Treatment Trials

30 Clinical Trials for Various Conditions

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taVNS for Letter Learning in Dyslexia
Description

This is a pilot study to establish feasibility of transcutaneous auricular vagus nerve stimulation (taVNS) for improving letter-learning in adolescents with dyslexia. The main goals of the study are to 1) evaluate whether children in this age range will tolerate low level stimulation over the course of multiple sessions, 2) determine whether low level taVNS improves novel letter learning in dyslexia, and 3) evaluate the effect of low level taVNS on the brain's response to letters. Participants will complete fMRI before training, immediately after training, and a few weeks after training ends. Training will consist of six 30-minute lessons during which participants will learn novel letter-sound relationships while receiving either active or sham taVNS. Researchers will compare stimulation conditions to determine effect of this device on learning and neural plasticity.

Conditions

Dyslexia

Effects of Atomoxetine on Brain Activation During Attention & Reading Tasks in Participants With ADHD & Comorbid Dyslexia
Description

This study will evaluate the effects of atomoxetine on brain activation during attention and reading tasks via functional Magnetic Resonance Imaging (fMRI) in participants ages 10 to 16 years old with ADHD and comorbid dyslexia

Conditions

Attention Deficit Hyperactivity Disorder, Dyslexia

Treatment of ADHD With Atomoxetine in Children & Adolescents With ADHD & Comorbid Dyslexia
Description

This study will evaluate the effect of atomoxetine in treating Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in children and adolescents with ADHD and comorbid reading disability (dyslexia)

Conditions

Attention Deficit Hyperactivity Disorder, Dyslexia

Comprehensive Program to Improve Reading and Writing Skills in At-Risk and Dyslexic Children
Description

This project is evaluating programs to improve reading and writing skills in children who have or are at risk for having reading disabilities. The project focuses on children who are at-risk for low achievement in school and on children with dyslexia.

Conditions

Dyslexia, Learning Disorders

Neural Mechanisms of Successful Intervention in Children With Dyslexia
Description

Dyslexia, an impairment in accurate or fluent word recognition, is the most common learning disability affecting roughly ten percent of children. This proposal capitalizes on cutting edge neuroimaging methods, in combination with reading education programs, to generate a new understanding of how successful reading education shapes the development of the brain circuits that support skilled reading. A deeper understanding of the mechanisms of successful remediation of dyslexia, and individual differences in learning, will pave the way for personalized approaches to dyslexia treatment.

Conditions

Dyslexia, Developmental

University of Washington Reading & Dyslexia Research Program
Description

Subjects are recruited for a pre-kindergarten education program focusing on early literacy skills. Primary outcomes are improvement in letter knowledge and changes in brain response to text.

Conditions

Reading Disability

Interventions for Children With Attention and Reading Disorders
Description

The objective of this randomized clinical trial is to address unanswered questions about the relative effectiveness of treatments for children with both Attention Deficit Hyperactivity Disorder (ADHD) and significant reading difficulties (RD). The study evaluates attentional and word reading outcomes for students with both conditions when provided with either (a) ADHD treatment alone, (b) RD treatment alone, or (c) the combination of ADHD and RD treatment.

Conditions

Attention Deficit Hyperactivity Disorder, Reading Disabilities

Neurobiology and Treatment of Reading Disability in NF-1
Description

The goal of this trial is to determine if children with neurofibromatosis type 1 who have reading disabilities respond the same way-both behaviorally and neurobiologically-to specialized treatment programs as children with idiopathic reading disabilities do, and to determine which intervention is best for particular learner profiles.

Conditions

Neurofibromatosis Type 1, Reading Disabilities

Using fMRI to Evaluate Instructional Programs for Children With Developmental Dyslexia
Description

Dyslexia is a common reading disorder. Specialized instructional programs can improve reading ability in children with dyslexia. This study will use functional magnetic resonance imaging (fMRI) to examine changes in the brains of children who have taken part in these programs.

Conditions

Developmental Dyslexia

Impact of Non-invasive Brain Stimulation on Learning Novel Spoken Words
Description

The purpose of the proposed study is to use transcranial magnetic stimulation (TMS) to evaluate a neurobiological model of spoken word learning in older youth. Specifically, it is hypothesized that: (1) inhibition of the left dorsal stream will impact subsequent learning, processing, and retention of phonologically similar pseudowords; (2) the impact of dorsal stream inhibition on word learning will be associated with baseline levels of variability in neural activity, indicative of underlying differences in cortical excitability.

