Treatment Trials

12 Clinical Trials for Various Conditions

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SUSPENDED
A Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Tolerability of Asenapine With Flexible Dosing From 5mg to 20mg in Adults With Developmental Stuttering
Description

The purpose of this research study is to find out the potential benefits and safety of asenapine (Saphris®) in adults who suffer from the developmental form of stuttering. It is hypothesized that individuals who are randomly assigned to asenapine will have an improvement in speech as compared to a placebo.

Conditions
COMPLETED
Safety and Efficacy Study of the Investigational Drug Pagoclone, in the Treatment of Persistent Developmental Stuttering (PDS)
Description

This is a research study of the investigational drug, Pagoclone, in the treatment of persistent developmental stuttering (PDS), which includes frequent repetitions or prolongations of sounds or syllables or words, or frequent hesitations or pauses that disrupt the flow of speech. Pagoclone is an investigational drug, so it is not approved by the United States Food and Drug Administration.

COMPLETED
EXPRESS: Examining Pagoclone for Persistent Developmental Stuttering Study
Description

The objective of the study is to determine the effects of pagoclone on the symptoms of Persistent Developmental Stuttering, using a flexible dosing titration regimen on persistent developmental stuttering in patients 18 to 65 years of age.

COMPLETED
Dopamine Function in Developmental Stuttering
Description

This study will use positron emission tomography (PET) to examine the role of the chemical messenger dopamine in stuttering. It will measure and compare the number of dopamine receptors and the amount of dopamine released in the brains of stutterers with that of normal volunteers. The results may provide information about how drugs that block dopamine's effect might work to enable fluent speech. Healthy normal volunteers and people with developmental stuttering between the ages of 18 and 55 may be eligible for this study. Candidates will be screened with a medical history and possibly a physical examination and laboratory tests. Participants will have a hearing test and cognitive function tests to measure speech, language, memory and visual skills. In addition, they will undergo the following procedures: * PET scanning to measure brain blood flow and dopamine distribution in the brain. PET uses radioactive materials to show cellular activity in specific tissues of the body. Before starting the procedure, a thin plastic tube (intravenous, or IV line) is placed in a vein in each arm of the subject and a special plastic mask is molded to the face. (The mask is used to insure that the position of the head does not change during the scan.) For the scan, the subject lies on a bed that is positioned into the scanner. A preliminary "transmission" scan is done to make necessary measurements and adjustments. Following this scan, 10 injections of radioactive water are given through an IV line. During these injections, the subject performs a series of speech tasks-such as singing, telling a story, or reciting nursery rhymes-that will elicit either fluent speech or stuttering. A special camera detects the radiation emitted and produces images of brain blood flow during stuttering and normal speech. Next, raclopride (a radioactive material that attaches to dopamine receptors on the cell surface) is given through an IV line and more pictures of the brain are taken. Fifty minutes after the raclopride injection, amphetamine-a drug that increases brain dopamine levels-is injected through the other IV line and more pictures are taken to show dopamine distribution in the brain. Fifty minutes after the amphetamine infusion, the IV lines are removed. * Magnetic resonance imaging (MRI) of the brain to complement and interpret information from the PET scans. MRI uses a strong magnetic field and radio waves to show structural changes in tissues. The subject lies on a table surrounded by a metal cylinder (the scanner). During the procedure, which may take from 20 minutes to 2 hours, subjects may be asked to perform simple tasks, such as speaking or moving their arms. They can speak with a staff member via an intercom at all times during the procedure and can be moved out of the machine any time they request. Participants may be asked to return for up to two scanning sessions within a year. For these scans, only 1 injection of radioactive water will be given.

RECRUITING
Investigating Speech Sequencing in Neurotypical Speakers and Persons With Disordered Speech
Description

Persistent developmental stuttering affects more than three million people in the United States, and it can have profound adverse effects on quality of life. Despite its prevalence and negative impact, stuttering has resisted explanation and effective treatment, due in large part to a poor understanding of the neural processing impairments underlying the disorder. The overall goal of this study is to improve understanding of the brain mechanisms involved in speech motor planning and how these are disrupted in neurogenic speech disorders, like stuttering. The investigators will do this through an integrated combination of experiments that involve speech production, functional MRI, and non-invasive brain stimulation. The study is designed to test hypotheses regarding the brain processes involved in learning and initiating new speech sound sequences and how those processes compare in persons with persistent developmental stuttering and those with typical speech development. These processes will be studied in both adults and children. Additionally, these processes will be investigated in patients with neurodegenerative speech disorders (primary progressive aphasia) to further inform the investigators understanding of the neural mechanisms that support speech motor sequence learning. Together these experiments will result in an improved account of the brain mechanisms underlying speech production in fluent speakers and individuals who stutter, thereby paving the way for the development of new therapies and technologies for addressing this disorder.

