214 Clinical Trials for Various Conditions
The goal of this clinical trial is to compare speech therapy outcomes in children ages 18 months to 16 years who participate in weekly speech therapy with home programming versus every-other week speech therapy with home programming in outpatient speech therapy. The main question it aims to answer is: Does a change in how often speech therapy sessions are delivered show an increased benefit in language and articulation standardized test scores? Participants will be randomly assigned to either (1) weekly or (2) every-other-week speech therapy for a total of 8 sessions. Researchers will compare these two groups to see if there are differences in speech outcomes.
Speech Therapy, Language Disorders in Children, Articulation Disorders in Children, Communication Disorder, Childhood, Pediatric
Study Description: It may be in the interest of the NIDCD Clinical Research Program (CRP) to collect clinical data or specimens generated in the diagnosis and treatment of head and neck or communication disorders and to evaluate patients to determine candidacy for intramural clinical studies. This protocol will provide the administrative vehicle to enable the evaluation and provision of clinical care for patients with head and neck and communication disorders by the NIDCD CRP, Clinical Center, and consult services. No investigational therapies will be administered in this study. Objectives and Endpoints: (Summation)To collect clinical data or specimens generated in the diagnosis and treatment of head and neck or communication disorders (Summation)To evaluate patients to determine candidacy for intramural clinical studies Study Population: Patients at risk, suspected of having, have a history of, or currently have a diagnosed head and neck or communication disorder referred to NIDCD Clinical Investigators by the Intramural Consult Service or community providers Description of Sites: NIH Clinical Center Study Duration: 10 years
Head and Neck Carcinoma
Smarty Ears has developed a prototype of an innovative therapeutic training system to improve speech perception in noise by training children on interrupted noise (which has silent intervals that allow for fragments of the target to be heard). The study will attempt to validate the technology and gather initial design feedback from clinicians and caregivers and from children with ASD and HL.
Speech Perception
The cerebellum has been linked to cognitive and emotional functions and there is increasing evidence that damage to posterior portions of the cerebellum can result in frontal-executive, visuospatial, and verbal deficits, including dysprosodia, and affective changes including blunting of affect or disinhibited and inappropriate behavior. Based on preliminary clinical observations and tests performed in the investigator's clinic, disorders of emotional communication may also be associated with cerebellar dysfunction. Emotional communication includes the production and comprehension of facial and prosodic expressions and is critical to maintaining positive and supportive relationships. Deficits in emotional communication can have devastating effects on relationships and on quality of life for those affected. Although deficits in affect and prosody have been reported in association with posterior cerebellar disorders, there are currently no studies systematically investigating emotional communication in individuals with cerebellar dysfunction. It is known that the cerebellum has strong connections with the cerebral cortex, especially the frontal lobes, and that cortical damage from stroke or neurodegenerative disease can result in disorders of emotional communication. Impairments in the integrity of cerebellar-cerebral networks from cerebellar disease may produce similar deficits in emotional communication. The purpose of this study is to systematically investigate and describe deficits in emotional communication in a series of patients with cerebellar disease. Participants will be individuals diagnosed with posterior cerebellar degeneration or damage from a non-hemorrhagic infarction, and age-matched neurologically healthy controls. Assessment will include a battery of tests of neuropsychological function as well as tests of emotional communication. Comprehension of emotional facial and prosodic expressions will be assessed as well as production of emotional communication. The expected outcomes will be to identify and describe deficits in production and comprehension of emotional prosodic and facial expressions and to describe the relationship between deficits in emotional communication and cerebellar atrophy with magnetic resonance imaging imaging (MRI) using voxel based morphometry (VBM).
Cerebellar Diseases
The purpose of this study is to evaluate the utility of a specialized iPad application designed to treat difficulties with intonation (e.g., melody in voice) in children with autism spectrum disorders (ASD) and other communication disorders.
