Cambridge

Researchers are studying how symptoms of postpartum depression PPD change in people starting treatment with zuranolone, a drug prescribed for PPD. This observational study collects health information without altering medical care, focusing on people in the United States who have a new prescription for zuranolone and were pregnant within the last 12 months. The main goal is to understand changes in depression symptoms using the Edinburgh Postnatal Depression Scale EPDS. Participants who receive a zuranolone prescription through Accredo Specialty Pharmacy will be invited to join the study. Before their first dose, they will complete online surveys about their symptoms and background. They must start taking zuranolone within 7 days of joining. Follow-up surveys using the EPDS will take place at days 15, 45, and 90 after starting the medication to track symptom changes and other factors like breastfeeding and medication use. Participants will provide information through multiple online surveys, each taking about 10 to 15 minutes. Researchers will assess changes in EPDS scores at several time points, breastfeeding status during treatment, and medication usage after zuranolone completion. The study aims to gather detailed, patient-reported data over a 90-day period without changing participants usual medical care.

Researchers are exploring a new surgical method for upper limb amputations to improve voluntary control and restore sensation and proprioception in amputated limbs. This phase I pilot trial will compare outcomes of modified above elbow or below elbow amputations with traditional amputations in adult patients. The study aims to develop a standardized procedure, measure motor control and proprioceptive feedback, and validate the benefits of the new technique over standard methods. Participants will receive either a modified amputation procedure that preserves or reconstructs dynamic muscle pairings and redirects sensory nerves, or a standard amputation without these modifications. The modified surgery targets specific muscles and nerves to create a biological interface that can better connect with next-generation prosthetic devices. Ten patients will receive the modified procedure and ten will undergo the standard approach, with some procedures performed at Brigham & Womens Hospital and others at Walter Reed National Military Medical Center. During the study, participants will be monitored for motor unit innervation, motor unit movement, and proprioceptive recovery over up to 36 months. Secondary outcomes include rates of infection, wound healing, surgical revisions, seroma formation, and mortality, as well as assessments of general health, muscle atrophy, and sensory recovery. Participants will provide feedback on their sensorimotor recovery and will be followed closely with various assessments to evaluate the functional and sensory outcomes of the new amputation technique.

This research aims to better understand the effects of nusinersen Spinraza4, a drug prescribed for spinal muscular atrophy SMA, on pregnant individuals with SMA and their babies. As treatment options allow people with SMA to reach pregnancy age, this observational study collects health information without changing medical care. The study compares pregnancy and birth outcomes among those exposed to nusinersen before or during pregnancy and those without SMA who havent received nusinersen. Participants include pregnant people with SMA from three SMA registries across different countries. The study observes those exposed to nusinersen within 14 months before the last menstrual period before conception, 14.5 months before conception, or anytime during pregnancy. Data is collected through registries, following participants until 3 months after delivery and their babies up to 2 years after birth. Participants provide health information each trimester, with doctors also contacted during pregnancy and after birth. Baby health is tracked at various ages up to two years. The study measures pregnancy losses, live births, birth defects, infant growth, and maternal and infant deaths up to 10 years. The overall study lasts at least 10 years from the first participants enrollment.

Researchers are conducting a survey to understand how well participants and physicians know how to use GATTEX, a treatment for Short Bowel Syndrome SBS, and to identify potential risks. This survey is part of a safety program called the Risk Evaluation and Mitigation Strategy REMS, required by the US FDA to ensure certain medicines with serious risks are used safely. The main goal is to assess knowledge about the necessary checkups and tests while using GATTEX and the possible risks involved. The survey is non-interventional and participants include those who have taken GATTEX within 60 days before the survey and healthcare providers in the US who have prescribed GATTEX at least once. The survey can be completed online, by telephone, or on paper, based on the participants preference. No study medicines are provided during this research. Participants will answer questions to measure their understanding of GATTEX safety and use. Researchers will count how many provide correct answers and how well they understand the knowledge areas of the survey. This assessment occurs every two years as part of ongoing safety monitoring. The survey aims to help improve safe use of GATTEX over time.

Researchers are studying a new surgical method for patients with lower extremity amputations. This approach aims to improve motor control, restore proprioception, reduce phantom limb pain, and reverse muscle loss in residual limbs. The study focuses on revising above knee and below knee amputations using innovative biological actuators. Participants will undergo a surgical procedure called residual limb revision, which constructs agonist-antagonist myoneural interfaces AMIs in their residual limbs. These biological actuators are designed to enhance muscle and nerve function, with the goal of improving movement control and sensory feedback. The study will also develop a specialized rehabilitation strategy tailored to this surgery. Throughout the study, participants will be monitored for changes in muscle volume, motor activation, sensory perception, proprioception, general health, and any complications. These measures will be collected over a period of one to three years post-surgery to evaluate the effectiveness and durability of the surgical revision and rehabilitation techniques.