Conditions

Dyslexia, Dyslexia, Developmental, Learning; Developmental Disorder, Reading

Eye Movements and Reading Disabilities
Description

The mechanism of the eye movement anomalies seen in dyslexic patients is not well defined. Some optometrists use observational eye movement tests as screening devices for dyslexia and advocate eye movement therapy as a treatment option for dyslexia. The reliability of the clinical eye movement tests and the efficacy of the eye movement therapies have not been determined. Saccades are the fast eye movements that move our eyes from one word to the next when we read. The eye movement recordings from patients diagnosed with reading disorders, extra ocular muscle imbalances and control patients (no learning disability or eye movement disorder) will be analyzed and compared. The sensitivity and specificity of detecting reading disorders will be determined for the Visagraph III and the Readalyzer. Although these clinical tests are frequently used to diagnose saccadic inaccuracies and diagnose dyslexia in school aged children, the validity of these clinical screening tests has not been determined.

Conditions

Reading Disability, Dyslexia

Camp SMART Speech to Print Summer Literacy Camp
Description

This project aims to explore the feasibility and efficacy of a 6-week, intensive summer literacy intervention provided to children in 1st-3rd grades.

Conditions

Reading Disorder, Developmental

The Role of Knowledge Retrieval in Inference-making
Description

This project will (a) examine the relationship between knowledge retrieval and inferencing; (b) determine the effectiveness of an intervention that improves knowledge retrieval and inferencing among struggling readers; and (c) expand research opportunities for undergraduates. The research design uses 316 struggling readers in grades 4-6 of diverse backgrounds. The effects of knowledge retrieval (accuracy and speed) on inferencing will be modeled without dichotomizing the distribution. Linear mixed effect models will be fit to determine whether reader characteristics make unique contributions to inferencing across the posttest and follow-up data collection time points. First, several structural models will be considered as students may be nested in teachers, schools, and tutors. Unconditional models will estimate the intraclass correlation for each level of the study design. If significant interclass correlations emerge, multilevel models will be fit to evaluate the effectiveness of the intervention while controlling for covariates such as pre-test performance on inference-related measures and child-attributes such as English learner status. The primary analysis plan assumes an intent-to-treat model in which the efficacy of two intact conditions will be tested. Effect sizes will be estimated to report the magnitude of difference between the two conditions. Expected outcomes include (a) the identification of a method that effectively facilitates knowledge retrieval and the application of relevant knowledge to form inferences among elementary struggling readers from diverse backgrounds; (b) the validation of an intervention that teaches struggling readers how to activate, retrieve, and interweave relevant knowledge with information in the text and accurately form inferences while reading that can be broadly implemented in general education classrooms; and (c) expansion of undergraduate research opportunities, particularly among students from diverse backgrounds who have been historically underserved.

Conditions

Reading Disability, Reading Problem

Noninvasive Brain Stimulation to Enhance Reading Comprehension Ability in Adults
Description

The goal of this project is to address the urgent need for effective, scalable adult literacy interventions by integrating breakthroughs in two separate fields: 1.) the brain network science of resilience to reading disorders and 2.) high-definition non-invasive brain network stimulation. This study will first establish the efficacy of a novel, noninvasive stimulation protocol on reading behavior and brain metrics; then will determine how stimulation-induced effects interact with baseline reading comprehension ability; and lastly, will identify whether stimulation-induced effects are more clinically-beneficial than canonical behavioral interventions. Results may change the foundation for how we treat low adult literacy, and have the potential for wider reaching impacts on non-invasive stimulation protocols for other clinical disorders.

Conditions

Reading Disability

Neurocognitive Factors in EdTech Intervention Response
Description

The current project will carry out a large-scale, randomized controlled trial (RCT) to examine the effectiveness of a home-administered technology-based treatment for reading disability (GraphoLearn) in a diagnostically diverse children with reading disability (ages 6.0-10.00). To accomplish this rapidly and with minimal cost, the experimenters will leverage the Healthy Brain Network \[HBN\], an ongoing study of mental health and learning disorders in children ages 5.0-21.0 whose family have one or more concerns about behavior and/or learning (target n = 10,000; current enrollment = 3000+). The HBN includes comprehensive psychiatric, cognitive, electroencephalogram \[EEG\] and multimodal magnetic resonance imaging \[MRI\] characterizations for all participants, providing the present work rich data to build from. The present work will recruit 450 children (ages 6.0-10.0) with reading difficulty from the HBN. In order to evaluate GraphoLearn effectiveness the experimenters will compare reading (and related language skills) before and after a 12-week GraphoLearn reading intervention relative to an active (math) control. The experimenters also assess the stability of the reading gains by including a 12 week retention period ( with pre and post retention assessment). The experimenters hypothesize that they will observe significant gains in reading (and related language) skills relative to the math control conditions, but that these gains will be variable and predicted by participant and environment level factors (predictive models are explored under Aim 2). This evaluation will involve a 3 to 4 visit between groups longitudinal study with cross over elements to evaluate GraphoLearn in struggling readers ages 6-10 using and pre-post behavioral and EEG assessment.

