59 Clinical Trials for Various Conditions
Individuals with stroke commonly experience both depression and cognitive difficulties. The goal of this study is to evaluate the efficacy of a treatment that combines a digital therapeutic (an iPad-based cognitive training program) with learning cognitive strategies. The hypotheses are that this treatment will improve cognitive skills, depression symptoms, daily function, and brain connectivity. In the short-term, the findings will inform the efficacy of the intervention and in the long-term, may support the use of the intervention to improve co-occurring cognitive and mood difficulties after stroke.
Although there are an increasing number of mental health treatment adaptations for older adults, there are still a number of factors to consider when making these adaptations. Cognitive decline is one such factor that places significant burden on older adults and can interfere with traditional mental health therapies. Engage is a behavioral treatment approach that has shown to be effective in treating late life depression. The investigators are testing the feasibility of Engage as a treatment method for late life depression in older adults with cognitive decline. The objective is to corroborate Engage as an alternative late life depression treatment method for a sub-population of older adults with cognitive decline. Cognitive decline poses a unique mental health treatment barrier that is often over looked in younger populations. With a relatively higher prevalence of cognitive decline in older adulthood, it is imperative that a feasible mental health treatment program that can be effective in the presence of cognitive decline.
Many Service members (SM) experience executive dysfunction associated with mild traumatic brain injury symptom complex (mTBI-sc), for which they receive cognitive rehabilitation. Cognitive rehabilitation (CR) for executive dysfunction often involves metacognitive strategy instruction (MSI) to help patients self-regulate their behavior though a goal management process - identifying a goal, anticipating performance problems, generating possible solutions, self-monitoring performance during the activity, recognizing maladaptive task strategies, stopping and then modifying real-time task behavior by choosing an alternate strategy. MSI alone often does not result in improved daily functioning because it requires conscious cognitive oversight to employ (which is difficult for people with executive dysfunction) and it presumes that simply establishing goals propels goal-directed action, when for many people, this is not so. Social psychologists report that people who set implementation intentions (if-then statements that link specific situational cues with specific goal actions) are more likely to perform goal actions than those who only set goal intentions. Implementation intentions are believed to be effective because they enable people to switch from conscious-effortful reflective action control to automatic, reflexive action control associated with selected situational cues. A team of researchers from the Courage Kenny Research Center (CKRC), Traumatic Brain Injury Center at Fort Campbell, KY (TBIC-FC), and Neurofunctional Research and Consulting has developed a brief CR intervention to teach SM with mTBI-sc to set implementation intentions called ACTION (AutomatiC iniTiation of IntentiONs) sequence training. The purpose of this pilot study to evaluate: 1) the practicality of instructional methods used to teach SM with mTBI-sc to perform the ACTION sequence and 2) the efficacy of ACTION sequence training in achieving personal goals and performance on a task that challenges executive function using a small randomized controlled trial. If the results are positive, a larger study would be conducted to determine the impact of ACTION sequence training on SM performance on military-relevant tasks and goals.
A common and potentially debilitating late effect of childhood cancer treatment is neurocognitive impairment, frequently in the domain of executive dysfunction, which can limit educational attainment, employment, and quality of life. Among the survivors of childhood acute lymphoblastic leukemia (ALL) in the SJLIFE cohort, the frequency of executive function impairment has been shown as high as 58.8%, with moderate to severe impairment as high as 33.5%, and risk for impairment increased with time from diagnosis. Given the potential of pervasive impact of neurocognitive impairment on daily life, interventions directed at reducing neurocognitive dysfunction among childhood cancer survivors with long-term follow-up are needed. This study examines the potential feasibility and efficacy of a novel intervention to improve executive function. Primary Objectives: * To evaluate the feasibility of a home-based intervention using Transcranial Direct Current Stimulation (tDCS) and cognitive training in adult survivors of childhood ALL participating in the SJLIFE protocol at St. Jude Children's Research Hospital (SJCRH). Secondary Objectives: * To estimate the efficacy of a tDCS intervention paired with cognitive training. * To explore the short-term effect of tDCS on measures of executive function among adult survivors of childhood ALL participating in the SJLIFE protocol
This is a 12-week clinical trial evaluating the efficacy and safety of memantine hydrochloride (Namenda) in the treatment of executive function deficits (EFDs) in adults with Attention Deficit Hyperactivity Disorder (ADHD) receiving open-label treatment with OROS-Methylphenidate (OROS-MPH, Concerta). The study aims to examine the effects of treatment with memantine on ADHD symptoms. Following screening procedures, memantine is prescribed in randomized, double-blind fashion (equal chance of medication or placebo) for 12 weeks, along with open-label OROS-MPH (everyone receives medication).
