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NCT04060017
The primary objective of this study is to evaluate the cognitive and behavioral effects of liquid leucovorin calcium on young children with autism spectrum disorder (ASD) and determine whether it improves language as well as the core and associated symptoms of ASD. The investigators will enroll 80 children across two sites, between the ages of 2.5 and 5 years, with confirmed ASD and known language delays or impairments. Participation will last approximately 26 weeks from screening to end of treatment.
NCT06250101
This study will enroll children between the ages of 4 and 6 years of age who exhibit significant difficulty developing language skills without any other handicapping conditions. Children will receive standardized language, hearing, and cognitive testing to confirm a diagnosis of developmental language disorder. Children will be enrolled in a half-day summer camp program for six weeks during which they will receive treatment designed to improve their language skills. Children will be seen again approximately six weeks after the end of treatment to determine how much learning they have retained.
NCT05283265
First, in a recording-only self-paced reading experiment, patients with epilepsy undergoing intracranial monitoring for clinical purposes will read or listen to sentences presented to them one word at time while the investigators simultaneously record neural activity through intracranial electrodes that are implanted for clinical purposes (see subject populations). At the end of the sentence, the subjects have to indicate how they comprehended the sentence by selecting which of several pictures matches the sentence they just read. Behavioral measures that the investigators record and analyze are their response times to advance to each next word in the sentence, and which picture they chose for each sentence. These behavioral measures are compared against the neural activity simultaneously recorded as they are made. Then, in a later session, the same participants will participate in a task-related stimulation experiment. This follows the exact same design as the recording-only reading experiment, the only difference is that on some trials, at controlled moments during the sentence presentation intracranial electrical stimulation is delivered through adjacent intracranial electrode contacts. The investigators will examine the effect of this stimulation on the subjects comprehension of the sentences measured by their behavior, and on the simultaneously recorded neural activity.
NCT07369960
This study explores a safe and effective new approach to improve language function in children with Global Developmental Delay (GDD). Conducted at Xiangxi Autonomous Prefecture People's Hospital, the study will recruit approximately 50 children aged 2 to 5 years. Participants will be randomly assigned to one of two groups: one receiving personalized language training combined with non-invasive, painless repetitive Transcranial Magnetic Stimulation (rTMS) to activate language regions of the brain, and a control group receiving personalized training alongside sham stimulation for comparative analysis. The study spans one month, including a two-week intervention period followed by a two-week follow-up to evaluate the efficacy and sustainability of the combined therapy. This study has been rigorously reviewed and approved by the hospital's Ethics Committee.
NCT03838016
A critical knowledge gap is whether proactive intervention can improve speech and language outcomes in infants at known risk for communication disorders. Speech and language assessments and treatments are usually not initiated until deficits can be diagnosed, no earlier than age 2-3 years. Preventive services are not available. Children with classic galactosemia (CG) hold the keys towards investigating whether proactive services are more effective than conventional management. CG is a recessively inherited inborn error of metabolism characterized by defective conversion of galactose. Despite early detection and strict adherence to lactose-restricted diets, children with CG are at very high risk not only for motor and learning disabilities but also for severe speech sound disorder and language impairment. Delays are evident from earliest signals of communication and persist into adulthood in many cases but speech/language assessment and treatment are usually not initiated until deficits manifest. However, because CG is diagnosed via newborn screening, the known genotype-phenotype association can be leveraged to investigate the efficacy of proactive interventions during the acquisition of prespeech (2 to 12 months) and early communication skills (13 to 24 months). If this proactive intervention is more effective than standard care regarding speech and language outcomes in children with CG, this will change their clinical management from deficit-based to proactive services. It will also motivate investigating this approach in infants with other types of known risk factors, e.g., various genetic causes and very low birth weight. The Babble Boot Camp is a program for children with CG, ages 2 to 24 months. The intervention is implemented by a pediatric speech-language pathologist (SLP) via parent training. Activities and routines are designed to foster earliest signals of communication, increase coo and babble behaviors, support the emergence of first words and word combinations, and expand syntactic complexity. The SLP meets with parents online every week for 10 to 15 minutes to provide instruction, feedback, and guidance. Close monitoring of progress is achieved via regularly administered questionnaires, a monthly day-long audio recording, and the SLPs weekly progress notes. At age 24 months, the active phase of the Babble Boot Camp ends. The children receive a professional speech/language assessment at ages 2 1/2, 3 1/2, and 4 1/2 years.