Autism, Communication Disorders
The primary goal of this clinical trial study is to evaluate the effect of a new therapy to improve talking in people with the language disability 'aphasia' after a stroke. The therapy is called: 'Expanding Communication and Language Generated in Conversation Treatment' (ECoLoGiC Treatment), and helps improve language skills for talking to other people in conversation. The second goal is to develop training materials to teach families of people with aphasia about the therapy and how to practice at home. This part of the study will be completed with help from two people with aphasia and a family member who have completed the program. The study asks: 1. How do people with aphasia improve their language skills following this therapy? Results will be determined by using tests of language and by testing language in conversation and other types of talking tasks, like describing a picture. 2. After completing the family training, do family members use the ideas they learned when talking to the person with aphasia? And, what do family members and people with aphasia think of the family training? The first question will be answered with a checklist to see if the family members followed the ideas they learned. The second question will be answered by talking with the people with aphasia and the family members to find out what they thought. The people with aphasia will complete language testing before and after therapy, and 6 weeks later (to see if improvements are maintained). Therapy is twice a week for one hour, for 10 weeks with a speech-language pathologist. During therapy, the person will have casual conversations with the speech-language pathologist, who will help the person communicate by giving small amounts of help at a time. The speech-language pathologist will tell the person what they are doing that does and does not help with communication. This process helps the person use more language and learn how to communicate better. The family members will have training with the speech-language pathologists to learn about the therapy and how to continue with the ideas at home. Training will take place over 3 sessions, scheduled in addition to therapy sessions. After therapy ends, the family members will have conversations with the person with aphasia, to show what they have learned. Each family member and person with aphasia will also have a 10-20 minute conversation with a researcher to share their thoughts about the training program.
Aphasia
Children with speech sound disorder show diminished accuracy and intelligibility in spoken communication and may thus be perceived as less capable or intelligent than peers, with negative consequences for both socioemotional and socioeconomic outcomes. While most speech errors resolve by the late school-age years, between 2-5% of speakers exhibit residual speech errors (RSE) that persist through adolescence or even adulthood, reflecting about 6 million cases in the US. Both affected children/families and speech-language pathologists (SLPs) have highlighted the critical need for research to identify more effective forms of treatment for children with RSE. In a series of single-case experimental studies, research has found that treatment incorporating technologically enhanced sensory feedback (visual-acoustic biofeedback, ultrasound biofeedback) can improve speech in individuals with RSE who have not responded to previous intervention. A randomized controlled trial (RCT) comparing traditional vs biofeedback-enhanced intervention is the essential next step to inform evidence-based decision-making for this prevalent population. Larger-scale research is also needed to understand heterogeneity across individuals in the magnitude of response to biofeedback treatment. The overall objective of this proposal is to conduct clinical research that will guide the evidence-based management of RSE while also providing novel insights into the sensorimotor underpinnings of speech. The central hypothesis is that biofeedback will yield greater gains in speech accuracy than traditional treatment, and that individual deficit profiles will predict relative response to visual-acoustic vs ultrasound biofeedback. This study will enroll n = 118 children who misarticulate the /r/ sound, the most common type of RSE. This first component of the study will evaluate the efficacy of biofeedback relative to traditional treatment in a well-powered randomized controlled trial. Ultrasound and visual-acoustic biofeedback, which have similar evidence bases, will be represented equally.
Speech Sound Disorder
This is a study on Internet-based video-practice speech and language therapy for persons with primary progressive aphasia (PPA), behavioral-variant frontotemporal dementia (bvFTD), or related conditions.
Primary Progressive Aphasia, Frontotemporal Dementia
The purpose of this study is to determine if transcranial direct current stimulation (tDCS) in conjunction with intensive speech therapy will improve sentence production and word retrieval in individuals with chronic post stroke aphasia.
Aphasia, Language
Participants will receive either intensive phonology or semantic feature analysis treatment for 16 weeks to improve naming, reading, and writing in individuals with chronic post-stroke aphasia.
Aphasia, Language
This is a behavioral speech therapy trial for individuals who have suffered a stroke on the left side of the brain and have difficulty speaking. The name of this disorder is called "aphasia." Individuals in this study will receive one of two treatments. The first is a phonological (sound level) treatment and the second is a semantic (word level) treatment. Individuals in both groups will receive 60 hours of therapy for free (2 hours/day, 5 days/week, 6 weeks).
Stroke
The overall objective of this study is to develop an Augmentative and Alternative Communication (AAC) system that is effective in delivering a person-centric communication device that will provide a versatile access method that can automatically learn and adapt to the user's physical abilities by creating a personalized, comprehensive keyboard interface for communication, not otherwise available to people in need of alternative communication.