Conditions

Reading Disability

Building Long-term Academic Success Through Ongoing Fun Fitness Program
Description

The purpose of the research study is to investigate if daily motor activities, including fitness activities, gross motor skills, fine motor skills, and motor coordination activities result in physiological, cognitive, and behavioral benefits to children at Odyssey Academy. The study will compare students' performance after intervention by comparing an intervention period to a standard care period, and comparing intervention students to students engaged in standard school activities in the area of academic performance.

Conditions

Reading Disorder

Evidence-Based Interventions to Enhance Outcomes Among Struggling Readers
Description

Despite decades of research on reading disabilities, little is known about improving reading in the middle grades (i.e., grades 3-6) and advancements have been hindered by the narrow focus on reading problems alone without acknowledgement of non-academic factors shown to affect learning (e.g., child self-regulation). This proposal employs a highly innovative approach aimed at improving intervention outcomes through the integration of evidence-based practices for addressing reading, as well as self-regulation/socioemotional skills, difficulties known to occur in a substantial percentage of struggling readers and to negatively influence academic performance. This project represents translational research that directly informs the practice community (schools, clinicians, teachers, parents), by identifying novel instructional practices that can be aggregated to more effectively influence student outcomes and reduce disparities in academic and socioemotional domains.

Conditions

Reading Disability, Anxiety

Effects of TBS on Reading in Adult Struggling Readers
Description

The purpose of this project is to understand how reading is related to brain function. To do this, participants will perform some reading tasks and then have magnetic resonance imaging (MRI) brain scans. Participants will then receive transcranial magnetic stimulation (TMS) to the reading areas of the brain, followed by a second MRI brain scan. This will temporarily activate reading abilities. We want to better understand how the reading system in the brain functions.

Conditions

Developmental Reading Disorder, Dyslexia, Developmental

Executive Function in Early Childhood
Description

Despite the fact that a substantial number of school age children struggle with both reading and math acquisition, the brain mechanisms of the overlapping aspects of reading and math skills, thought in part to be linked via executive functions (EF), have not been unpacked. This project will use a longitudinal design, following children from Kindergarten through 1st grade, to understand how the brain networks associated with reading, math, and EF interact to predict academic outcomes and, in those who struggle academically, intervention response.

Conditions

Reading Disability

Therapy for Reading Problems in Adults After Brain Injury
Description

Adults who sustain brain damage due to stroke, head injury, or traumatic surgery may develop difficulty reading. This study examines the effectiveness of behavior-based programs to improve reading ability in these individuals.

Conditions

Dyslexia, Acquired, Brain Injuries, Cerebrovascular Accident

Efficacy of a Two-Year Intensive Reading Intervention for Middle School English Learners With Reading Difficulties
Description

This study investigates the efficacy of a reading comprehension intervention for English learners in Grades 6 and 7 with reading difficulties. Building on previous intervention studies conducted with students in Grades 4 through 8 over the past 10 years, the investigators utilize a longitudinal, double-cohort design utilizing a randomized control trial assigning students to supplemental reading intervention (RISE) or a no intervention "business as usual" (BAU) comparison condition (i.e., Cohort 1 - Years 1 and 2; 205 students in treatment and 205 in control condition; Cohort 2 - Years 3 and 4; 205 students in treatment and 205 in control condition; total 410 in each condition). Students in each cohort will be treated for 2 years (i.e., 6th and 7th grades or 7th and 8th grades). The primary outcome is reading comprehension. The investigators hypothesize that participants receiving the RISE intervention will outperform those receiving BAU instruction across reading-related elements, including word reading, fluency, and comprehension at end of year two of treatment.

Conditions

Learning Disorders, Dyslexia

My Scrivener® - Measuring Effectiveness and Dose Response in Children
Description

This study will assess whether a computer haptic peripheral device programmed to provide repetitive motion training is as effective as the same repetitive motion training provided by a human being.

Conditions

Asperger's Syndrome, Dyslexia, Cerebral Palsy, Attention Deficit Disorder, ADHD, Traumatic Brain Injury, Stroke

Multimodal Treatment of Phonological Alexia: Behavioral & fMRI Outcomes
Description

This study offers 90-120 hours of 1:1 training to improve reading skills in adults who have poor reading skills following a stroke. Specifically, this study is designed to improve skill in sounding out words for reading and spelling. The overall time commitment for participation in this study is approximately 11-30 weeks.

Conditions

Aphasia, Stroke, Dyslexia, Acquired

Combined Exercise and Targeted Therapy for Post-Stroke Reading Deficits
Description

The goal of the proposed project is to test the effectiveness of a novel hybrid approach to treatment of reading disorders after stroke, in which exercise training will be used in combination with a targeted reading treatment. This approach is expected to increase cerebral circulation and help to rebuild and strengthen the damaged phonological neural networks. Through this combinatory approach, the study aims to enhance the reading and language improvements seen with existing treatments.