1. To determine whether tasks taken from the field of cognitive neuroscience can detect and distinguish impairments in executive function above and beyond standard neuropsychological measures in individuals with: a.) Mild Traumatic Brain Injury (TBI), b.) Post Traumatic Stress Disorder (PTSD), c.)Mild TBI+PTSD 2. To determine whether performance on these tasks is linked to pertinent psychiatric outcomes (e.g. history of suicidality), which is associated with compromised executive function and impulsivity. 3. To determine whether information regarding brain anatomy can provide additional information above and beyond behavior performance in distinguishing between these two groups.
Those with traumatic brain injury (TBI) are at increased risk for suicidal behavior, and suicidality is associated with executive dysfunction. In the aim of highlighting an important risk factor, this study will assess decision making in the context of an interaction between suicide and TBI. Findings will also allow for exploratory analyses aimed at identifying associations between performance on measures of executive functioning and psychological distress. The long-term objective of this study is to increase understanding regarding executive dysfunction, as a multidimensional construct, with the ultimate goal of conceptualizing assessment tools and interventions aimed at decreasing suicidality in the at-risk population of veterans with a history of TBI.
The overall purpose of this research is to learn how Parkinson's disease affects thinking and memory in everyday life. Participation will involve thinking tests, questionnaires and interviews about thinking and activities in everyday life.
Atomoxetine (Strattera) is a drug that is currently approved for treatment of attention deficit hyperactivity disorder (ADHD) in children and adults. Atomoxetine works to enhance levels of brain chemicals that may be affected in people with executive dysfunction, (difficulties with organization, task completion, and priority setting). Thus, atomoxetine has the potential to improve executive dysfunction in people with Parkinson's disease (PD). The goal of this study is to provide preliminary data on the effectiveness and tolerability of atomoxetine for the treatment of executive dysfunction in patients with PD.
Working memory (WM) is the ability to hold relevant information in mind in the absence of sensory input. The capacity for WM is a foundation for cognitive control and higher cognitive function more broadly. Previous research demonstrated that during the delay period of WM tasks, oscillatory electrical activity in the prefrontal cortex in the theta-frequency band (4-8 Hz) increased in amplitude. However, other groups found that the slope of the aperiodic signal in the brain was positively correlated with individual differences in WM capacity. Since low-frequency power and a steeper slope of the aperiodic signal are confounded in many analyses, it is not clear whether the slope of the aperiodic signal or the amplitude of low-frequency oscillations underlie WM capacity. With many studies investigating the causal role of theta oscillations in WM, the purpose of this project is to investigate the role of the aperiodic signal in WM performance.
Executive function (EF) skills are a set of essential cognitive abilities that enable individuals to demonstrate their knowledge and talents, effectively complete tasks and navigate social interactions through flexible regulation of their thinking, behavior and emotions. EF is strongly linked to academic readiness and long-term educational outcomes. Children's EF is impacted by poverty-related experiences and is also impaired in the increasing number of children with developmental and emotional disabilities. Interventions targeting EF skills hold particular promise for improving children's educational trajectories by leveraging brain plasticity in the preschool period. We will directly target EF skills in preschoolers with poor EF. This project will address a key source of the achievement gap by meeting the needs of children at the highest risk, those who: 1) show early signs of EF impairment; 2) live in low-income communities and 3) are at risk for developmental and emotional disabilities (DD/ED). The intervention is a downward extension of Unstuck and On Target for elementary school (UOT; Cannon, Kenworthy, Alexander, Werner, \& Anthony, 2018), an EF intervention shown to be effective at increasing children's learning behaviors, as delivered by school staff. The research team will partner with key stakeholders to revise and iteratively refine UOT-P through a development trial, utilizing participant, teacher and parent feedback. The results of this trial will be leveraged to enable the team to apply for future federal funding for a randomized comparative effectiveness trial (NIH, Institute of Educational Sciences, Patient-Centered Outcomes Research Institute).
This project explores the association between learning and cognitive flexibility by testing whether a cognitive behavioral intervention designed to improve flexibility in ASD changes learning and associated neural activation using model-based functional magnetic resonance imaging (m-fMRI). The study proposes that variability in learning mechanisms is associated with behavioral flexibility and explains differences in adaptive and treatment outcomes. The study employs a longitudinal case-controlled design in 60 14-18 year old youth with ASD at 3 time-points 8 months apart, each including m-fMRI during learning and behavioral measurement of executive and adaptive function. Aim 1 tests the hypothesis that individual variation in learning biases and their neural correlates predicts behavioral flexibility and is stable over time. Aim 2 tests plasticity of learning mechanisms induced by a cognitive-behavioral intervention for flexibility. Aim 3 tests hypothesis about intervention-induced plasticity of neural functional connectivity.
