13 Clinical Trials for Various Conditions
The current study's goal is to determine if a one-week break from social media in all forms has a beneficial effect on people's attention, as measured by the Sustained Attention to Response Task, executive function as measured by the Stroop test, and well-being.
The primary objective of this randomized, double-blind, placebo-controlled, cross-over study is to assess the acute effects of a novel ingredient, guayusa on alertness and mental fatigue compared to a placebo. This trial will utilize the COMPASS cognitive task and cognitive demand battery (CDB) and mood, motivation, and energy measures with assessments taking place at baseline, 60- and 120-minutes post treatment on three separate testing days separated by \~7 days.
This is a randomized open pilot trial enrolling up to 40 co-primary caregivers of children with LAD. Participants will be randomized to receive either mind-body resiliency group (SMART-LAD, intervention) or an evidence-based group intervention Health Education Program (HEP, control) which is a multiple behavior change program that addresses sleep, exercise, nutrition, substance use, and working with one's healthcare team. Both the SMART-3RP and HEP programs have been modified based on adaptions from our previous qualitative study.
This is a virtual, single-arm clinical trial that will last 28 days. Participants will drink 1 bottle of Proper Wild energy shot daily and complete questionnaires at baseline, day 1, day 14, and day 28. Attention deficit hyperactivity disorder (ADHD)-like symptoms, such as concentration, focus, and attention, will be evaluated at baseline and at each check-in. Likert scale responses will be examined from baseline to each check-in. Participant responses on product feedback will be presented as % scores.
Inattentiveness and impulsivity in healthy adults and individuals with attention deficit hyperactivity disorder (ADHD) diminish these individuals' quality of life. Cortical hypometabolism has been hypothesized to contribute to inattentiveness in ADHD. Transcranial photobiomodulation (tPBM) is a safe and non-invasive modality for activation of the prefrontal cortex. tPBM in healthy adults has been shown to augment brain oxygenation, cognition, and mood. The cognition-enhancing effect of tPBM on sustained attention in adults with ADHD remains unstudied. The investigators will evaluate whether tPBM administration to adults with and without ADHD can improve their attention. Each participant will be screened for eighteen criteria based on the Diagnostic and Statistical Manual (DSM-IV, text revised), using the validated instrument Adult ADHD Self-Report Scale (ASRS-v1.1). Blinded participants will be randomized into (I) Active-tPBM or (II) Sham-tPBM groups. After undergoing an 8-minute administration of Sham or 1064 nm tPBM to the lateral and medial right prefrontal cortex, each participant will complete a 14-minute, computer-based Conner's continuous performance task-3 (CPT-3). The investigators will examine whether adults with and without ADHD who receive Active-tPBM improve in measures of inattention, impulsivity, sustained attention, or vigilance compared to the Sham-tPBM group. Cognitive assessments of attention like the CPT-3 may evaluate the efficacy of tPBM to increase cortical metabolism in healthy adults and individuals with conditions like ADHD. The investigators anticipate their investigation will be a starting point for more sophisticated studies that focus on the implications of tPBM on cognition.
This is a multicenter pilot randomized controlled trial, with an active control condition, of the feasibility, acceptability, and preliminary efficacy of EndeavorRx in a cohort of survivors of acute lymphoblastic leukemia or brain tumor ages 8-16 who are \> 1 year from the end of therapy.
