23 Clinical Trials for Various Conditions
The present study investigates how individual differences in cognitive processing contribute to the efficacy of working memory training programs in an older adult population. In a randomized crossover design, different types of working memory training interventions will be evaluated within the same participants. Adding game-like elements to working memory training programs can increase motivation and engagement, which can increase learning. However this process, termed gamification, adds sensory complexity that can lead to increased mental load and/or distraction in older adults. Investigators hypothesize that gamification of training tasks will be beneficial to some and counterproductive to other participants. The investigators will test two models; the first assumes that participants with difficulty inhibiting distracting information will show better learning and transfer when assigned to non-gamified training, whereas those with more distractor tolerance will show better learning and transfer when assigned to gamified training. The second model states that the outcomes of the intervention will be better predicted by performance on measures of general cognitive ability. In a separate study, the investigators will compare working memory training that contains rich, multisensory information with a training program that contains only visual information. Here they will also test two models; the first assumes that participants with difficulty binding two stimulus streams will show better learning and transfer when assigned to visual-only working memory training, whereas participants who do not have this difficulty will show better learning and transfer when assigned to multisensory working memory training. The second model states that the outcomes of the intervention will be better predicted by performance on measures of general cognitive ability.
This study examines the effects of placebo suggestions tailored to match or mismatch individual participants' motivational styles-an issue of person-situation 'fit' with important effects in public health settings, but which has been ignored in past research.
Females are increasingly using cannabis, yet remain underrepresented in preclinical and clinical cannabinoid research. This female-specific research plan will test the effects of two recreationally relevant doses of oral THC and placebo in healthy females at two phases of the menstrual cycle. Acute oral THC will be administered in a double-blind and counterbalanced design. Menstrual cycle phase will be determined using blood serum analyses of estradiol and progesterone and self-reported responses. The main hypothesis is circulating estradiol levels are associated with cardiac, neuroendocrine, and subjective THC response. The rationale for the presented work is to better understand the risks of cannabis use, in order to maximize possible medical potential and minimize public health risks. The expected outcome of this work is a deeper understanding of how circulating estradiol levels may associate with response to THC and how the physiological response is associated with the subjective response. Uncovering the individual differences in response to THC will allow for more preventive action against cannabis-induced anxiety, paranoia, and psychosis.
The purpose of the study is to gain a better understanding of pain processing in the brain. Our understanding of how pain is processed in the brain is limited. We are testing for individual differences in pain perception and emotion.
Hypertension is a common consequence of obstructive sleep apnea (OSA). However, not all individuals with OSA have hypertension and there are major individual differences in blood pressure response to positive airway pressure treatment of OSA. This project is focused on determining the basis of these individual differences in blood pressure response to OSA and will evaluate the possible underlying reasons for these differences. The results will help clinicians to know whether or not to expect a reduction in blood pressure (BP) to OSA treatment in a given patient and thereby personalize patient management.
The portion size of foods has been identified as an important determinant of energy intake in children. It remains to be determined to what extent child weight status and the relative reinforcing value of food may interact with the obesogenic food environment to affect energy intake. The primary aim of this study was to compare energy intake at a meal in normal-weight and obese children when the portion size of palatable, energy-dense foods and a sugar-sweetened beverage was systematically increased. We hypothesized that increasing the portion size of all foods and the beverage at a meal will lead to a significant increase in energy intake in both normal-weight and obese children. Obese children, however, will show a significantly greater increase in energy intake than will normal-weight children. A second aim of this study was to test if children's response to increases in portion size was affected by how reinforcing they find food to be. We hypothesized that, when controlling for BMI, children who find food very reinforcing relative to nonfood alternatives will show a significantly greater increase in energy intake than will children who find food less reinforcing.