Researchers are evaluating the ARC-IM System to manage symptomatic blood pressure instability in individuals with chronic spinal cord injury SCI lasting more than one year. This pivotal, randomized, controlled, and double-blinded study aims to assess the safety and effectiveness of the ARC-IM System. The main outcomes include subject-reported assessments and seated blood pressure measurements at three months after implantation. Participants will first undergo a baseline screening and surgical implantation of the ARC-IM System, which involves placing a lead and neurostimulator in the thoracic spinal area. After implantation, participants are randomized in a 21 ratio to receive either active electrical spinal cord stimulation starting immediately Group 1 or a sham intervention without active stimulation Group 2 for three months. After this period, all participants enter an open-label phase where they receive active stimulation and undergo therapy programming sessions. During the study, participants will perform therapy activation sessions within 21 days post-implant and then use the ARC-IM Therapy independently at home. Researchers will monitor blood pressure and assess outcomes through questionnaires and blood pressure tests at three months. Safety will also be evaluated through adverse device effect tracking at six months. Participants must comply with study procedures and device use throughout the trial, which lasts until the study completion date in March 2029.

Researchers are evaluating two different virtual, non-drug treatment options designed to improve the lives of adults with migraine. This randomized clinical trial focuses on behavioral interventions delivered through online group sessions and an accompanying online platform. The study aims to understand how these approaches may help manage migraine symptoms and related disability, while participants continue their usual medications. Participants receive either of two behavioral programs, each consisting of 8 weekly virtual group sessions led by an instructor, supported by an online platform with additional learning materials. The study is fully virtual, with no in-person visits required. Pregnant women up to 16 weeks gestation are eligible, and participants must complete technology onboarding to use the platform. During the study, participants complete an initial online screening, followed by a phone or video call to complete baseline assessments and learn to use the platform. They keep daily headache logs online and complete several surveys measuring migraine disability, depression, anxiety, pain catastrophizing, and quality of life at multiple points up to 32 weeks. This process helps researchers measure changes from baseline to immediately after the 8-week intervention and during longer follow-up periods.

Researchers are studying the effects of non-invasive 40Hz sensory stimulation using light, sound, and tactile devices on brain activity in cognitively normal, healthy adults. This pilot study aims to explore whether such stimulation can alter brain oscillations and connectivity, improve neuropsychological measures, and affect blood biomarkers and the microbiome. The study is motivated by findings that disruptions in gamma-band brain activity are linked to Alzheimers disease and cognitive impairment, and current treatments have limited effectiveness. Participants receive stimulation from devices delivering light and sound at a 40Hz frequency, including a light and sound device with LEDs and speakers and a wrist- or hand-worn device that provides tactile vibrations. The devices are used during a one-day visit at MIT, where participants experience the stimulation in a controlled setting while watching videos for entertainment. During the visit, investigators evaluate the effects and safety of the GENUS stimulation using EEG, MEG, MRI scans, neuropsychological testing, and blood sampling in some participants. The primary outcome is to measure changes in brain oscillations after one year. This study involves adults aged 18 to 100 years, and participants are monitored for any biological effects and safety signals throughout the process.

Alzheimers disease AD causes significant memory loss and involves harmful protein buildups amyloid and tau in the brain, along with changes in brain wave patterns called gamma waves. Researchers found that stimulating these gamma waves at 40Hz using light and sound helped reduce these proteins and improved memory in mouse models. This study is investigating whether a similar light and sound device can safely stimulate the brains of people with mild AD to potentially improve brain function. Participants will be randomly assigned to use a device at home for 60 minutes daily over six months. Half will receive active stimulation at 40Hz, while the other half will receive a sham inactive version. The study includes three in-person visits for assessments at baseline, three months, and six months. Participants may continue in an extension phase for at least one year, receiving the active treatment and yearly follow-up visits. Throughout the study, participants will undergo brain wave EEG tests, MRI scans, blood and fecal sample collections, cognitive and memory tests, and complete questionnaires. A wearable device will track sleep and activity. Researchers will monitor changes in brain function, molecular markers, microbiome, cognition, and safety. The study aims to understand if this non-invasive therapy can be a potential treatment strategy for mild to moderate Alzheimers disease.

Researchers are evaluating how combining brief periods of low oxygen breathing, transcutaneous spinal cord stimulation, and walking training may improve walking ability for people with chronic spinal cord injury. The study is based on previous animal and human research showing that mild low oxygen exposure, called acute intermittent hypoxia AIH, and spinal cord stimulation can each enhance neural connections and function after injury. This trial aims to test whether combining these methods with walking training offers greater recovery than either method alone. Participants will receive one of three treatments AIH before walking training with spinal cord stimulation, a sham version of AIH before walking training with spinal cord stimulation, or AIH before walking training with sham spinal cord stimulation. AIH involves eight sessions over two weeks where participants breathe low oxygen mixtures through a facemask in repeated episodes. Walking training lasts 45 minutes per session with either active or sham spinal cord stimulation, where stimulation intensity is adjusted based on individual motor thresholds. During the study, participants will be assessed on walking recovery using tests like the 10-meter walk test and 6-minute walk test over approximately 12 weeks. Other evaluations include pain severity, cognitive function, and monitoring for conditions such as hypertension and autonomic dysreflexia. The trial uses random assignment and triple masking to compare outcomes across groups. Safety and progress are monitored throughout, with participants engaged in interventions and follow-up assessments lasting about three months in total.