NCT05133479
In the proposed project, the investigators will conduct a multisite randomized controlled trial (RCT) to determine the efficacy of Let's Know!2, a small-group, language focused comprehension intervention, on children's lower- and higher-level language skills and comprehension skills in the short- and long-term (Specific Aims 1 and 2). The investigators will also explore whether intervention effects are moderated by dosage, initial language skill, developmental language disorder (DLD) status, word reading skill, nonverbal IQ, and family socioeconomic status (Specific Aim 3). Children who have low language skills and are thus at risk for reading comprehension difficulties will participate in the study. Children will be randomly assigned to receive Let's Know! in small groups at their respective schools or to a business-as-usual control condition. The investigators will measure children's language and comprehension skills at the beginning and end of Grade 1 as well as in Grade 2 and Grade 3. The investigators hypothesize that children who experience Let's Know! will end Grade 1 with higher language skills than children in the control condition and that this will translate into better listening and reading comprehension skills as these children matriculate through elementary school.
NCT05741853
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.
NCT05443633
Aphasia is an acquired impairment of language, that commonly results from damage to language areas in the brain (typically the left side of the brain). This impairment is seen in many aspects of language, including understanding, speaking, reading and writing. It is estimated that about 2 million individuals are currently living with aphasia in the United States. Further, about 200,000 Americans acquire aphasia every year (National Aphasia Association, 2020). Aphasia poses significant impact on the affected individuals and their families. Behavioral treatments that target language deficits have been shown to enhance overall communication skills and life satisfaction among individuals with aphasia. Although there is evidence that suggests that treatment is efficacious for individuals with aphasia, the extent of improvement long-term coupled with the neural patterns among those individuals are largely unknown. The current study aims to investigate the efficacy of language-based treatment and its corresponding neural patterns.
NCT06633874
This clinical trial aims to justify a protocol for designing and developing an automated decision-making system to support and enhance screening and early detection procedures for developmental speech/language difficulties in child communication. The system will utilize smart computing models, sensors, and early diagnostic speech and language deficiency indicators. The study participants will be typically and non-typically (neurodevelopmentally atypical) developing children, primarily in preschool and elementary school. The key research questions the study seeks to address are: 1. Do differences exist between typically developing and neurodevelopmentally atypical children when engaging with the serious game used in the study? 2. If such differences are identified, can the collected data be utilized to train an automated decision-making system capable of accurately distinguishing between typically and neurodevelopmentally atypical children based on speech and language deficiencies? Researchers will compare typically and non-typically developed children to see if the system can incorporate multiple data points from assessment domains to create a diagnostic profile. After the parents are informed of the study and provide written consent, they enroll in the system. Participants will be asked to wear a smartwatch and play a serious game on a tablet under the supervision of a clinician. The system will collect data from the gameplay and sensors.
NCT04762043
This study will evaluate the ability of MyoVoice to replace natural speech. Referred to generally as an Augmentative and Alternative Communication (AAC) device, MyoVoice uses electrical signals recorded non-invasively from speech muscles (electromyographic, or EMG, signals) to restore communication for those with vocal impairments that resulted from surgical treatment of laryngeal and oropharyngeal cancers.
NCT06025890
Diagnosis of Language Disorder and Attention Deficit Hyperactivity Disorder (ADHD) is difficult for several reasons. This study aims to establish a Chinese multi-center cohort for the early diagnosis of language disorder and ADHD in children, develop appropriate early assessment tools and formulate intervention programs and standards for early functional training. Based on a national multi-center research team with Chongqing, Shanghai, and Beijing as the core areas, the investigators established a specific disease cohort for early diagnosis of language disorder and ADHD: a specific disease cohort with language disorder (900 cases) who were 1-3 years when the follow-up started, and 4-6 years old at the end of follow-up; a specific cohort with ADHD (1200 cases) who were 3-6 years when the follow-up started, and 7-9 years old at the end of follow-up. At the time of enrollment, professional assessments such as clinical development indicators and neurological function indicators were assessed using functional near-infrared spectroscopy(fNIRS). Outcome measures were speech impairment and hyperactivity. Blood samples were taken from 600 speech-impaired patients and 800 ADHD patients. Of these, 800 ADHD subjects completed an fNIRS imaging task. Build an intelligent brain image big data analysis system to realize early quality control, processing, and analysis of brain images, and study objective markers for early disease detection. The investigators can use machine learning and applications for early diagnosis, developing big data analysis tools such as integrated clinical assessment and brain imaging, promoting comprehensive clinical assessment and big data analysis tools systems such as brain imaging, and building assessment tools for language disorders and ADHD. Through the implementation and results of the multi-center special disease cohort platform, evidence-based medical evidence is collected to form clinical standards and guidelines.