Communication Disorders
Communication group intervention for individuals with Traumatic Brain Injury based on INSIGHT protocol (Keegan et al, 2020) with roll playing game focus
Communication Disorder, Social
This project will test the feasibility of developing a smart augmentative or alternative communication (AAC) system that is effective in delivering communication capabilities that automatically adapt to the users' physical abilities.
Communication Disorders
The purpose of the study is to determine if a more intensive application of communication intervention, i.e. 5 hours per week, will result in more frequent intentional communication acts, greater lexical density, and a better verbal comprehension level than children who receive the same communication intervention only one time per week.
Communication Disorders, Developmental Disabilities
Positron Emission Tomography (PET) is a technique used to investigate the functional activity of the brain. The PET technique allows doctors to study the normal biochemical and metabolic processes of the central nervous system of normal individuals and patients with neurologic illnesses without physical / structural damage to the brain. Radioactive water H215O in PET scans permits good visualization of areas of the brain related to speech. Most of the PET scan studies conducted have concentrated on learning about how language is formed and decoded. Few studies have been conducted on speech production. This study aims to use radioactive water (H215O) and Positron Emission Tomography (PET scan) to measure blood flow to different areas of the brain in order to better understand the mechanisms involved in speech motor control. When a region of the brain is active, it uses more fuel in the form of oxygen and sugar (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and water. Blood carries fuel to the brain and waste products away from the brain. As brain activity increases blood flow to and from the area of activity increases also. Knowing these facts, researchers can use radioactive chemicals (H215O) and PET scans to observe what areas of the brain are receiving more blood flow. Researchers will ask patients to perform tasks that will affect speech, voice, and language. At the same time patients will undergo a PET scan. The tasks are designed to help researchers observe the blood flow to brain areas associated with voicebox (laryngeal) functions, movement of muscles in the jaw, tongue, and mouth, and other aspects of motor speech. Special studies will be conducted to evaluate how certain therapies and tasks can draw out symptoms in illnesses in which speech and language are affected. Results of these tests will be used in other studies to evaluate the neurologic mechanisms of diseases like Tourette's syndrome and parkinson's disease.\<TAB\>
Communication Disorder, Healthy, Stuttering, Tourette Syndrome, Voice Disorder
Aphasia is a language disorder, commonly resulting from stroke or other brain injury, that impacts a person's ability to communicate. This project is looking to improve upon current treatment methods for spoken naming in people with aphasia. People with aphasia frequently report being able to successfully say a word in their head, regardless of their ability to say the word out loud. For example, when presented with a picture of a house, they may report being able to think or hear "house" in their head, even if they can't name it out loud. This "little voice" inside one's head is known as inner speech (IS). Previous research suggests that some people with aphasia can re-learn to say words with successful IS (i.e., words they can already say in their heads) easier and faster than words with unsuccessful IS. This study will extend these findings by implementing a comparative treatment study in a larger group of participants with aphasia. The results will help to establish recommendations for speech-language pathologists in choosing treatment stimuli for anomia.
Aphasia, Anomia, Language Disorders, Communication Disorders
Difficulties with speech and language are the first and most notable symptoms of primary progressive aphasia (PPA). While there is evidence that demonstrates positive effects of speech-language treatment for individuals with PPA who only speak one language (monolinguals), there is a significant need for investigating the effects of treatment that is optimized for bilingual speakers with PPA. This stage 2 efficacy clinical trial seeks to establish the effects of culturally and linguistically tailored speech-language interventions administered to bilingual individuals with PPA. The overall aim of the intervention component of this study is to establish the relationships between the bilingual experience (e.g., how often each language is used, how "strong" each language is) and treatment response of bilinguals with PPA. Specifically, the investigators will evaluate the benefits of tailored speech-language intervention administered in both languages to bilingual individuals with PPA (60 individuals will be recruited). The investigators will conduct an assessment before treatment, after treatment and at two follow-ups (6 and 12-months post-treatment) in both languages. When possible, a structural scan of the brain (magnetic resonance image) will be collected before treatment in order to identify if brain regions implicated in bilingualism are associated with response to treatment. In addition to the intervention described herein, 30 bilingual individuals with PPA will be recruited to complete behavioral cognitive-linguistic testing and will not receive intervention. Results will provide important knowledge about the neural mechanisms of language re-learning and will address how specific characteristics of bilingualism influence cognitive reserve and linguistic resilience in PPA.