This study will test the effectiveness of a school-based cognitive behavioral executive function (EF) intervention, Unstuck \& On Target High School (UOT:HS), for transition-age youth with autism spectrum disorder (ASD). UOT:HS was designed to be embedded in high schools and delivered by school staff to improve generalization of skills, increase access to mental health care, and fill a gap in evidence-based approaches to support postsecondary transition. UOT:HS targets flexibility and planning skills and focuses on key functions needed for adult success across 25, 1-hour lessons. School staff will be trained to deliver UOT:HS, study staff will provide ongoing check-ins, and parents will be offered home extensions for each lesson and two trainings to generalize skills to the home environment. Behavioral and parent-report data will be collected prior to intervention, post-intervention, and at 4-to-6-month follow-up.
This is a randomized, controlled pilot study to evaluate the efficacy of "ASCEND-I" (A Strategy and Computer-based intervention to ENhance Daily cognitive functioning after stroke - Inpatient), an inpatient intervention that combines computer-based cognitive training and coaching of cognitive strategies to improve working memory (WM) and related executive functions in individuals with stroke. The investigators hypothesize that relative to an "enhanced usual care" control condition, ASCEND will be associated with improvements in WM. The investigators also hypothesize that measures of baseline brain connectivity (assessed via participants' routine clinical magnetic resonance imaging scans) will predict response to ASCEND-I.
The purpose of this current study is to conduct a conceptual replication with an independent evaluation team of the randomized controlled trial conducted by Langberg and colleagues, which demonstrated the efficacy of the Homework, Organization, and Planning Skills (HOPS) intervention. The study will be conducted under routine practice conditions with school staff serving as interventionists; the study sample will include the broad range of students with organization, time management, and planning problems. The study will examine how implementation factors (fidelity, engagement, working alliance) are related to outcomes, and it will explore the potential moderating role of school organization factors on outcomes.
The purpose of this research study is to establish if a novel high-speed yoga program which incorporates visual cues can make a positive change in the participant's ability to make decisions and move as measured by several cognitive, balance and functional tests. It has been shown that yoga can improve balance and movement in those diagnosed with Parkinson's disease.
Transcranial magnetic stimulation (TMS) is a neuromodulation device that is FDA-approved for use in treating depression and obsessive compulsive disorder. TMS works by applying a safe, electromagnetic field on the scalp, which can either increase or decrease neuronal communication and activity (depending on the mode of stimulation). Although it is only approved for two disorders, there has been substantial research into the potential of TMS to treat a wide range of neuropsychiatric disorders, including substance use disorders (SUDs). This project aims to develop an initial TMS protocol in a sample of healthy controls and to establish the feasibility and efficacy of using repetitive TMS (rTMS) to impact several carefully-selected cognitive, behavioral, and physiologic measures. This pilot project will enable the research team to gather baseline data using this new method and to plan longer-term programmatic studies focusing on populations with SUDs. The overarching aim of this project is to develop an rTMS protocol for use in the human laboratory setting with both healthy controls and individuals with SUDs. The investigators also hope to learn about the impact of high frequency rTMS over the DLPFC on multiple aspects of functioning including: cognitive control, impulsivity, thermal pain sensitivity, motivation, and mood.
