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Laryngeal Resistance in Abductor Spasmodic Dysphonia
Sponsor study identifier
Secondary identifiers
interventional
30
1 country
1
Study Start
May 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
June 2003
Date type not reportedThis date has not been verified as actual or estimated.
This study will investigate and compare the air stream during voice production in patients with abductor spasmodic dysphonia and in normal volunteers. People with abductor spasmodic dysphonia have uncontrolled muscle spasms during speech, resulting in a weak voice. A better understanding of the abnormalities of this disorder may help in the development of more effective treatments. Healthy volunteers and patients with abductor spasmodic dysphonia may be eligible for this study. Candidates will have a physical examination and medical history. (Patients will be videotaped and voice-recorded during the medical interview for review by specialists who will identify the type and severity of their speech disorder.) All candidates will also undergo a procedure called flexible fiberoptic laryngoscopy to record the movement of the vocal folds during speech, breathing and other tasks such as singing, whistling and prolonging vowels. For this test, the inside of the nose is sprayed with an anesthetic (lidocaine) to numb the nasal cavity and a decongestant (oxymetazoline) to widen the nasal passage. Then, a thin flexible tube called a nasolaryngoscope is passed through the nose to the larynx (voice box). A camera attached to the eyepiece of the nasolaryngoscope records the movements of the vocal folds. Participants will then have an airway interruption test to detect pressure changes in the voice box during production of continuous sounds. A nose clip is placed over the subject's nose and two sensor devices are placed on the neck to pick up changes in movement and position of the vocal cords during voicing. A mouthpiece is placed in the mouth, and subjects are asked to say "ah" continuously at a specified sound level. This voicing is repeated 33 times with periodic breaks. Patients only will also be given an injection of botulinum toxin. These injections are effective, in varying degrees, in about 60 percent of patients with abductor spasmodic dysphonia. This study will use a different approach to botulinum toxin injections to test their effect in patients with pressures higher than normal. Rather than inject the posterior cricoarytenoid muscle or the cricothyroid muscle, as is typically done, the thyroarytenoid muscle, which closes the voice box, will be injected on one side. A second one-sided injection may be given after 2 or 3 weeks if no effect is seen after the first injection. Speech will be recorded at each visit to measure any change in symptoms after the injection.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2003
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2001
Date type not reportedThis date has not been verified as actual or estimated.
May 4, 2001
Actual (reported)May 7, 2001
Actual (reported)June 2003
Date type not reportedThis date has not been verified as actual or estimated.
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National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892, United States
Blitzer A, Brin MF, Stewart C, Aviv JE, Fahn S. Abductor laryngeal dystonia: a series treated with botulinum toxin. Laryngoscope. 1992 Feb;102(2):163-7. doi: 10.1288/00005537-199202000-00011.
Bocchino JV, Tucker HM. Recurrent laryngeal nerve pathology in spasmodic dysphonia. Laryngoscope. 1978 Aug;88(8 Pt 1):1274-8. doi: 10.1288/00005537-197808000-00008.
Finnegan EM, Luschei ES, Barkmeier JM, Hoffman HT. Sources of error in estimation of laryngeal airway resistance in persons with spasmodic dysphonia. J Speech Hear Res. 1996 Feb;39(1):105-13. doi: 10.1044/jshr.3901.105.
First Submitted
May 4, 2001
First Posted
May 7, 2001
Study Start
May 2001
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
June 2003
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Last Updated
March 4, 2008
Record last verified: 2003-06
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Source: ClinicalTrials.gov.
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