Childhood obesity is a critical public health problem in the United States. One factor known to contribute to childhood obesity is excess consumption. Importantly, excess consumption related to weight gain is not necessarily driven by hunger. For example, environmental food cues stimulate brain reward regions and lead to overeating even after a child has eaten to satiety. This type of cued eating is associated with increased attention to food cues; the amount of time a child spends looking at food cues (e.g., food advertisements) is associated with increased caloric intake. However, individual susceptibility to environmental food cues remains unknown. It is proposed that the prevalent practice of media multi-tasking-simultaneously attending to multiple electronic media sources-increases attention to peripheral food cues in the environment and thereby plays an important role in the development of obesity. It is hypothesized that multi-tasking teaches children to engage in constant task switching that makes them more responsive to peripheral cues, many of which are potentially harmful (such as those that promote overeating). The overarching hypothesis is that media multi-tasking alters the attentional networks of the brain that control attention to environmental cues. High media multi-tasking children are therefore particularly susceptible to food cues, thereby leading to increased cued eating. It is also predicted that attention modification training can provide a protective effect against detrimental attentional processing caused multi-tasking, by increasing the proficiency of the attention networks. These hypotheses will be tested by assessing the pathway between media-multitasking, attention to food cues, and cued eating. It will also be examined whether it is possible to intervene on this pathway by piloting an at-home attention modification training intervention designed to reduce attention to food cues. It is our belief that this research will lead to the development of low-cost, scalable tools that can train attention networks so that children are less influenced by peripheral food cues, a known cause of overeating. For example, having children practice attention modification intervention tasks regularly (which could be accomplished through user-friendly computer games or cell phone/tablet apps) might offset the negative attentional effects of media multi-tasking.
The aim of the study is to determine whether a neuroscience-inspired cognitive remediation video game (EVO) that targets the cognitive control network (CCN) will improve executive functioning (EF) and resilience to psychiatric symptoms in typically developing 6th grade students, unselected for specific psychiatric symptoms. The primary goals are to 1) determine if EVO will result in improved EF and lower internalizing (e.g., mood, anxiety) and externalizing (e.g., attention deficit/hyperactivity disorder, AD/HD) psychiatric symptoms, 2) evaluate whether the benefit experienced by youth changes depending on their level of life stress (e.g., academic or social difficulties), 3) determine if EVO will promote resilience to stress. The investigators will measure EF, symptoms, and stress using self- and parent-report questionnaires. Other secondary outcomes include information on behavior in the classroom and academic performance (i.e., grades) that we will collect via school records. The investigators hypothesize that engagement with EVO 20-minutes per day, 5-days a week across 4-weeks will improve EF, lower psychiatric symptoms, improve academic/behavioral functioning at school, and decrease maladaptive responses to stress.
Will targeted intraoperative exercises performed by surgeons during surgery, mitigate high physical and mental demands while enhancing performance during surgical procedures?
The proposed study will evaluate a new approach to cognitive rehabilitation of mTBI using a brain stimulation technique called "Remotely Supervised Transcranial Direct Current Stimulation combined with Cognitive Training" (RS-tDCS+) which has shown promise for improving complex attention in both healthy and clinical populations. RS-tDCS+ is a home-based, low-risk, non-invasive technique that is designed to boost cognitive training by enhancing learning and the brain's ability to reorganize connections. This study will evaluate RS-tDCS+ for improving complex attention in Active Duty Service Members (ADSM) and Veterans with a history of mTBI. Different tests of complex attention and symptom questionnaires will be used to determine the effects of real versus sham (placebo) RS-tDCS+. Second, the investigators will investigate electrical and connectivity changes in the brain associated with RS-tDCS+ using electroencephalogram (EEG) and magnetic resonance imaging (MRI). Third, the investigators will investigate the lasting effects of any observed changes by evaluating participants at 1 and 6 weeks post-treatment. Lastly, the investigators will explore the impact of individual differences (e.g., PTSD, depression, sleep quality, time since injury, baseline impairment, age, sex, ADSM versus Veteran) on treatment outcome.
The proposed study will evaluate a new approach to cognitive rehabilitation of mild traumatic brain injury (mTBI) using a brain stimulation technique called transcranial direct current stimulation (tDCS). Specifically, we will investigate how tDCS combined with cognitive training improves deficits to attention and working memory in Active Duty Service Members with a history of mild traumatic brain injury (TBI). Measures of attention-related brain activity, neurocognitive assessments, and self-reported clinical outcomes will be used to determine effects of tDCS vs. sham tDCS when paired with a cognitive training intervention. By doing this study, we hope to find a reliable, noninvasive, and efficient method of treating mild TBI cognitive symptoms.