The importance of exercise for weight control is well documented; however if exercise results in an increase in food intake, the beneficial effect of exercise may not be seen. This study addresses a gap in the current literature and examines why some people eat more after exercise and why some people eat less and also examines whether these responses are consistent over time. Participants in this study will be asked to come to our center on 7 different occasions over a 3-4 month period. The first visit will be an assessment visit where body weight and body composition will be measured, questionnaires will be completed, and an exercise test will be performed. During the remaining 6 visits (3 pairs of sessions with visits in each pair separated by 48-96 hours) the procedures will be nearly identical. Upon arrival at our center, participants will consume a meal replacement, complete a series of questionnaires and then either rest or walk on a treadmill for 30 minutes (3 days will be resting and 3 will be exercising). One hour following the exercise/resting session, individuals will be given access to a buffet of food, unaware that their food intake will be monitored. All food will be weighed and measured before and after the eating period and the amount of food consumed after each pair of exercise and resting conditions will be compared to one another. It is hypothesized that the difference in food intake will be consistent across pairs of testing sessions. Findings from this study will help us to better understand the relationship between exercise and food intake and may ultimately lead to future studies that can address the clinically significant question of why some individuals gain weight and others lose weight when engaging in exercise training programs. Findings from this study may also help to develop exercise programs that maximize the beneficial effect of exercise on body weight.
Background: - The risk for becoming addicted to drugs varies among individual, even those using similar drugs in a similar way. It is not known why some people become addicted and others do not. Studies suggest that some genes may increase the risk of addiction. Negative life experiences may also affect the risk of addiction. Researchers want to test smokers and nonsmokers to study genetic and brain function traits that may lead to drug addiction. Objectives: - To understand brain function in people who may be at a higher risk of drug addiction. Eligibility: * Healthy volunteers between 18 and 55 years of age. * Smokers (10 to 30 cigarettes per day for more than 2 years) and nonsmokers will be eligible. Design: * Participants will be screened with a physical exam and medical history. They will be tested for drug and alcohol use. A blood sample will be collected. * The study will involve one visit. Participants will have a magnetic resonance imaging (MRI) scan. * At the visit, participants will answer questions about their health and drug use habits. They will then be trained on the tasks they will do during the MRI scan. After the training, they will have the scan and perform the tasks. The scan and tasks will look at brain function related to rewards and impulsiveness. * Other computer tests will be given after the scan. These tests will measure learning, memory, and impulsiveness.
The study will evaluate the effectiveness of smoking cessation using Varenicline versus placebo. Effectiveness will be measured by the average number of cigarettes smoked per smoking day for up to 36 weeks.
The hypothesis for this study is that some individuals may be at much higher risk to develop type 2 diabetes and that the individual diabetes risk will be predicted by the individual level of slow wave sleep activity (SWA).
This study will examine the relationship between the amount of slow wave sleep (deep sleep) and the ability of the body to bring the blood sugar level to a normal range after receiving glucose.
Within-subject, double-blind, placebo-controlled examination of opioid abuse potential in healthy individuals as a function of A118G SNP on the OPRM1 gene.
The goal of this clinical trial is to examine the neural mechanisms underlying transcranial magnetic stimulation (TMS) using concurrent functional magnetic resonance imaging (fMRI) in both healthy controls (HCs) and patients with high negative affect symptoms, such as depression and anxiety. Approximately half male and half female participants aged 18-65 will be recruited. The main questions it aims to answer are: 1. Is the acute/transient effect induced by single-pulse TMS related to the long-term modulatory effect induced by repetitive TMS (rTMS)? 2. Do any of these effects predict negative affect symptoms, such as depression and anxiety? Participants will: 1. Complete several tests to assess their cognitive abilities and emotional states 2. Undergo several brain scans, including resting-state fMRI, structural MRI, diffusion tensor imaging (DTI), and task fMRI 3. Have two different types of TMS sequences, single-pulse and repetitive pulses, administered to specific brain regions while undergoing fMRI
The goal of this study is to investigate the finding that there are large individual differences in how participants move their eyes during active visual search. For example, some individuals tend to fixate, that is point their eyes steadily at a single location, for longer than other individuals before moving to another location. This experiment will use behavioral tasks to measure an individual's attentional and inhibitory functioning, and then see how each of these contributes to between-participant variability in eye movement behavior during visual search.
