Clinical trials

A battery of physiological and behavioral data will be collected before and after application of eTMS. Participants will be veterans or first responders diagnosed with PTSD. Study will be a double-blind, sham-controlled, parallel group, randomized clinical trial.

Dietary factors contributed to nearly 50% of all cardiometabolic deaths in the US in 2012, making it one of the leading causes of preventable death in the US, second only to tobacco use. Human diets and food choices can't help but be influenced by the ubiquitous availability of processed foods of high-energy density and low nutrient content, consumption of which can lead to obesity, type II diabetes, heart disease, and other types of metabolic dysfunction. Surprisingly, food reinforcement does not rely on perceived energy density. Rather food reinforcement is associated with actual energy density and therefore, on an implicit knowledge of caloric content. That implicit knowledge must have a neural signature and a mechanism by which the gut communicates nutritive value to the brain. There is evidence, at least for fat and carbohydrates, that these pathways are separable, but terminate in a common neural structure, the dorsal striatum or caudate. This could be one mechanism by which modern processed foods high in both fat and carbohydrate are so sought after and readily consumed, In fact, when experimentally tested, fat and carbohydrate combinations were more reinforcing calorie for calorie than fat or carbohydrates alone and the level of reinforcement correlated with activity in reward- related brain areas. Beyond simple reinforcing value, it is known from the literature on drugs of abuse that the faster a drug is arrives at the brain, the higher it's abuse potential, however, little is known about how the kinetics of nutrient excursion influence food preference, choice, and brain activity. This project aims to test this specifically for carbohydrate reward.

Previous research demonstrates that 1) adherence to a DASH dietary pattern and diets low in certain UPFs are linked to lower likelihood of experiencing cognitive impairments in later life (Seago et al., 2025a, 2025b), that 2) engagement in cooking is linked to healthier eating, reduced UPF consumption, and higher food self-efficacy (Lahne et al., 2017), and 3) that cooking activity itself in midlife is associated with reduced incidence of dementia (Tani et al., 2026). There may be multiple pathways through which cooking engagement facilitates healthier cognitive aging- including the benefits of healthier meals on cardiometabolic and neural health, but also the role of cooking as a cognitively-engaging activity - one that has been identified as a potential contributor to cognitive reserve during aging. While at least one computerized cognitive training program is based on cooking activities and has demonstrated improvements to untrained EF processes in older adults, no intervention has used actual cooking as a form of cognitive training. Part of the promise of such an intervention is that this sort of activity, while still engaging EF processes in a way that might lead to generalizable improvements, is much closer to real-world instrumental activities of daily living and may reinforce consumption of a brain- and cardiometabolic- health promoting dietary pattern. This pilot study involves a randomized controlled trial of a behavioral change intervention to promote a healthy diet by increasing cooking self-efficacy (agency), and for this study, cooking self-efficacy is the primary focus.

Quantify the flow of a tactile signal from the stimulus at the finger at the peripheral nervous system (PNS), to the central nervous system (CNS), and to cognitive perception at the brain in young adults (Aim 1) and individuals with and without stroke (Aim 2).

Reward learning and decision-making processes, which operate largely outside of conscious control, shape food choices and eating behaviors. Excess adiposity is associated with differences in brain structure and functional connectivity underlying these processes, and insulin resistance, which commonly co-occurs with excess adiposity, has been linked with dopamine signaling that is crucial for these processes. However, whether and how excess adiposity and insulin resistance affect reward learning and decision-making remains poorly understood. This study will address that gap, examining the effects of excess adiposity and insulin resistance, and their interaction, on processes of reward learning and decision-making in food-specific and general contexts.

Study of LIFU on fMRI pain signals. Participants receive low-intensity focused ultrasound (LIFU) and fMRI scans to measure changes in both resting and heat pain signals. Physiology may also be measured. Questionnaires and symptom monitoring will take place. The study takes place over 4 study visits.

Individuals with Parkinson's Disease (PD) often have motor difficulties that can negatively impact daily activities and their quality of life. Research has shown that to slow the progression of these symptoms, patients should partake in effective physical rehabilitation. However, effective physical rehabilitation has many barriers, including timing, cost, and other personal or system-level challenges. The purpose of this study is to evaluate the haptic remote rehabilitation system for patients with PD using a randomized controlled trial (RCT) in a field environment.

This study will investigate the effects of normal-nicotine versus low-nicotine cigarette availability in the context of four tax proposals (Tobacco Parity, Nicotine-Content, Harm-Reduction, and Modified Risk Tobacco Product-based taxes) on tobacco product purchasing patterns in a virtual marketplace.