NCT05487521
In general, the severity of the patients' language disorders fluctuated with the degree of EEG epileptiform activity . Since then, a spectrum of disorders, often referred to collectively as the epilepsy-aphasia spectrum, have been described that share features of sleep potentiated EEG abnormalities, cognitive problems, and rare or even absent clinical seizures . In our study , Investigators evaluated the sleep EEG changes in pediatrics with languague dysfunction then in patients with EEG changes , investigators gave treatment according to type of EEG changes and investigators did a follow up assessment of language , EEG changes and frequency of clinical seizures if present at first .
NCT04204356
Aphasia is a language impairment caused by brain injury such as stroke that affects the ability to understand and express language, read and write due to damage in the language regions of the brain. Non-invasive brain stimulation (NIBS) techniques like transcranial direct-current stimulation (tDCS) have been found to improve aphasia treatment effects in post stroke patient populations such as improved naming abilities. However, the effect of tDCS on more functional, higher level language skills such as discourse production (i.e. story telling, giving instructions) has yet to be understood.Therefore the aim of this study is to determine the potential effectiveness of tDCS as an adjunct to speech and language therapy (SLT) to improve discourse speech production in people with post-stroke aphasia. It is hypothesised that SLT combined with tDCS will result in greater improvements in discourse language production compared to SLT on its own.
NCT04505696
There has been limited research in the area of speech and language therapy awareness in Pakistan. The study aims to assess the efficacy of providing speech therapy awareness in private schools through a pre-post model. This Quasi experimental study will be a means of reaching out to schools and directly create awareness regarding the field and its scope. Pre-assessment will be carried out and after which a 45 minutes presentation will be conducted face to face or through a webinar as per school directives. The results will be analysed quantitatively and pre-post assessment of the participants will be measured.
NCT04253600
For most children, language acquisition might appear like an effortless phenomenon, mostly arising from informal daily interaction with their surrounding people. Despite an adequate learning environment however, some children encounter major difficulties in learning their native tongue and develop a Developmental Language Disorder (DLD). Although the existence of a multi-factorial etiology has seemed to reach an agreement, presumably combining genetic and environmental factors to some kind of neural disruption, the underlying mechanisms leading to DLD are, to date, poorly understood. Many studies have attempted to identify risk factors and early predictors associated with the future development of a language impairment. However, despite the constant efforts to identify early markers able to differentiate between transient and persistent language difficulties, early detection of children who will be developing a DLD remains highly difficult, partially due to the lack of direct and ecological measures of early language and communication development. In addition research on the causal neural correlates of DLD is in its infancy, and often compromised by small sample sizes or analyses methods that lack anatomical specificity to determine the neural correlates of language impairment. Hence, In order to improve early detection and, therefore, language intervention, this longitudinal research project aims at investigating the early predictive factors as well as the neurocognitive basis of DLD by means of an integrative, multi-dimensional, and multi-methodological approach. To substantially gain insight, this research ideally integrates risk factors at multiple different levels, including the cognitive, neurobiological, parental and environmental level. From a methodological perspective, we will combine direct and indirect behavioral methods with neuroimaging methods in order to propose an early predictive model of language development.
NCT00125242
The purpose of this investigation is to further develop and test a treatment for word-finding problems in aphasia. The treatment is designed to strengthen meaning associations within categories of words (e.g., animals, tools, fruits). The treatment is also designed to be used as a search strategy in instances of word-finding difficulty. The study was devised to evaluate the extent to which treatment increases the ability to recall trained, as well as untrained, words.
NCT00625261
The purpose of the study is to examine the effectiveness of a highly-structured parent-based language intervention group program for two-year-old children with language delay.
NCT00033150
Brief Summary: Nearly 7% of elementary school children present with difficulties learning and using language. Unfortunately, language impairments are often long lasting and may have serious social, academic, and vocational ramifications. More than 1 million children receive language intervention in the public schools each year, and many more are seen in hospitals and other clinical settings. This randomized clinical trial compares the language outcomes of Fast ForWord to two other interventions (computer assisted language intervention without acoustically modified speech and individual language intervention) and to the outcomes of an academic enrichment (control) condition. Each year for 3 years, children will be randomly assigned to each of the four conditions at three regional sites (Austin, Texas, Dallas, Texas, and Lawrence, Kansas). The treatments will be administered in special summer programs. The primary research question is which intervention results in the most improvement in the composite language score from the Oral and Written Language Scales. Secondary questions include which intervention results in the greatest gains in conversational language,which intervention results in the greatest gains 3 and 6 months after training, which intervention results in the greatest improvement in auditory perception, and which intervention is the most cost effective. The results of the study will have theoretical and practical value. Theoretically, the study tests the temporal processing hypothesis of language impairment. Practically, the study will describe and compare the language, communication, auditory processing and academic outcomes of different language interventions. The study will help clinicians and administrators choose the most effective and least expensive treatment for the children they serve.