Boys Town

This study consists of 2 week screening period in which subjects who have consented will be evaluated for eligibility per protocol requirements. During this 2 week screening period subjects will be given access to ediary in which they will be required to self report symptoms of IBS-C daily. Information in ediary will also be used to determine eligibility prior to enrollment. During the 4 week RTP (Randomized treatment period), subjects will be randomized in in a ratio of 5:1 to receive tenapanor or matching placebo for 4 weeks. During the RTP, patients will continue recording daily assessments in the eDiary system as instructed and compliance with eDiary entries will be monitored. Patients will return for study visit every weeks (Visits 3-6) and will undergo safety assessments as per the protocol. At the end of this 4 week period, subjects will complete 2 week treatment free follow-up period and safety assessments per protocol will be conducted at the end of this 2 week period. The study plans to enroll up to 6 cohorts of eligible patients sequentially, starting from Cohort 1 with 12 patients randomized in to receive tenapanor 2 mg BID or matching placebo for 4 weeks. Subsequent cohorts will assess increasing tenapanor doses, following a dose escalation order. The study will proceed to the next dosing cohort if the current cohort completes the 4-week RTP and does not meet any of the dose escalation stopping criteria pre-specified in the protocol.

This research focuses on individuals with cerebral palsy, a group known to have lower levels of physical activity that negatively affect their overall health. The study aims to evaluate whether behavioral coaching can help increase daily steps, improve sensorimotor brain activity, and enhance functional mobility through clinical assessments. Participants will undergo baseline neuroimaging and mobility tests before starting the intervention. Participants will engage in an 8-week program where they receive behavioral coaching through motivational interviewing. Coaching sessions occur three times a week via video or Webex calls, lasting up to one hour each. During these sessions, trained staff discuss participants' progress, barriers to increasing activity, and encourage behavior change, all while wearing physical activity monitors to track daily step counts. Throughout the study, participants' mobility will be assessed using timed tests such as the Mobility Test, 5 Times Sit-to-Stand, and Timed Up and Go at baseline and after 8 weeks. Brain activity changes will also be measured. The study monitors progress through these evaluations to understand the impact of the coaching on physical activity and brain function in people with cerebral palsy.

This research aims to better understand the brain and spinal cord activity in people with cerebral palsy (CP), a common pediatric motor disability caused by early brain injury. Researchers are exploring how the sensorimotor cortex, spinal cord, and their connections differ in those with CP compared to neurotypical individuals. The study also investigates how these differences relate to the physical challenges experienced by people with CP. Additionally, the study evaluates the effects of noninvasive transcutaneous current stimulation on brain and spinal cord activity and connectivity in CP. Participants will undergo various interventions including clinical assessments of motor skills and sensory function in the hands, magnetic resonance imaging (MRI) and functional MRI to assess brain and spinal cord structure and activity, Hoffmann reflex tests to measure spinal cord responses, magnetoencephalographic (MEG) brain imaging during rest and movement tasks, and transcutaneous current stimulation applied over the cortex and spinal cord with sham control comparisons. These methods aim to reveal how stimulation impacts neural function and motor control. During the study, participants will complete clinical tests for upper limb function and sensory ability, undergo brain and spinal cord imaging and reflex assessments, and experience both real and sham stimulation sessions. Researchers will record and analyze video data and monitor neural activity to understand treatment effects. The primary outcomes include clinical motor assessments, brain and spinal cord imaging, Hoffmann reflex measures, MEG imaging, and responses to electrical stimulation. The study involves individuals aged 11 to 45 years with CP or neurotypical controls, with careful safety and eligibility monitoring throughout.

Researchers are evaluating the safety, effectiveness, and tolerability of tenapanor in children aged 12 to less than 18 years who have irritable bowel syndrome with constipation (IBS-C). This Phase 3 study is randomized, double-blind, and placebo-controlled, aiming to compare two doses of tenapanor (25 mg and 50 mg) taken twice daily over 12 weeks. The study includes an initial 2-week screening period to confirm eligibility and collect daily symptom data via an electronic diary (eDiary).