Type 2 diabetes (T2D) is a major chronic health condition which increases risk of coronary artery disease, frailty, cognitive decline, and mortality. Additionally, hypertension is a major comorbidity for individuals with T2D, further increasing the risk of adverse cardiovascular outcomes. The prevalence of both conditions increases with advancing age. There is an urgent need to identify new approaches to prevent the development of T2D and improve cardiometabolic health in older adults 50-70 years of age. Whole white potatoes are an unprocessed food rich in essential nutrients often under-consumed by Americans, including potassium, fiber, magnesium, vitamins C and B6, and phytochemicals. Each of these nutrients individually are associated with cardiometabolic health benefits. Potatoes account for a significant amount of the intake of these nutrients in the US diet and are well-positioned to be a foundational element of a healthy dietary pattern. However, there are few interventional studies evaluating the effect of potatoes on cardiometabolic health, and the evidence from observational studies is mixed, leaving a significant gap in knowledge regarding the potential for potatoes to be included in healthy dietary patterns. The results of our proposed study will provide foundational data that inform future dietary guidelines regarding the inclusion of white potatoes as part of a healthy US dietary pattern.

This study is being conducted to test a new intervention. We are interested in whether it is easy to use and complete and whether you find it helpful in reducing concerns about your eating.

This study consists of a randomized controlled trial assessing the acceptability, feasibility, and efficacy of the RELAX (Regulating Emotions Like An eXpert) Intervention. Following randomization, 30 families will receive the RELAX intervention and 30 families will receive psychoeducational materials as part of a control condition. Additionally, 10 families from the RELAX condition will participate in a pilot study and focus groups to give feedback on developed smartphone apps to support skill use during and following completion of RELAX.

Cigarette smoking remains common, particularly in rural areas, despite ample evidence that smoking causes cancer and respiratory disease. Successful smoking cessation yields the majority of its health benefits (e.g., avoidance of lung cancer) after years of sustained behavioral change; however, people who smoke cigarettes tend to show elevated rates of delay discounting (i.e., devaluation of delayed outcomes) and a bias for immediate gratification. The overall goal of this project is to develop different versions of an episodic future thinking intervention (i.e., visualization of the future) and test their feasibility and efficacy for smoking cessation in rural and urban populations.

In a within-subject design, cigarette smokers, stratified by age, will purchase tobacco products under three tax rate conditions based on abuse liability, that is taxes based on: (1) product category score (i.e. score ranging from 0-1 based on abuse liability effect sizes); (2) product category rank (i.e. position of a product relative to all others; e.g. 1st, 5th); and (3) product tiers (i.e. low-, medium-, high abuse liability), as well as a control. In the ETM, the effects of these interventions will be examined on cigarette demand and other products substitution. The investigators will use a repeated-measures (within subject) analysis of variance (ANOVA) to test if there are differences between conditions (i.e., tax proposals) independently for each product. The models will include study design parameters for order effects to account for counterbalancing the tax conditions in the ETM. Each tax condition will be compared to the control. All distributional assumptions will be checked prior to analyses and the appropriate transformations will be employed, if needed. For each significant result from the omnibus test, the investigators will perform planned contrasts to test the proposed hypotheses previously described. Note that the omnibus test can result in a significant finding while the contrasts of interest may be non-significant. In this case, the investigators will only report the results from the planned contrasts. Additional analyses might be conducted.

GLP-1 medication is being prescribed for weight loss. However, GLP-1 medication may adversely affect muscle mass and muscle function. Moreover, any loss of muscle mass or muscle function with GLP-1 treatment may impair balance and increase fall risk. This is a particular concern among older adults already susceptible to the common muscle strength and muscle function loss with age, yet there is little evidence among this population. This study will address a gap in knowledge regarding the effects of GLP-1 treatment on muscle mass, muscle function, and balance/fall risk among adults age 50 and older.

