded are: somatoform disorders, conversion disorders, currently under treatment for a major depression, or a history of schizophrenia or a bipolar disorder. However, a history of a previous episode of a minor reactive depression would not exclude a person from participation. 8) Spasmodic dysphonia and muscular tension dysphonia are disorders of adult onset usually first occurring after 40 years of age, therefore, we do not plan to include children in this study. OTHER EXCLUSION CRITERIA: Subjects will be excluded if they have a history of rhumatic 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.
Total Enrollment: 365
Location and Contact Information:
National Institute of Neurological Disorders and Stroke (NINDS) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 990009; 99-N-0009
Study Start Date: November 5, 1998
Record last reviewed: October 7, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001922
Other Voice Disorder Studies:
1. Sensory Function in Idiopathic Voice Disorders
2. Characteristics of Idiopathic Familial Voice Disorders
3. Study of Air Stream in Voice Production
Related Studies:
Other Voice Disorder Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Sensory Function in Idiopathic Voice Disorders
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