Executive function deficits are common in late life depression (LLD) and are associated with resistance to antidepressants, poor quality of life, considerable disability and increased suicidal risk. This study uses a novel type of Transcranial Magnetic Stimulation called intermittent Theta Burst Stimulation (iTBS). iTBS delivers high frequency (50Hz) magnetic pulses in "bursts" of 3 stimuli. It is posited that this intervention induces plasticity in the human cortex. Theoretical and empirical evidence from research studies informs that iTBS can improve depression and executive deficits, however, this has not been examined in older adults. This project examines iTBS's ability to improve depression and executive impairment in LLD. It also tests the effects of iTBS on brain connectivity within the Cognitive Control Network (CCN). This study will enhance understanding of LLD, providing critical pilot data to develop future randomized controlled clinical trials. Both active and sham interventions are administered sequentially to the left and right dorso-lateral prefrontal cortex. The total stimulation time is about 7 minutes. These interventions are administered for 6 weeks (Monday-Friday). 20 subjects will be randomized. Changes in mood from baseline to the end of study are measured with the Montgomery-Asberg Depression Rating Scale. Executive function at baseline and end of study are evaluated with the National Institutes of Health Toolbox executive domain battery. Safety assessments include: the 21 item Scale for suicidal ideation SSI. The frequency, intensity and burden of side effects rating (FIBSER) and the Altman Self Rating Mania scale (ASRM). Ancillary depression measures include the Quick Inventory of Depressive Symptoms (QIDS) and the Clinical Global Impression of Improvement scale. Subjects undergo functional Magnetic Resonance Imaging (fMRI) before and after the study interventions to test the effects of iTBS on the brain's functional connectivity. This research will provide meaningful information about the effects of iTBS on mood and executive function in older adults as well as information regarding its effects on brain function. Results of this pilot study will inform a grant submission and allow investigators to calculate power for a definitive randomized controlled clinical trial to test the efficacy of iTBS versus placebo.
Lack of adherence to an exercise program is a major problem for older Veterans. Several fall prevention programs fail in the home setting due to lack of adherence. Exercise adherence is dependent on brain function among other factors. Magnetic stimulation of the front part of the brain improves brain function necessary for planning and following-through. The investigators propose a three-phase study in 106 sedentary older Veterans. Everyone will be trained on use of the exergame, Nintendo Wii-Fit, that the investigators' team has found beneficial in improving balance and gait. They will be asked to exercise using Wii-Fit at home for 45 minutes daily five days/week for 12-weeks. Those that exercise less than recommended dose and those that exercise adequately but have low executive function will receive either real or sham magnetic stimulation to the front part of their brain over ten sessions paired with exercise training. All subjects will further complete 24-weeks of Wii-Fit home exercises. Adherence, executive function, balance and gait, self-efficacy, delay discounting, and falls will be measured periodically.
This project will develop and evaluate the initial effectiveness of an intervention training executive functioning, metacognition, and self-regulation in preschoolers attending certain high poverty Cincinnati preschools. Studies show that these skills are critical for school performance, and that children with better executive functioning have better long term outcomes. It is also important to intervene early when children are most likely to profit because their brains are rapidly developing. There are some promising programs targeting these skills in preschoolers, but few are available to teachers for implementation in the classroom setting. The specific aims of this study are: 1) to adapt a promising clinic-based program for the preschool classroom environment, and 2) to test the feasibility and initial impact of the adapted program on executive functioning and school readiness in schools with a high proportion of children from low income families.
The goal of this multi-site clinical trial is to determine the effectiveness of two components of a web-based intervention (Epilepsy Journey) to improve executive functioning in adolescents with epilepsy. The two components include web-based modules and problem-solving telehealth sessions with a therapist focused on executive functioning. This trial aims to answer the following questions: 1. Which components of Epilepsy Journey (web-based modules or telehealth sessions with a therapist) are essential for improving executive functioning in adolescents with epilepsy? 2. Which components of Epilepsy Journey (web-based modules or telehealth sessions with a therapist) are essential for improving quality of life in adolescents with epilepsy? Participants will be randomly assigned to one of four groups: 1) Epilepsy Journey web-based modules and telehealth sessions, 2) Epilepsy Journey web-based modules only, 3) telehealth sessions with a therapist only, or 4) treatment as usual. Participants will: * Independently review Epilepsy Journey web-based modules focused on executive functioning skills (\~15-30 minutes) and/or have weekly telehealth sessions (\~30-45 minutes) with a therapist for 14 weeks. * Complete measures of executive functioning (parent and teen-report) and quality of life (teen-report) at the start of the study, 14-, 26-, and 66- weeks after randomization. The NIH toolbox will be completed at the start of the study and 26-weeks after randomization. Additional measures will also be collected.
The investigators propose addressing and evaluating the efficacy of a behavioral, contingency management app by conducting a randomized controlled trial (RCT) that will evaluate the app compared to a placebo app control group. Participants will be randomly assigned to immediate intervention using the treatment condition or to a placebo app condition. Participants will not know which condition they are assigned to until after the study completion; they will also not know that they are using the treatment app until after the study completion. The sample will consist of 100 families of school-age children (ages 6-12) who display significant behavioral problems. The treatment app is a task management platform containing a self-directed rewards system through which caregivers can assign token rewards to their children for completing routine tasks (e.g., cleaning their room, completing homework). Participants in the placebo app condition will have a similar user experience, however, tokens are assigned non-contingently (dispensed daily, rather than based on task completion). While participants will not be required to complete any tasks or behaviors in the app as part of their participation in the study, they will be asked to use the app at least once per day for 8 weeks. Given the self-directed nature of the treatment app (parents decide how frequently they access the app-based rewards system and how many tasks they assign to their child), parent involvement in the intervention will vary slightly in duration. However, based on the literature and routine practice, we anticipate parents will log in at least once a day to assign tasks to their child and follow up on completed rewards. Assessments (see details below) will occur at baseline, weekly during the intervention, and at the end of the study. The study will take about 8 weeks in total to complete once participants have been enrolled in the app.