The goal of this early Phase 1 clinical trial is to assess if the social content of a story impacts autistic children's listening comprehension of stories. The main questions this study aims to answer are: * Does removing social content from a story improve listening comprehension in autistic children? * Does listening comprehension of more social versus less social stories differentially predict performance on a standardized reading comprehension measure? Participants will listen to more social and less social stories while viewing accompanying pictures and answer comprehension questions about the stories and complete a standardized assessment of reading comprehension. In addition, participants complete measures of their nonverbal cognition, hearing status, autism severity, language abilities, and social communication abilities to help characterize individual differences in participants.
Conscious attempts to regulate alcohol use are often undermined by automatic attention and arousal processes activated by alcohol cues, as well as by diminished ability to inhibit in-the-moment behaviors. The current study will examine whether a brief behavioral intervention of slow breathing paced at a resonance frequency of the cardiovascular system can interrupt automatic alcohol cue reactivity and enhance cognitive control in binge drinkers. Results from the proposed study may provide new prevention and intervention targets to interrupt unhealthy drinking behaviors.
The purpose of this study is to determine the effect of common human variants in in taste related genes, such as CD36 gene, a putative fat taste receptor, affect fat taste perception.
The goal of the project is to better understand executive control-how children manage complex or conflicting information in the service of a goal. This skill has been linked to social and academic functioning in typically developing children. Executive control is often reduced in children with autism spectrum disorder (ASD), but it has not been a focus of treatment. This project will have the goal of determining whether computer-training tasks developed to enhance the executive control skills of preschoolers and school-aged children without autism are appropriate for children with ASD. The investigators do not yet know if this training is beneficial for children with ASD. In addition, because executive control has been found to relate to social knowledge and problem solving, the investigators will collect information with this type of task to measure possible effects of training.
Strokes often cause a loss of communication ability, referred to as aphasia, as well as cognitive difficulties. Each stroke survivor has a unique pattern of strengths and weaknesses in communication and cognition, and a unique course of recovery. The BUILD study aims to understand the brain basis of these individual differences in stroke outcome. Participants with stroke as well as controls matched in age, educational background, race, and sex are examined using a combination of standardized and in-house tests of language and cognition to provide a detailed profile of strengths and weaknesses. Each participant will have between three and six sessions, including an MRI to measure details of the structure, function, and connections in the brain. The data are analyzed to test how patterns in the stroke lesion explain the patterns of communication and cognitive difficulties, and how patterns in the uninjured parts of the brain explain resilience and recovery from the stroke. Ultimately, we hope that BUILD will guide us toward new targets for brain stimulation treatments or other biologically based treatments that improve language and cognitive abilities after stroke.
This study will describe the use of an intervention, developed by an organization called Positive Exposure, to improve self-perceptions among adolescents and young adults who may encounter the stigma, or negative effect, of differences in their head and face. Photo-shoots and video interviews will be used. The combined use of those techniques is a new way to address aspects such as self-esteem, body image, and feelings of social awkwardness and anxiety-that is, a way that has never been systematically explored with people who have craniofacial differences. The conditions that participants in this study have will include cleft lip and palate, Apert syndrome, hemifacial microsomia, Treacher Collins syndrome, Mobius syndrome and Sturge-Weber syndrome. Among the goals of photography and video interviews are to help people to define themselves by their strengths rather than by their conditions; visually confront discrimination by others; investigate the possibilities for social support, networking, and creative problem-solving that can be developed for people with craniofacial conditions; and promote hopefulness for the future. Positive Exposure is a nonprofit organization founded in 1997. It investigates the psychosocial experiences of people who have genetic, physical, and mental conditions, among all ages and ethnic and cultural backgrounds of people. According to experiences of people with several conditions, participation with Positive Exposure has enhanced their feelings about themselves as attractive, capable individuals. Patients ages 12 years and older who have craniofacial conditions may be eligible for this pilot study. About 30 people will participate. Participants will be asked to provide the diagnosis of their craniofacial conditions. They will also be asked how many surgeries and what kinds they have had over the years, and how old they were at the time of the surgeries. This information will not be connected to participants' names and will be stored in a database protected by password. There are three parts to the study. In Part 1, patients will be asked to write a personal reflection (for as long as they wish) on their experiences of having their picture taken and being video taped. They will also fill out a brief survey, taking about 15 minutes. They are able to do this at home and will mail their responses to the researchers. In Part 2, they will take part in a photo-shoot (about 1 hour) conducted by the founder and program director of Positive Exposure and then take part in a video interview (about 30 minutes) conducted by a co-investigator from that organization. In Part 3, to take place 1 month following the photo-shoot, participants will write a final reflection that describes their experiences with Positive Exposure and then fill out another brief survey (about 10 minutes). Surveys used in the study will be the Self-Esteem Scale, Perceived Social Stigma Scale, and State Hope Scale. Photo-shoots and video interviews will be held at the studio of Positive Exposure in New York City or, if necessary, at a location closer to the participant's home. The projected time line of this pilot study is 10 months. Direct benefits are not the goal of participation in this study. However, participants may enjoy the photo-shoots and video interviews, as well as the process of reflecting and sharing their life and photo experiences with others. This pilot study will be a starting point for future research into Positive Exposure for adolescents and adults with visible genetic conditions.