Rationale: Mindfulness is a popular therapeutic strategy that has a growing body of evidence suggesting it can improve a wide range of physical and psychological symptoms. Yet, confusion exists as to why mindfulness is effective as well as the most effective ways in which to teach and practice mindfulness. The present study will test a mindfulness training protocol to better understand the most effective ways to teach and practice mindfulness. Intervention: A group of video game players, or "gamers", will be instructed on how to play a video game of their choice in a more mindful way and compare this to an activity of daily functioning (i.e., folding laundry). Outcomes from self-report measures taken both before and after study activities will be tested against a control group of gamers who will perform the same study activities without the mindfulness induction. Objective or Purpose: The purpose of the present study is to test the effects of a brief, standardized mindfulness prompt in order to better understand effective ways to train mindfulness concepts. The mindfulness prompt will be applied to an intrinsically motivated activity (i.e., video game play for experienced gamers) and an activity of daily functioning (i.e., laundry folding) in order to evaluate the different effects of mindfulness practice when implemented with a popular leisure activity versus a less engaging activity of daily living. Study Population: This study will include adult "gamers" ages 18-65. A gamer is someone who engages in some form of digital video game play for a minimal average of three hours per week. A pre-screening measuring will rule out any participants who do not play video games with enough frequency to be considered a gamer. Study sessions will take place remotely overseen via a Zoom-based video call with study personnel. Another exclusion criteria will be an inability to speak with study personnel via Zoom or do not have a private area to perform the study activities. Study Methodology: To address the aims of this study a mixed-method, between- and within-group, counterbalanced study design will be employed. Thus, participants will be randomized to either a mindfulness or control condition with pre- and post-study-task self-report measures collected at two separate study sessions in order to statistically analyze the study hypotheses. Study Aims: The present study has one primary aim and several secondary aims: The primary aim is to test the beneficial effects of a standardized, brief mindfulness induction prior to the completion of two different activities (i.e., play a video game or fold laundry). A secondary aim is to evaluate the impact that the type of activity has on one's ability to practice mindfulness. In addition to the primary and secondary aims, an exploratory analysis will be utilized in order to better understand what factors may have mediated the results from the first two aims. Study Outcomes or Endpoints: A main effect will be used to test the differences between the study manipulation (i.e., mindfulness prompt) and control (i.e., perform the task as you usually do) conditions. The primary outcome will be a self-reported state-mindfulness scale that measures the degree to which one "mindfully" performed a specific activity. Secondary outcomes will capture changes in emotions from pre- to post-activity, level of engagement or "flow" during the activity, enjoyment performing study activities, and level of focus/concentration during study activities. Follow-up: No follow-up is planned at this time. A baseline screening measure as well as in-session pre and post-study task questions will be the only data collected. Statistics and Plans for Analysis: For the primary aim of the study, a repeated measures multivariate analysis of variance (MANOVA) with a 2 (study group) X 2 (activity type) X 2 (state mindfulness) matrix. The second study aim will be tested with a repeated measures multivariate analysis of covariation (MANCOVA) with the covariates of changes in emotions from pre- to post-activity, level of engagement or "flow" during the activity, enjoyment performing study activities, and level of focus/concentration during study activities.
Cancer-related cognitive dysfunction (CRCD) affects up to 75% of patients receiving chemotherapy and older adults are at greater risk of developing CRCD, which can negatively affect their functional independence and quality of life. Memory and Attention Adaptation Training-Geriatrics (MAAT-G) is a cognitive behavioral therapy-based intervention tailored specifically for older adults and the feasibility of MAAT-G in older cancer survivors with Mild Cognitive Impairment (MCI) is being evaluated.