The goal of this 13-year follow up of a randomized control trial is to study the effect of maternal choline supplementation on offspring cognition in adolescence. The main question\[s\] it aims to answer are: Does a higher dose of maternal choline choline (930 mg/d day supplementation) lead to improved cognition in adolescence including hippocampal-dependent episodic memory and executive functioning when compared to lower dose supplementation (480 mg/d). In this follow-up of a clinical trial participants will complete online cognition testing and emotion testing.
This project aims to examine the efficacy of remote, caregiver-led tES/brain stimulation intervention targeted to improve memory, mobility, and executive functioning among older adults with mild cognitive impairment or mild dementia.
Although many children diagnosed with autism spectrum disorder (ASD) make significant progress in learning and their cognitive skills improve with applied behavior analysis (ABA), there are a significant number of children who show an absence or a plateau in various skills. Deficits in executive functioning are likely to be involved in many of these cognitive and learning disabilities due to poor functioning of the prefrontal cortex. Currently, the use of biological methods for improving learning and cognition is largely unexplored in research and practice. The aim of this study is to use of transcranial direct current stimulation (tDCS) in combination with ABA to improve the acquisition of educational programs for students with ASD. tDCS is a low-level electrical neurostimulation and is most effective when used in combination with an active training or teaching, facilitating the neuronal circuits used for that task. tDCS has been used for various indications over a couple of decades and has been shown to be very safe and has been well-tolerated by children with ASD. The mechanism of tDCS is not clear, however animal studies show that tDCS can stimulate the flow of calcium ions through channels in the astrocytes, activating them, and facilitating their role in synapse formation and therefore learning.
Ventilated pediatric patients are frequently over-sedated and the majority suffer from delirium, a form of acute brain dysfunction that is an independent predictor of increased risk of dying, length of stay, and costs. Universally prescribed sedative medications-the GABA-ergic benzodiazepines-worsen this brain organ dysfunction and independently prolong duration of ventilation and ICU stay, and the available alternative sedation regimen using dexmedetomidine, an alpha-2 agonist, has been shown to be superior to benzodiazepines in adults, and may mechanistically impact outcomes through positive effects on innate immunity, bacterial clearance, apoptosis, cognition and delirium. The mini-MENDS trial will compare dexmedetomidine and midazolam, and determine the best sedative medication to reduce delirium and improve duration of ventilation, and functional, psychiatric, and cognitive recovery in our most vulnerable patients-survivors of pediatric critical illness.
The investigators aim to explore the effect of puzzle mobile or tablet-based games on problem-solving impairment resulting from a first-time stroke. This is a randomized-controlled trial with the intervention arm consisting of puzzle gaming applications and the control arm consisting of stroke-relevant educational videos provided and encouraged throughout the course of participants' acute inpatient rehabilitation stay.
The purpose of the study is to provide evidence of feasibility, acceptability, patient satisfaction, and patient perceived benefit of the Multicontext (MC) approach. The project consists of eight case studies of persons with acquired brain injury undergoing acute inpatient rehabilitation who have difficulties in completing multiple step activities due to deficits in executive function and/or visual perception. The MC approach provides a structured occupational therapy framework that provides guidelines for enhancing strategy use and self monitoring skills for person's with acquired brain injury.
The purpose of this project is to conduct a feasibility test of an ASD executive functioning intervention adapted for mental health settings, including examining the effectiveness and process of implementing this adapted intervention in community mental health programs.
In this project, the investigators will extend prior results of parent-reported executive function growth and symptom reduction in children receiving home-based treatment with the Collaborative Problem Solving treatment approach (CPS), with a particular focus on examining children who have attention deficit hyperactivity disorder (ADHD). The investigators will examine executive functioning (EF) of children who are receiving CPS, measuring EF with parent-report and objective computer-based tasks, at two timepoints: at the start of treatment and approximately four months later, and will collect symptoms at these plus three additional timepoints: at discharge, 6-months after discharge, and 12-months after discharge.