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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 3, 1999 | ||||||||
| Last Updated Date | August 24, 2009 | ||||||||
| Start Date ICMJE | November 1998 | ||||||||
| Estimated Primary Completion Date | July 2001 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE |
Determine the feasibility of using PET scanning methodologies with sestamibi. | ||||||||
| Change History | Complete list of historical versions of study NCT00001922 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE |
Evaluate Pgp reversal in patients receiving the Pgp antagonist tariquidar. | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Sensory Function in Idiopathic Voice Disorders | ||||||||
| Official Title ICMJE | Sensory Function in Idiopathic Voice Disorders | ||||||||
| Brief Summary | 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. ... |
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| Detailed Description | 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 370 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | July 2001 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
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. |
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| Gender | Both | ||||||||
| Ages | 20 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00001922 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 990009, 99-N-0009 | ||||||||
| Study Sponsor ICMJE | National Institute of Neurological Disorders and Stroke (NINDS) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | October 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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