The FBRI VTC Neuromotor Research Clinic was established and opened in May of 2013 to provide intensive therapeutic services to individuals with motor impairment secondary to neuromotor disorders. It is direct by Dr. Stephanie DeLuca and based on the principles surrounding ACQUIREc Therapy. ACQUIREc Therapy is an evidenced-based approach to pediatric constraint-induced movement therapy, which refers to a multi-component form of therapy that is focused on helping children who have asymmetric motor abilities between the two sides of the body. Historically, ACQUIREc Therapy has the unimpaired or less impaired upper extremity constrained (by a cast or a splint) while also receiving active therapy from a specially trained therapist who shapes new skills and functional activities with the child's more impaired upper extremity but who is also a licensed Occupational or Physical Therapist (OT/PT). Therapy dosages are high much higher than tradition OT or PT - often lasting many hours per day, up to 6 hours a day, 5 days a week, for 2-4 weeks. Investigators have developed further treatments based on the same principles of intensive services combined with behavior shaping for other areas of the body that are also affected by weakness (e.g., the leg and trunk) also, but which usually do not involve constraint. These have been more generally labeled ACQUIRE Therapy. All forms involve intensive, play-based therapy for children with asymmetric motor impairments of the arms and hands. The primary focus of treatment is to facilitate the acquisition of new motor skills in the child's weaker body parts through high levels of intensive therapy using scientifically-based behavioral guidelines. Therapy is also delivered in naturalistic environments. ACQUIREc Therapy as a treatment method has been tested in two randomized controlled trials, and a specific manual for its implementation has been developed. Dr. (s) Ramey and DeLuca previously founded a similar clinic, The Pediatric Neuromotor Research Clinic, at the University of Alabama at Birmingham where Dr. DeLuca directed the research clinic for 13 years and oversaw the implementation of the ACQUIREc Therapy treatment protocol in more than 400 cases. This research will involve analyzing and interpreting the clinical data of children going through clinical procedures at the FBRI VTC Neuromotor Research Clinic. All participation is voluntary and no children will denied services if families choose not to participate.

This study will investigate the effects of a very-low-nicotine cigarette (VLNC) standard, e-cigarette price, and illegal cigarette price on illegal product purchasing and alternative product use in a virtual marketplace.

Study aims to examine the effects of noninvasive brain stimulation on brain signals. This insight may have potential clinical implications for addiction, pain, and mental health populations. Participants will receive MRI and CT imaging. Participants receive low-intensity focused ultrasound (LIFU) to temporarily change brain activity. Participants then receive fMRI scans to measure changes in both resting and cognitive brain signaling using structured tasks. Heart rate, blood pressure, respiratory rate, and skin moisture is monitored. Participants complete a battery of questionnaires, both behavioral and symptom monitoring. The study takes place over 4 study visits.

Animal and observational research in humans suggest that specific types of non-nutritive sweeteners (NNS) may impair glycemic control. However, whether NNS consumption impacts glucose homeostasis in middle-aged/older adults with prediabetes is unknown, and potential mechanisms by which this could occur have yet to be identified. The overall objective of this R21 proposal is to establish proof-of-concept for alterations in glucose homeostasis following intake of sucralose, but not aspartame, in middle-aged/older adults with prediabetes compared to a eucaloric diet with no NNS.

This study is a randomized controlled intervention trial in adults aged 50+ years with overweight or obesity, which will compare three groups with different diet prescriptions: 1) pre-meal water consumption (500 ml, before each main meal) with a hypocaloric diet; 2) 1500 ml water consumed throughout the day with a hypocaloric diet; 3) hypocaloric diet with no instructions regarding water consumption. Smart water bottles will objectively assess water intake timing and volume. Urine osmolality, urine volume, and serum osmolality will be used as objective indicators of compliance with the water intake prescription. We will investigate changes in perceived hunger and fullness and appetite-regulating hormones as potential mechanisms by which premeal water could improve appetite regulation. We will also investigate the impact of water consumption and hydration on executive function capabilities, which may influence intervention adherence. Although increasing water intake could be an effective weight management strategy, no evidence-based recommendations exist for the timing of water intake needed for this benefit.

Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population.

The goal of this clinical trial is to test the effect of a mindset management intervention on stress levels in women with infertility. The main question it aims to answer is: Can the Organic Conceptions approach decrease stress levels in women with infertility? Participants in both groups will be asked to complete three surveys at three time points. The intervention group will complete the Organic Conceptions program, while the control group will not complete an intervention. Researchers will compare the intervention group and control group to see if the Organic Conceptions mindset management program decreases stress levels in women with infertility.

This study examines how people respond to rewards and losses, and the extent to which these responses are linked or distinct among people experiencing depressed mood, anhedonia, and/or anxiety.

A growing body of research has highlighted the importance of frontal regions, at both the functional and structural levels, in age-related declines in attentional and cognitive processing. However, the underlying neurobiological pathophysiological changes in the brain that contribute to these declines are still largely unclear. The objective of this proposal is to investigate neural mechanisms of age-related attentional distractibility, focusing on the neural circuit initiated from the locus coeruleus (LC). In the current proposal, the investigators will test the hypothesis that the neural disconnectivity of LC with the salience network (SN) drives failures of ignoring distractors in older adults. The investigators will examine how LC-SN connectivity is associated with selective attention performance, and how improved LC-SN connectivity through a cognitive training program may lead to improved attentional performance.