5 Clinical Trials for Various Conditions
The purpose of this study is to pilot test a version of the intervention that has been tailored for participants with dysphonia. The study seeks to determine if the adapted intervention: a) increases perceived control over voice-related stressors and b) decreases stress and distress resulting from voice problems. The study will also explore the usability and acceptability of the program. The goal is to help people with voice problems achieve better voice and quality of life outcomes.
This study will examine how the brain controls speech in patients with spasmodic dysphonia, a voice disorder that involves involuntary spasms of muscles in the larynx (voice box), causing breaks in speech. Although the causes of spasmodic dysphonia are unknown, recent studies found changes in brain function in patients with the disorder that may play a role in its development. People between 21 and 80 years of age with adductor spasmodic dysphonia may be eligible for this study. Candidates are screened with the following procedures: Medical history and physical examination. Nasolaryngoscopy to examine the larynx. 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. The subject may be asked to talk, sing, whistle and say prolonged vowels during the procedure. The nasolaryngoscope is connected to a camera that records the movement of the vocal cords during these tasks. Voice and speech recording to measure the type and severity of voice disorder. Subjects are asked questions about their voice disorder and their voice is recorded while they repeat sentences and sounds. Participants undergo positron emission tomography (PET) and magnetic resonance imaging (MRI) of the brain, as follows: PET: A catheter is placed in a vein in the subject s arm to inject a radioactive substance called a tracer that is detected by the PET scanner and provides information on brain function. \[11C\]flumazenil is used in one scanning session and \[11C\]raclopride is used in another. For the scan, the subject lies on a bed that slides in and out of the doughnut-shaped scanner, wearing a custom-molded mask to support the head and prevent it from moving during the scan. For the first scan the subject lies quietly for 60 minutes. For the second scan, the subject lies quietly for 50 minutes and is then asked to say sentences during another 50 minutes. The amount of radiation received in this study equals to a uniform whole-body exposure of 0.9 rem, which is within the dose guideline established by the NIH Radiation Safety Committee for research subjects. The guideline is an effective dose of 5 rem received per year. MRI: This procedure uses a strong magnetic field and radio waves instead of X-rays to obtain images of the brain. The subject lies on a table that slides into the scanner, a narrow metal cylinder, wearing ear plugs to muffle loud knocking sounds that occur during the scan. Images of the brain structure are obtained while the subject lies still in the machine for 10 minutes. This is followed by functional MRI (fMRI) for 60 minutes, in which pictures are taken while the subject speaks, showing changes in brain regions that are involved in speech production.
Using a comprehensive approach of clinico-behavioral testing, neuroimaging and pharmacogenetics, the researchers will examine the clinical effects of sodium oxybate and the matched placebo on voice symptoms in spasmodic dysphonia and voice tremor.
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. ...
Some voice disorders are caused by uncontrolled muscle actions that affect the larynx or voice box. The purpose of this study is to understand 1) how the brain controls voice production; 2) how changes in sensation within the voice box affect brain control of the voice box; 3) how the central nervous system is affected when people have motor or sensory abnormalities that affect the voice box; and 4) whether patients with voice disorders differ from people without voice disorders in the way the brain controls the voice box. By better understanding these concepts, researchers hope to develop improved treatments for patients with voice disorders. Forty-five healthy adult volunteers and 90 patients with voice disorders will participate in this study. Participants must be between the ages of 20 and 70. The study will involve two visits to the Clinical Center. During the first visit, participants will undergo a medical history and physical exam. During the second visit, investigators will perform the following procedures on study participants: 1) look at the voice box with a nasolaryngoscope, a fine tube through the nose; 2) use MRI \[magnetic resonance imaging\] to record brain activity while participants use their voice to speak; 3) changing sensation in the voice box by dripping a topical anesthetic onto the vocal folds; and 4) using MRI to again record brain activity during speech immediately after applying the topical anesthetic. Participants will receive up to $700 in compensation for their involvement in this study.