Primary Progressive Aphasia, Dementia, Dementia, Frontotemporal, Alzheimer Disease, Neurodegenerative Diseases, Frontotemporal Lobar Degeneration, Apraxia, Motor, Dysarthria, Communication Disorders, Language Disorders, Speech Disorders, Neurocognitive Disorders, Aphasia, Bilingual Aphasia
Discourse impairments are breakdowns in meaningful communication beyond the level of single sentences and have a functional impact on the lives of Veterans with TBI, disrupting return to work, communication re integration, socialization, and quality of life. The few prior attempts to treat discourse impairments have been small case studies and resulted in no change or limited gains. The proposed study evaluates the feasibility of a novel narrative discourse treatment that builds upon these prior attempts by addressing breakdowns in both story content and story organization using a theoretically-driven approach. If feasible, as demonstrated by tolerability and acceptability to participants, and later shown to be effective, the proposed discourse treatment has the potential to improve daily communication, which provides a gateway for Veterans with TBI to increase meaningful participation and improve functioning in major life domains.
Traumatic Brain Injury, Neurogenic Communication Disorders
Approximately 15-20% of patients diagnosed with a concussion/mild traumatic brain injury (mTBI) have persistent symptoms that continue up to six months or longer. Typical problems identified by these patients include difficulty with memory, multi-tasking, the ability to complete tasks quickly, and higher executive functions (e.g., inhibition, initiation, insight, motivation) (Belanger \& Vanderploeg, 2005; Mott, McConnon, \& Rieger, 2012, Rabinowitz \& Levin, 2014). If these symptoms persist they can not only affect thinking, but also communication abilities (e.g., verbal and nonverbal interactions, reading, and writing) (ASHA, 2007). Therefore, it is hypothesized that screening measures that evaluate both thinking and communication can better identify individuals at-risk for persistent symptoms at two week and four weeks post-injury. Also, if cognitive-communication therapy was administered earlier post-injury, then outcomes related to return to daily activities, work, and/or the academic setting could possibly change. This study intends to investigate the use of cognitive and communication screening measures for the identification of persistent symptoms and the provision of early cognitive-communication therapy if problems persist.
Concussion, Mild Traumatic Brain Injury, Cognitive Communication Disorder
The primary objective of this study is to evaluate the efficacy and tolerability of ecopipam in reducing stuttering symptoms. It is hypothesized that ecopipam effectively reduces stuttering symptoms as measured on the SSI-IV total score, the CGI, SSS and OASES.
Stuttering, Adult, Childhood-onset Fluency Disorder, Speech Disorders, Language Disorders, Communication Disorder
The integrity of structural connectivity supporting cortical regions in the left brain hemisphere is hypothesized to enable treatment-induced naming recovery in persons with language difficulties after a stroke (aphasia). The investigators will map whole brain connectivity (i.e., the brain connectome) to investigate the role of cortical connectivity in impairment (Aim 1) and recovery (Aim 2) in patients with aphasia undergoing treatment. This information will be used to construct personalized markers of anomia treatment outcome (Aim 3), which may serve as a guide for speech-language pathologists and neurologists when facing patient management decisions.
Aphasia, Stroke, Speech Disorders, Communications Disorders
This study compares how well voice therapy works when delivered in-person versus through telehealth for older adults with age-related voice problems. Researchers are testing whether Phonation Resistance Training Exercises (PhoRTE®) can be just as effective when delivered remotely as when done face-to-face, which could make treatment more accessible and affordable for seniors. The two primary hypotheses are: 1. Does voice therapy (called PhoRTE®) work as well through video calls as it does face-to-face? 2. Can online therapy be a more accessible way for older adults to get help for their voice problems? Adults aged 55 or older with voice changes and an applicable diagnosis will be randomly assigned to receive either in-person or telehealth therapy, consisting of four 45-minute sessions. After treatment, researchers will measure improvements through: * Changes in voice function * Patient reports about their voice * Scientific measurements of voice quality * Patient satisfaction with treatment * Impact on quality of life The results will help determine if telehealth can be a good alternative to in-person voice therapy, especially important as telehealth coverage may be changing.