TERMINATED
Non-invasive Brain Stimulation in Adults Who Stutter
Description

Research studies in stuttering have shown that activity patterns in certain brain areas differ in people who stutter compared to people who do not stutter when speaking. The purpose of this study is to investigate how mild, non-invasive brain stimulation applied consecutively for five days affects speech relevant brain areas, which may in turn affect speech fluency and speaking-related brain activity in people who stutter.

NOT_YET_RECRUITING
Transcranial Alternating Current Stimulation (tACS) in Stuttering
Description

The purpose of this study is to investigate how mild, noninvasive electrical brain stimulation affects speech relevant brain areas, which may in turn affect speech fluency and speaking-related brain activity in people that stutter. The long-term goal of this study is to test the therapeutic potential of transcranial alternating current stimulation (tACS) for the treatment of stuttering. The study team hypothesizes that if stuttering involves impaired initiation of motor programs, delta-tuned tACS will strengthen communication between brain regions and decrease stuttering. Therefore, the study team delta-tuned sensorimotor tACS will be paired with fluency-induced speech (choral reading), which is hypothesized to decrease stuttering via improved auditory motor integration. However, if the primary impairment lies in planning of motor programs, the study team hypothesizes that theta-tuned tACS will strengthen communication between prefrontal and temporal brain regions and decrease stuttering.

RECRUITING
The Development of Stuttering in Young Children
Description

The goal of this longitudinal research is to learn why some children "grow out" of stuttering, while others persist. Children who do and do not stutter aged 3-6 years are eligible to participate in our study. During the study, children's speech and language abilities will be assessed with standardized assessments, and they complete several child-friendly experiments. During these experiments, brain activity will be recorded using specialized caps while children describe pictures, children will speak in two virtual-reality scenarios, and produce speech while keeping to a beat.

RECRUITING
Auditory Prediction and Error Evaluation in the Speech of Individuals Who Stutter
Description

Stuttering negatively impacts communication and reduces the overall quality of life and well-being of individuals who stutter. This study will provide a strong foundation for developing neural and behavioral interventions for stuttering. Participants will be asked to name pictures, read words/sentences silently or aloud, and listen to speech and nonspeech sounds while their speech, muscle, and brain signals are collected. Some participants may also receive brain stimulation while reading and speaking.

RECRUITING
Exploring the Nature, Assessment and Treatment of Stuttering
Description

The purposes of this study are to 1) investigate potential speech, language, and psychosocial contributions to the experience of stuttering in monolingual and multilingual speakers, and to 2) evaluate interdisciplinary, telehealth, and speech-language pathology treatment methods and clinical training specific to fluency disorders.

COMPLETED
Study of Brain Activity During Speech Production and Speech Perception
Description

The purpose of this study is to gain a better understanding of the brain's activity and organization in the development of speech disorders. It will compare brain activity in people with normal speech development with those who stutter or who have a phonological disorder (a deficit in how the brain processes speech sounds). Stuttering and phonological disorders emerge during the critical period of speech development between 2.5 and 12 years of age. During this period, the brain is much more adaptable for speech development than it is after puberty. This study will examine how the brain organization for speech production and perception develops normally during the critical period and how the normal pattern is altered when stuttering and phonological disorders become chronic problems, persisting throughout life. Volunteer adults and children with and without speech disorders may participate in this study. Eligibility screening will include a brief neurological and physical examination and tests to determine normal speech or a speech disorder. The speech testing will be videotaped. The subject will speak aloud, describe pictures, recall words or numbers, imitate speech sounds and words, and perform some listening tests. Study participants will undergo magnetic resonance imaging (MRI) to study brain activity. For this procedure, the subject lies on a stretcher that is moved into a donut-shaped machine with a strong magnetic field. During the MRI scan, the subject will perform simple tasks, such as listening to speech or other sounds and saying nonsense words. The procedure should take less than 60 minutes, and usually takes from 20 to 40 minutes.

COMPLETED
Characteristics of Idiopathic Familial Speech Disorders
Description

According to studies, speech disorders with unknown causes (idiopathic) affect approximately 5% of the population at some point in their life. Some of these disorders like, stuttering and cluttering, are known for being detected early, during speech development. Stuttering is characterized by sound and syllable repetitions and consonant/vowel prolongations. When stuttering is moderate to severe, it can interfere with a person's job and social activities. Speech articulation disorders are characterized by omissions, or substitutions of speech sounds. The speech of a person who clutters is often difficult to understand. People are often unaware of the errors they make when speaking causing treatment of the condition to be very difficult. The purpose of this research is to study an extended family whose members exhibit a pure form of speech articulation disorders In addition, the study will use data and information gathered from the study and use it to develop guidelines (criteria) for defining and differentiating patients with speech disorders.