The goal of this randomized cross-over mechanistic trial is to compare pre- and post-level cortisol and oxytocin changes in patients with chronic spine pain who receive either a hand's on (massage) or a hand's off (talk-based) approach. The study plans to address two primary aims. Specific Aim One: Directly compare pre- and post-session oxytocin and cortisol levels across two sessions of massage and talk-based therapy. Hypothesis 1: It is expected that in both treatments, oxytocin will increase and cortisol will decrease, demonstrating no significant between-group differences in hormone levels. Specific Aim Two: The study plans to compare pre- and post-session oxytocin and cortisol change scores a therapeutic alliance (TA) scale change scores and PROMIS patient-reported outcomes associated with pain, depression, and disability. Hypothesis 2a: It is projected that there will be moderate +/- relationships (R\>.4) between the therapeutic alliance change score and oxytocin and cortisol levels, suggesting that the hormones moderately reflect the construct associated with TA. Hypothesis 2b: It is expected that there will be weak (R\>.1) +/-relationships between hormone measures and PROMIS pain/disability/depression measures, which reflects similar findings to preliminary work. Participants will participant in a massage based treatment and a talk-based treatment approach. Participants will also complete patient report outcomes and will receive a total of four salivary swabs.
Background: Turner Syndrome, galactosemia, and premature ovarian insufficiency are all conditions that may make it very hard or impossible for a person to become pregnant and have their own child. Researchers want to learn more about why this happens and if freezing Gonadal tissue allows for fertility preservation. Objective: To find out why people with certain conditions have can have premature ovarian insufficiency (POI or early menopause) and individuals with variations in sex characteristics have trouble getting pregnant and if freezing the gonads tissue from them will help to have their own child in the future. Eligibility: Individuals aged 2-12 who have Turner Syndrome or galactosemia. Also, females aged 13-21 with premature ovarian insufficiency and Individuals with variations in sex characteristics Design: Participants will be screened with a medical history. Participants may have a physical exam and blood tests. Their body measurements may be taken. These include weight, height, arm span, skin fold, and sitting height. They may fill out surveys about their quality of life, body image, and health. Participants may have a transabdominal pelvic ultrasound. A probe will be placed on their belly and will take pictures of the organs in the pelvis. They may have a transvaginal pelvic ultrasound performed while asleep in the operating room if needed. Participants may have surgery to remove an gonads and skin biopsy. The removed tissue will be frozen and stored. The tissue will have to be stored for many years. NIH will pay to store the tissue for 1 year. After that, participants will have to pay for storage. A piece of the gonads (no more than 20%) will be used for research Travel, lodging and meals for participants traveling greater than 50 miles will be reimbursed based off the government rate. Local participants will not be reimbursed. Participants will have a checkup 6 weeks after surgery one or more follow-up visits 6-18 months after surgery. They may have phone follow-up every 12-24 months after surgery. Participation will last 30 years.
The purpose of this study is to explore sex differences in cognitive functioning and responses to marijuana-related items, and to determine whether stress impacts these measures. Hypothesis 1: Attentional bias will be greater for marijuana cues in male marijuana-dependent subjects relative to female marijuana-dependent or non-dependent male controls. Hypothesis 2: Marijuana-dependent females will exhibit greater stress-induced changes in attentional bias and cognitive functioning than marijuana-dependent males.