Atrophy of Vocal Cord, Presbyphonia, Dysphonia, Glottic Insufficiency, Voice Change, Voice Disorder, Adults, Aging, Speech Therapy, Voice Alteration
The purpose of this study is to evaluate if the effects of in-person speech-language therapy with a novel digital storybook intervention platform (Hear Me Read) improves vocabulary, speech and language, and literacy outcomes in young children who are deaf or hard of hearing compared with in-person therapy alone.
Hearing Loss, Deafness, Hearing Disorders in Children, Hearing Impaired Children, Speech Therapy, Speech Disorders in Children, Literacy
The purpose of this study is to assess subjects with muscle tension dysphonia for perceived effort and acoustic effects of gargle phonation compared to baseline and a sham water swallow.
Voice Disorders, Muscle Tension Dysphonia, Speech Therapy
Aphasia is a disorder of spoken and written language, most commonly following a stroke. It is estimated that between 2.5 and 4 million Americans are living with aphasia today. A common problem in aphasia involves difficulty retrieving known words in the course of language production and comprehension. The overarching goal of this project is to develop and test early efficacy, efficiency, and the tolerability of a lexical treatment for aphasia in multiple-session regimens that are comprised of retrieval practice, distributed practice, and training dedicated to the elicitation of correct retrievals. The aim of this work is to add to and refine the evidence base for the implementation and optimization of these elements in the treatment of production and comprehension deficits in aphasia, and make important steps towards an ultimate goal of self-administered lexical treatment grounded in retrieval practice principles (RPP) to supplement traditional speech-language therapy that is appropriate for People with Aphasia (PWA) from a broad level of severity of lexical processing deficit in naming and/or comprehension. This project cumulatively builds on prior work to develop a theory of learning for lexical processing impairment in aphasia that aims to ultimately explain why and for whom familiar lexical treatments work, and how to maximize the benefits they confer.
Aphasia
The proposed research will test the efficacy of group conversation treatment for people with aphasia and explore whether the effects of treatment differ as a result of the following factors: 1. Group size: Do large groups of 6-8 people with aphasia or dyads of 2 people with aphasia demonstrate different levels of improvement with this treatment? 2. Group composition: Do effects of conversation group treatment differ if the groups include members with similar or different types of aphasia? 3. Aphasia severity: Do effects of conversation group treatment differ if the individuals within the group have mild-moderate or moderate-severe profiles of aphasia? Treatment sessions will occur in groups of 6-8 people with aphasia or with 2 people with aphasia. During treatment sessions, discourse will be facilitated on a focused set of every day topics, such as current events or travel. Linguistic and multi modal cueing hierarchies will be tailored to individual client goals and used to maximize communication success. The prediction is that conversation treatment is an effective method for improving communication in people with aphasia, but that specific benefits may differ based on variables such as group size, group composition, and aphasia severity. The results will help inform best practices for aphasia treatment and refine a hypothesized model about the mechanisms underlying conversation treatment.
Aphasia, Acquired
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 exploratory study in adult subjects with childhood onset fluency disorder.
Childhood-Onset Fluency Disorder (Stuttering)
The purpose of this study is to evaluate how changing conditions of speech-language treatment (namely, amount of repetition and distribution of practice schedule) affects the language outcome of participants with aphasia following a stroke. Using a computer based speech and language therapy program, participants will practice conversational scripts that are either short or long. Participants will practice for either 2 weeks (5 days a week) or for 5 weeks (2 days a week).
Aphasia
The sophisticated language of science can be a barrier to Science, Technology, Engineering, and Math (STEM) learning, especially for children who have specific language impairment (SLI). The purpose of this randomized controlled trial is to test vocabulary and grammar interventions embedded in a small-group inquiry-based science instruction for their potential to ameliorate language deficits that impede science learning. Participants will be 54 preschoolers or kindergartners with SLI. Proximal and distal probes will reveal their mastery of taught and generalized language and science concepts.
Specific Language Impairment