Auburn

Researchers are evaluating the effectiveness of a combined neurofeedback and transcranial magnetic stimulation TMS intervention for individuals receiving treatment for Alcohol Use Disorder. This study aims to assess how these techniques may influence alcohol use, craving, community functioning, employment status, aggression, antisocial behavior, and brain activity over time. Participants will be randomly assigned to one of several groups receiving four weekly sessions of different combinations of active or sham TMS and neurofeedback using fMRI. The TMS involves 10 Hz pulses delivered to the right dorsolateral prefrontal cortex. Neurofeedback sessions provide real-time brain activity information either from the participant or others. A control group will receive typical treatment without TMS or neurofeedback. Participants will attend an initial visit followed by weekly intervention sessions for four weeks. Monthly remote follow-ups will occur for up to 12 months, with MRI follow-ups at 6 and 12 months. Researchers will measure changes in alcohol use, craving, social and employment outcomes, behavior, and brain structure and function throughout the study period. Safety and adherence will be monitored continuously.

Researchers are conducting a long-term extension study to evaluate the safety, tolerability, and effectiveness of ORX750 in adults aged 18 to 65 years who have narcolepsy type 1, narcolepsy type 2, or idiopathic hypersomnia. This study follows participants who completed a previous ORX750 clinical trial and focuses on providing ongoing information about the treatment over an extended period. Participants will receive oral ORX750 in an open-label format, grouped by their specific diagnosis narcolepsy type 1, narcolepsy type 2, or idiopathic hypersomnia. The study does not involve randomization or blinding, allowing all participants to know they are receiving the study drug. The treatment and monitoring periods include assessments up to about 70 days for safety and roughly 63 days for measures of drug concentration and wakefulness. During the study, participants will undergo frequent evaluations including monitoring for adverse events, laboratory tests, vital signs, ECGs, and assessments for suicidal thoughts or behaviors. They will also complete tests measuring wakefulness and sleepiness levels. This ongoing observation aims to ensure the treatments safety and to understand its effects over time, with participant involvement lasting through the entire study period.

Researchers are studying ways to improve teaching self-control and communication skills to children and adolescents aged 6 to 17 with challenging behaviors. The goal is to find methods that make behavior-change treatments more effective and long-lasting, even when environments or reinforcement schedules change. The study looks at how cognitive and behavioral factors like memory, timing, and decision-making affect treatment success. Participants will receive a behavioral intervention that includes functional communication training to teach appropriate communication responses, extinction-correlated stimuli to signal reinforcement changes, schedule thinning to reduce reinforcement frequency, competing stimuli to reduce challenging behaviors during delays, and caregiver training to support skill use at home. These approaches will be personalized and applied in structured sessions. During the study, participants will complete assessments to identify preferred activities and understand causes of challenging behaviors. They will learn new communication skills to replace problem behaviors and practice transferring these skills to new situations and people. Researchers will monitor changes in challenging behavior from enrollment through 16 weeks of intervention to evaluate treatment durability and generalization.

Researchers are evaluating the safety, tolerability, and effects of ORX750 in adults with Narcolepsy Type 1 NT1, Narcolepsy Type 2 NT2, and Idiopathic Hypersomnia IH. These rare conditions cause excessive daytime sleepiness and affect daily activities such as school, work, and driving. The study aims to understand how ORX750, which mimics the brain protein orexin that helps maintain wakefulness, impacts sleepiness and other symptoms in these conditions. Participants will receive either ORX750 capsules or matching placebo capsules in a randomized, double-blind setup. The study assesses multiple groups those with NT1, NT2, and IH. The treatment and monitoring will occur over a period of up to 35 days, including evaluation of plasma drug levels and sleepiness measures. During the study, participants will undergo safety assessments including monitoring for adverse events, laboratory tests, vital signs, ECGs, and suicidal ideation screening up to day 35. Researchers will also measure sleepiness using the Maintenance of Wakefulness Test and the Epworth Sleepiness Scale. The total study duration for each participant is about five weeks, with careful observation of how the body processes ORX750 and its effects on daytime alertness.

Narcolepsy Type 2 NT2 is a lifelong condition causing excessive daytime sleepiness, difficulty staying awake, and problems with concentration and memory, impacting daily life activities. Researchers are evaluating TAK-360, a drug that acts like orexin, a brain chemical that promotes wakefulness, to understand its safety, tolerability, and ability to help adults with NT2 stay awake. This is a Phase 2, randomized, double-blind, placebo-controlled study to find the right dosage of TAK-360. Participants will be randomly assigned to receive either TAK-360 tablets or matching placebo tablets orally for 4 weeks. TAK-360 is being studied to assess its effects compared to placebo. The study uses a parallel design and includes a 4-week treatment period where participants take the assigned tablets daily. During the study, participants will be monitored for treatment-emergent adverse events for up to 15 weeks. Researchers will assess wakefulness using tools like the Epworth Sleepiness Scale and the Maintenance of Wakefulness Test at baseline and after 4 weeks of treatment. Safety, tolerability, and efficacy data will be collected throughout the study, which runs until November 2026.