Conditions

Stroke, Aphasia, Reading Disorder

Neurofeedback Intervention for Reading Deficits in Subacute Stroke
Description

The overall goal of this project is to advance a biologically-based approach to treatment of reading disorders after stroke, which will expand the limits of cognitive rehabilitation. Using a novel brain imaging technique, called real-time functional magnetic resonance imaging (fMRI) neurofeedback combined with right hand motor imagery, this project will re-instate brain activity in the left language-dominant hemisphere. Stroke patients will practice modulating their own brain activity using fMRI neurofeedback signal and will select the most effective mental strategies that help them maintain brain activation patterns associated with better reading recovery.

Conditions

Stroke, Dyslexia, Acquired

Reading Remediation and Outcomes in Detention
Description

The current literature on academic skill difficulties, whether considered as part of the continuum of ability or as a specific learning disability (LD), indicates that these problems often coexist with conduct problems and juvenile delinquency, and are risk factors for initial law-breaking behavior and for its persistence. However, less is understood about how this relationship develops. It is these broad questions that this project seeks to address. First, what is the causal pathway? Does LD cause delinquency, delinquency cause LD, or are both caused by something else? And can big data analytics applied to statewide datasets of information about juvenile justice (JJ) involvement help to answer this question? Second, as it is known that learning to read and do math (and thus becoming more employable) increases the likelihood of desistance (i.e., not committing any more illegal acts), what are the necessary parts of an intervention designed to teach these skills? And what role might technology play in such an intervention? To answer these questions, we will implement a study that includes two components, (a) a big data component and (b) an intervention component. For (a), we will work with a large historical dataset from the Harris County Juvenile Probation Department. For (b), we will work, in total, with 192 (48 per year) delinquent youth with severe LD in residential placement. These individuals, in a nonconcurrent multiple baseline design, will be offered an educational therapy designed to address severe reading problems in juvenile detainees using a novel mixed media intervention in which the person-to-person intensive 1:1 component is completed while youth are in residential settings (24 sessions, delivered in 90 minute settings 3 times a week) and a "gamified" educational smartphone learning tool follow-up completed upon release (with appropriate network fidelity monitoring and participant reinforcement). The person-to-person component is developed specifically for juvenile offenders with severe LD, combining two well-established and highly-regarded intervention programs designed to systematically build students' repertoire of grapheme-phoneme correspondence rules as well as develop comprehensive reading skills, from beginning reading to proficiency.

Conditions

Specific Learning Disorder (MeSH Unique ID: D000067559), Dyslexia (MeSH Unique ID: D004410), Conduct Disorder (MeSH Unique ID: D019955)

Interventions for Reading Disabilities in NF1
Description

Neurofibromatosis Type 1 (NF1) is a common genetic disorder that is associated with a four times greater risk of learning disabilities, including reading disabilities, and a deficiency of neurofibromin - a protein important in a signaling pathway that regulates learning and memory. Our previous work (NS49096) demonstrated that school-age children with NF+RD can respond to standard phonologically-based reading tutoring originally developed to treat reading disability in the general population. Combining our work with that by other researchers suggesting that a medication (Lovastatin) may counteract the effects of the deficient neurofibromin, and possibly ameliorate learning disabilities in NF1, the investigator propose to examine the synergistic effects of medication plus reading tutoring.

Conditions

Neurofibromatosis Type 1, Learning Disability, Reading Disability, NF1

Treatment With Atomoxetine Hydrochloride in Children and Adolescents With ADHD
Description

The purpose of this study is to assess the efficacy and safety of atomoxetine administered once daily in the treatment of children and adolescents with ADHD and comorbid dyslexia.

Conditions

Attention-Deficit/Hyperactivity Disorder, Comorbid Dyslexia

Let's Know!2: Language-focused Intervention for Children at Risk of Comprehension Difficulties
Description

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.

Conditions

Language Disorders in Children

Reading in Preterm and Full-term Children: Neural Basis and Prediction
Description

The purpose of this study is to understand reading abilities of children born preterm: their cognitive profiles, the neural basis of good and poor reading abilities, and the behavioral and neural factors that predict persistent difficulties. The investigators hope to learn * what specific skills correlate reading skills * if preterm children have different cognitive profiles than full term children with respect to reading * if cognitive skills measured in kindergarten predict reading ability in the second grade * if parts of the brain are associated with reading skill * whether brain characteristics in kindergarten predict reading in second grade.

Conditions

Premature Birth, Basic Learning Problem in Reading, Child