This research aims to understand how brain activity in the medial orbitofrontal cortex influences the recognition of problems related to cannabis use in people with severe cannabis use disorder. The study tests whether changing neural activity using a non-invasive method called transcranial magnetic stimulation TMS can affect how participants recognize cannabis use-related issues. Researchers will compare three types of theta burst stimulation sham, intermittent, and continuous in each participant to explore these effects. Participants will receive three types of TMS a placebo sham stimulation, an intermittent theta burst stimulation iTBS, and a continuous theta burst stimulation cTBS. The iTBS involves 20 trains of bursts lasting 2 seconds each with short breaks, totaling 192 seconds, while the cTBS consists of a single 40-second burst train. Sham stimulation mimics the sound and sensation of active TMS without affecting brain activity. These sessions are spread across four in-person lab visits. During the study, participants will undergo questionnaires, four brief magnetic resonance imaging MRI scans, three TMS sessions, and three electroencephalogram EEG recordings. Urine samples and saliva or breathalyzer tests will be collected at some visits. Researchers will measure cerebral blood flow in the medial orbitofrontal cortex and brain responses to cannabis-related information to assess changes in problem recognition. The study runs from January 2026 to May 2027 and includes safety screening for MRI and TMS suitability.

Researchers are evaluating whether daily supplements of curcumin and epigallocatechin gallate EGCG can improve mood disturbance and increase serum brain derived neurotrophic factor BDNF levels in adults aged 18 to 50 who have moderate mood symptoms as measured by a depression scale. This randomized, placebo-controlled trial aims to understand the effects of these supplements on mood and brain health markers over an 8-week period. Participants will be randomly assigned to either the intervention group receiving 1,330 mg of curcumin and 350 mg of EGCG daily or a placebo group. The study lasts 8 weeks, during which participants will consume their assigned supplements each day. The trial includes baseline and follow-up assessments at weeks 0, 4, and 8, including mood questionnaires and blood tests to measure serum BDNF. During the study, participants will have blood drawn at the start and end of the 8 weeks to measure BDNF levels. They will complete mood and lifestyle questionnaires at weeks 0, 4, and 8 to track changes in mood disturbance, anxiety, stress, sleep quality, physical activity, and diet. Daily reminders will help participants adhere to taking their supplements. The main outcomes measured are changes in mood disturbance scores and serum BDNF after 8 weeks of supplementation.

This research aims to evaluate the effects of a four-week digital intervention designed to increase physical activity and reduce symptoms of depression among adults experiencing moderate or greater depressive symptoms. Researchers want to find out if using a digital program to encourage physical activity can help improve mood and increase exercise levels compared to no intervention. The study focuses on adults aged 19 to 40 with depressive symptoms and low physical activity. Participants will be randomly assigned to one of two groups. One group will use the Pathverse mobile app on their Apple or Android smartphone, which sends daily reminders to engage in physical activities they enjoy. They choose about five types of activity to do during the four weeks and report the type, duration, and intensity of each activity. The other group will serve as a passive control, having their mental health monitored without receiving the intervention, but they will be offered the app after the study if they want. Participants will visit the laboratory four times twice before and twice after the intervention, with one week of physical activity monitoring before group assignment and after the intervention. Researchers will assess depressive symptoms at multiple points, including before, during, and immediately after the intervention, and measure moderate-to-vigorous physical activity before and after the study. The study runs from September 2025 to May 2026 and is sponsored by Auburn University.

Researchers are evaluating whether a modified version of metaxalone 640 mg can reduce pain in adults aged 18 to 80 years who have newly occurring low back or leg pain due to acute lumbosacral musculoskeletal conditions with spinal stenosis and sciatica. This study is a phase 4, double-blind, randomized, placebo-controlled trial designed to compare the effects of the active drug with a placebo. The goal is to understand the impact on pain levels, physical activity, and sleep interference. Participants will be randomly assigned to receive either metaxalone 640 mg capsules or inactive placebo capsules. Both treatments are taken orally every six hours for seven days alongside standard care. The study includes an initial pilot phase followed by a larger randomized phase to ensure proper evaluation with adequate participant numbers. During the study, participants will complete surveys on day 1 before starting treatment and again seven days later to report on pain amount and quality, as well as how pain affects their physical activities and sleep. Researchers will monitor changes in pain using the Numeric Pain Scale from day 1 to day 7. The total participation involves these assessments and treatment over the one-week period with attention to any safety or health changes.

Researchers are evaluating the feasibility and acceptability of a 12-week Chair Yoga intervention for patients with heart failure. This pilot study involves a patient-centered approach, engaging stakeholders and patients to help design and refine the study protocol. The focus is on improving cognitive function and patient-centered outcomes in a rural heart failure population. The study is divided into two phases. In Phase 1, the first 10 patients will complete a 12-week online Chair Yoga program, with data collected before and after the intervention to assess feasibility. The protocol will then be revised based on patient feedback and stakeholder input. In Phase 2, another 10 patients will participate in the refined 12-week Chair Yoga intervention, followed by data collection to evaluate cognitive function and quality of life improvements. Participants will be assessed using tools such as the Essential Properties of Yoga Questionnaire to capture yoga experiences, the Montreal Cognitive Assessment for cognitive function, and the Minnesota Living with Heart Failure Questionnaire for quality of life. Social health factors will also be measured. The study spans several months and includes ongoing evaluation and protocol refinement, with findings shared with communities and stakeholders.